Europe’s Stand on Mesh

Europe’s Stand on Mesh

Sometimes I stumble upon something while I am searching for information to help another woman. That is exactly what happened when I came across a very important download. It answers a question, what do they feel about using mesh in Europe? What are their experiences?

We have the FDA which seems to have doctors on the panel who are paid by manufacturers and although the latest report states there are many problems with mesh and the tools used in mesh sling kits, they leave them on the shelf to injure more women. That is why I am angry with this board. It is not their lives that are suddenly changed by these products and they do not make sure it doesn’t happen to thousands of more women.

There are many, many complications to these implants and they devastate women’s lives, sometimes for the long term. Yet there is little justice. Lawsuits do not give badly injured women the funds to continue living in a dignified manner and they are unfair for most women. Not only that but once a settlement has been claimed these giant manufacturers do not have to do anything more or give any funding to cover future complications. They are exempt after the lawsuits are settled and these products are rarely recalled, if ever.

We all know that this would never happen in the Automobile industry. If there is one death from a car, the press is all over it and this has had a chain reaction to force manufacturers to comply with recalls and fixes to their products and they continue with this over the life of the car. But…. That never happens with medical products. Why? It is because the people who oversee these implants and drugs are ALL from the medical field. Are they receiving kickbacks?

The article I stumbled across has taken a vastly different approach to mesh implants and I am going to share with you paragraphs from this report and give you the link at the bottom of this blog. I have tried to make it easier to read and split it up into smaller paragraphs. Now here is some of the report. You should know that this report not only covers mesh used in women, but it covers mesh used in mesh and hernia repair.

Where appropriate, I have included links back to other blogs I have written in the past, so I suggest you first read the whole report, then go back to them.

Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR Opinion on The safety of surgical meshes used in urogynecological surgery


The SCENIHR approved this Opinion on 3 December 2015. Note the date. It is a much better report about these products and implants and these agencies are really stepping up to the plate. Why doesn’t OUR government?

The safety of surgical meshes used in urogynecological surgery

About the Scientific Committees

Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment.

The Committees also draw the Commission’s attention to the new or emerging problems which may pose an actual or potential threat.

They are: The Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external

experts.

In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA).

SCENIHR

This Committee deals with questions related to emerging or newly identified health and environmental risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk assessment bodies.

Examples of potential areas of activity include potential risks associated with interaction of risk factors, synergic effects, cumulative effects, antimicrobial resistance, new technologies such as nanotechnologies, medical devices including those incorporating substances of animal and/or human origin, tissue engineering, blood products, fertility reduction, cancer of endocrine organs, physical hazards such as noise and electromagnetic fields (from mobile phones, transmitters and electronically controlled home environments) and methodologies for assessing new risks. It may also be invited to address risks related to public health determinants and non-transmissible diseases.

Scientific Committee members Michelle Epstein, Igor Emri, Philippe Hartemann, Peter Hoet, Norbert Leitgeb, Luis Martínez Martínez, Ana Proykova, Luigi Rizzo, Eduardo Rodriguez-Farré, Lesley Rushton, Konrad Rydzynski, Theodoros Samaras,Emanuela Testai, Theo Vermeire All I can say to these doctors is “Thank you for doing your jobs”.

If you wish to contact them, here is their information.

Contact:

European Commission

DG Health and Food Safety

Directorate C Public Health

Unit C2 – Health Information and Scientific Committees

Office: HTC 03/073 L-2920 Luxembourg

SANTE-C2-SCENIHR@ec.europa.eu

There are many terms on this report you many not recognize and the glossary and abbreviations may help. You can copy them and print them out if you wish and that may help you understand what is being discussed.

BBREVIATIONS AND GLOSSARY OF TERMS

Amid Classification: The classification of materials used for Hernia repair based on their pore size, as reported in: Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia surgery. Hernia. 1997. 1:15-21

BOO: bladder outlet obstruction

EAU: European association of urology

ICS: international continence society

MUS: mid-urethral slings

OAB: overactive bladder

POP: pelvic organ prolapse

ppd: pads per day

RCT: randomised controlled trial

RP: retropubic

SIMS: single-incision mini-sling

SIS: single-incision sling

SMUS: standard mid-urethral sling

SUI: stress urinary incontinence

TO: transobturator

TOT: transobturator tape

TVT: tension-free vaginal tape

This, like the FDA’s report is very long so I am giving you some highlights, that mesh injured women would like to read.


Surgical meshes have been used since the 1950s to repair abdominal hernias and were then used in the 1990s for the treatment of male and female stress urinary incontinence (SUI), female pelvic organ prolapse (POP) and colorectal functional disorders (CFD).

More recently the use of synthetic mesh and biological materials has become common, requiring new surgical insertion tools and tissue fixation anchors. The use of meshes in surgery has been shown to be associated with various adverse complications such as infection, tissue extrusion, separation of vaginal epithelium leading to visualization of the mesh (mesh exposure), mesh shrinkage and adverse side effects including pain and sexual dysfunction. The European Commission has, thus, requested the SCENIHR to assess the health risks of meshes used in urogynaecological surgery.

The various options for the treatment of pelvic floor dysfunctions were reviewed based on the scientific literature and the guidelines from scientific societies and health authorities. Included were both non-surgical and surgical treatment methods.
Non-biological surgical mesh materials can be divided into three categories: non-absorbable synthetics, absorbable synthetics, and composites. Synthetic meshes that have been used with mono- or multi-filament structure are usually classified according to their mesh size as Types 1, 2, 3 or 4 (Amid Classification), where type 1 is with pores >75 μm, type 2 with pores <10μm, type 3 with micropores and type 4 with monofilaments and submicronic pores of <1μm. Today, type 1 polypropylene mesh is the most commonly used.

Clinical outcome following mesh implantation is influenced by material properties, product design, overall mesh size, route of

implantation, patient characteristics, associated procedures (e.g. hysterectomy) and the surgeon’s experience. The SCENIHR recommends that such aspects should be taken into account when choosing an appropriate therapy.

In assessing the risk associated with mesh application, it is important to consider the overall surface area of material used, the product design and the properties of the material used. The available evidence suggests a higher morbidity in treating POP, which uses a much larger amount of mesh compared to SUI.

When assessing synthetic mesh risks, there is a need to clearly distinguish between the risks associated with SUI sling surgery and

those of POP mesh surgery; sling surgery for SUI is associated with lower risks compared to POP mesh surgery.

The implantation of any mesh for the treatment of POP via the vaginal route should only be considered in complex cases, in particular, after failed primary repair surgery. Mesh exposure rates for vaginal POP surgery with mesh range from 4 to 19% (Milani et al., 2013). The use of autologous graft material is not feasible for POP because of the large mesh area required and the resulting donor morbidity. The use of absorbable mesh inserted either via a transabdominal or transvaginal route is associated with a high failure rate. Transvaginal surgery using non-absorbable synthetic mesh for POP involves a much greater surface area of mesh and is associated with a higher risk of mesh-related morbidity than seen with transabdominal insertion of mesh. Sacrocolpopexy is associated with greater surgical morbidity compared to vaginal repair.

In sling surgery, there is evidence that absorbable biological materials have a high failure rate while sling surgery with non-absorbable synthetic mesh was effective with an approximately mesh exposure rate of 4% (Brubaker et al., 2011). Autologous slings are a more invasive alternative (because of the need to harvest native tissue), but they also can be inserted using a minimally invasive approach. The traditional surgical approach of colposuspension is associated with greater morbidity compared to sling surgery with mesh.

The safety of surgical meshes used in urogynecological surgery safety in the majority of patients with moderate to severe SUI, when used by an experienced and appropriately trained surgeon. Therefore, the SCENIHR supports continuing synthetic sling use for SUI, but emphasizes the importance of appropriately trained surgeons and detailed counselling of patients about the associated risk/benefits.
Based on the available scientific evidence, the SCENIHR recommends

• the implantation of any mesh for the treatment of POP via the vaginal route should be only considered in complex cases in particular after failed primary repair surgery,

that due to increased risks associated with the use of synthetic mesh for POP repair via a trans-vaginal route, this option should only be used when other surgical procedures have already failed or are expected to fail.

limiting the amount of mesh for all procedures where possible. However, there is a need for further improvement in the composition and design of synthetic meshes, in particular for POP surgery.

the introduction of a certification system for surgeons based on existing international guidelines and established in cooperation with the relevant European Surgical Associations.

appropriate patient selection and counselling, which is of paramount importance for the optimal outcome for all surgical procedures, particularly for the indications discussed. This should be based on the results of further clinical evidence, which should be collected in a systematic fashion for all of these devices.

Their proposals.

Regulatory framework

Surgical mesh as a medical device Surgical meshes are produced by manufacturers to treat female SUI, POP or CFD, and

hence, because of their intended medical purpose, fall under the scope of the medical devices directive 93/42/EEC and amendment 2007/47/EC which contain the essential requirements of medical devices (Annex I), the conformity assessment procedure and

the obligations of manufacturers for placing medical devices on the European market.

Apart from specific design-related requirements such as on biocompatibility, stability and usability, which include protection from foreseeable error, mistake and misuse, general requirements demand that a medical device must:

• have an acceptable risk/benefit ratio;

• be designed based on state-of-the-art knowledge by observing the principles of inherent safety;

• achieve the intended performance;

• must not compromise the clinical condition and safety of the patients during the entire product lifetime as defined by the manufacturer;

•must not be adversely affected by transport and storage;

have risks from unintended side-effects limited to an acceptable level when weighed against the device’s benefits;

•be accompanied by all information required to use the device safely; and

• have been proven safe and effective by clinical evidence.


It continues.

The safety of surgical meshes used in urogynecological surgery

There is a large variety of surgical meshes with quite different performance characteristics related to:

•material (synthetic or biologic);

•shape;

•dimensions;

•filaments;

•pore size;

•thickness;

•knitting patterns;

•aging;

•extrusion/exposure;

•biocompatibility;

•instantaneous mechanical properties, such as – elasticity, -stiffness, and – bursting strength

•Time-dependent mechanical properties, such as – creep, – relaxation, – shrinkage, – degradation

In addition, mesh performance may critically depend on the directionality of the imposed mechanical load and/or how it was placed

and fixed into the surrounding tissue.

At the time of writing, there are no specific product standards on national, European or international levels. The available national standard in France (AFNOR NF S94-801) is restricted to requirements of preclinical and clinical testing of vaginal reinforcement implants for SUI and/or POP that requires that both preclinical and clinical studies be carried out before introducing any new implantable mesh, as well as post-marketing surveillance. There are only a few general aspects related to product design covered by

existing standards such as on biocompatibility (EN 10993-1 to EN 10993-20) or on bursting properties (EN 13938-1, EN 13938-2), however, a device-specific standard containing specific requirements on the device is still lacking, in particular with quantitative requirements, such as site-specific mechanical properties, material aging and degradation, inflammatory response to

the implanted materials (as demonstrated in animals), and minimization of mesh extrusion.

The conformity assessment procedure for CE labelling offers the manufacturer a choice among several modules, which depend on the intrinsic risks of a medical device for its intended use under normal conditions.

To account for the different hazard potential of the large diversity of medical devices, manufacturers must classify their devices into one of the four
risk classes I, IIa, IIb or III, based on the device’s intrinsic risks. This is done by applying 18 classification rules

as set out in Annex IX of the MDD 93/42/EEC and explained in guidance documents such as MEDDEV 2.4/1.

The European Union’s New Approach regulatory policy was adopted in 1986 and implemented for medical devices by the related Directives, among others. It offers manufacturers the possibility to replace third-party testing, even of critical devices, by their own self-responsible conformity assessments based on the condition that their quality management systems have been certified by a third party.

Because synthetic surgical meshes are less active than biological materials, implantable, and intended for long-term use, they belong

to conformity class IIb (otherwise class III). according to rule 8 of the MDD when lacking supporting pharmaceutical coating. This means that surgical meshes must either a) pass a third-party EC type examination by a European Notified Body (according to MDD Annex III) and requires the manufacturer to implement a quality management system (according to either MDD Annex IV, V or VI)

that is also certified by a European Notified Body, or, alternatively, b) manufacturers can

choose to implement a full Quality Management System (QMS), which must be certified

by a Notified Body.

In case a medical device compromises the health and/or safety of patients or other persons in spite of its correct installation, maintenance and use, adequate measures need to be taken by manufacturers, Member States and the Commission to remedy

existing non-compliances.

With regard to the involved procedures for all medical devices, conformity with the essential requirements must be based on a convincing clinical evaluation of available clinical data. In addition, manufacturers must implement a risk management process,

which includes a post-market surveillance procedure with active and continuous feedback data acquisition, monitoring and

risk assessment. Post-market surveillance must include both monitoring of complaints and adverse events, in addition to a regular

review and updates to the body of clinical evidence for the performance of the device.

The results of this regular surveillance must be assessed for potential subsequent application of routine risk reduction activities (e.g. improved instructions for use) and additional risk reduction activities (e.g. design changes, physicians’ education and training).

Evidence of this process is essential to ensure that the risk-to-benefit ratio for the device can be justified by a manufacturer.

Furthermore, any malfunction, deterioration in the characteristics and/or performance, inadequacy in the labelling or instructions for use of a medical device that might lead or might have led to a serious deterioration of a patient’s state of health or to his/her death, must be reported to the competent authorities.

Therefore, with regard to these obligations, sufficient clinical data should be available for surgical meshes to allow adequate risk assessment and identification of problems with their design and/or their use.

So how will they be required to treat patients?

Treatment I had no idea about many of these treatments, but I would be wary of becoming a guinea pig once again.

Before resorting to surgery, it is important to consider non-surgical solutions for SUI, POP and CFD with the patient.

If non-surgical options are not feasible, then the surgeon must decide whether to use a surgical approach with or without mesh, although currently, meshes are considered a primary surgical solution in

many cases of stress incontinence. All surgical approaches have risks and despite reported adverse events, mesh use still plays a primary role in surgery for SUI. Larger surface area meshes are needed for vaginal and transabdominal implantation for prolapse repair. For POP, the use of meshes is usually considered as a second choice after failed primary surgery.

There is a limited use of mesh for CFD in specialist centers.
Treatment without using meshes I left off the part about male mesh treatments, but you can read it if you wish to, on the link I will give you at the bottom of this blog.

Stress urinary incontinence (SUI)

o

Female Non-surgical treatment Guidelines from EAU (European Association of Urology), NICE / RCOG (United Kingdom),

CNGOF (College National des Gynécologues et Obstétriciens Français) and AFU (Association Française d’Urologie) (France), ACOG (American College of Obstetricians and Gynecologist) and ACP (American College of Physicians) (USA) recommend first-line

treatment with pelvic floor muscle training (PFMT) in women with SUI (Qaseem et al.,2014; Fritel et al.,2010; Smith et al.,

2013; NICE, 2013; Lucas et al., 2013).

Pelvic floor

muscle training should be as intensive as possible. Weight loss is recommended for obese women with SUI (grade: strong recommendation; moderate quality evidence).

No treatment

: Spontaneous resolution of symptoms: After 2-15 years’ follow-up, 2-30% of women with stress incontinence at any time appear to undergo spontaneous resolution of symptoms (Dolan et al., 2003; Heidler et al., 2007; Lifford et al.,2008; Jahanlu et al., 2008; Reynolds et al.,2011; Fritel et al.,2012). However, a reliable spontaneous resolution rate cannot be determined because population (age, menopausal status, etc.), follow-up duration and diagnosticcriteria (cure or just improvement) differ considerably between published studies.

Pads

: These are routinely used by women and, to a lesser extent, by men with incontinence (Brazzelli et al.,2002).

Weight loss: Randomised clinical trials show that in overweight and obese women, weight loss (>5%) is associated with a decrease in the prevalence of SUI symptoms and in stress-incontinence episodes (Subak et al.,2009; Wing et al.,2010).

The safety of surgical meshes used in urogynecological surgery 21

Medication

: Meta-analyses showed that medication with duloxetine is associated with a significant decrease in incontinence episode frequency when compared to placebo (Latthe et al.,2008; Li et al.,2013).

Local estrogens

: A meta-analysis showed that in post-menopausal women, there was some evidence that estrogens used locally (vaginal creams or pessaries) may improve incontinence (global urinary incontinence). However, according to the authors’ conclusions, there was little evidence from the trials on the period after oestrogen treatment had finished and no information about the long-term effects of this therapy was given. Conversely, systemic hormone replacement therapy using conjugated equine oestrogen may worsen incontinence. Moreover, there were too few data to reliably address other aspects of oestrogen therapy, such as oestrogen type and dose, and no direct evidence comparing routes of administration. The risk of endometrial and breast cancer after long-term use of

systemic oestrogen suggests that treatment should be for limited periods, especially in those women with an intact uterus. (Cody et al.,2012).

Pessaries

– Intravaginal devices: RCTs showed that the use of intravaginal devices / pessaries is associated with a decrease in incontinence episode frequency when compared to no treatment (Ziv et al.,2008; Cornu et al.,2013).

Urethral inserts

Urethral devices: The efficiency of urethral inserts has been poorly investigated. They are rarely used.

Physiotherapy

: Numerous techniques of physiotherapy have been reported and evaluated in the field of SUI. The main technique utilized is pelvic floor muscle training (PFMT). A recent review of PFMT in a Cochrane meta-analysis showed that in women presenting with SUI, PFMT was associated with higher cure rates (56% vs 6%, RR 8.3, 95%CI 3.6-19.0) when compared to no treatment (Dumoulin et al.,2014). No serious adverse events have been reported.

In addition to PFMT, adjunct physical therapies include:
Biofeedback (BF)

−Electrostimulation

−Magnetic therapy

−Weighted vaginal cones

−Bladder training.

Surgical treatment without mesh

Surgical approaches comprise:

Female

Colposuspension: Retropubic urethropexy: For this approach, several techniques are applied such as the Burch and Marshall Marchetti Krantz (MMK) techniques.

The Burch procedure is carried out via the abdominal route (open or laparoscopic). For an open technique, a Pfannenstiel incision

is performed. Post-operative pain in the Pfannenstiel scar has often been reported.

Open retropubic colposuspension is the most widely evaluated surgical technique for SUI. Open retropubic colposuspension is associated with high rates of objective and subjective cure rates, especially in the long-term (Lapitan et al.,2012). After 5 years, approximately 70% of women were still symptom-free or no longer complained of incontinence.

Laparoscopic colposuspension is associated with similar cure rates for SUI when compared to open colposuspension, but with a lower risk of complications and a shorter hospital stay (Dean et al.,2009).

Needle suspension: Several techniques using needle suspension such as Stamey, Raz, Pereyra and Gittes procedures have been described, but currently are rarely used.

Pubovaginal slings: Autologous fascial slings: This procedure is usually performed via an abdominal route. The autologous sling is made of a strip of tissue from the abdominal rectus fascia or fascia lata. Autologous fascial slings are associated with similar cure rates for female SUI when compared to open colposuspension, but with a higher risk of post-operative complications (bladder outlet obstruction, need for self-catheterisation, etc.) (Rehman et al.,2011; Albo et al.,2007).

Urethral balloon

: This technique is not recommended as a first-line surgical treatment for SUI (EAU, 2014 Lucas et al.,2013; Fritel et al.,
2010; Hermieu et al.,
2010).

Urethral injections: Injections of bulking agents seem to be associated with lower cure rates for SUI when compared to colposus

pension or autologous slings (Pickard et al., 2003). I do not know if many women have a bad reaction to builking agents, but I do know some have.

Stem cell periurethral injections – Cell therapy: There is insufficient data concerning periurethral stem cell injections (autologous myoblasts, muscle derived stem cells, autologous fibroblasts) that are supposed to treat intrinsic sphincteric deficiency (Aref-Abid et al.,2013).

Artificial urinary sphincter (AUS): The artificial urinary sphincter (AUS) in women has not yet been widely used nor evaluated in RCTs. This technique is not recommended as a first-line surgical treatment for SUI (EAU, 2014; Lucas et al.,2013; Fritel et al.,2010;

Hermieu et al.,2010).

Pelvic Organ Prolapse (POP) Non-surgical treatment

No treatment: Without treatment, spontaneous regression of symptoms and/or anatomical status in women with POP is common, but a large prospective cohort study concluded that a small proportion of women with symptomatic POP had progression within 5 years (Miedel et al.,2011; Bradley et al.,2007).

Taking no treatment but following lifestyle advice may also have some effect. Obesity may be a risk factor for POP and for POP recurrence following surgery, as well as other factors that increase intra-abdominal pressure (chronic heavy lifting, repetitive cough efforts, dyschezia/obstructive defecation syndrome). The prevalence of POP seems to be increased in women who report carrying out heavy lifting.

Being overweight or obese is associated with progression of POP. Weight loss does not appear to be significantly associated with the regression of POP, suggesting that damage to the pelvic floor related to weight gain might be irreversible.

Pessaries: Using intravaginal devices offer an effective and patient-reported satisfactory treatment. However, side effects exist such as vaginal (anaerobic) discharge or sequestration. Regular review is required and the discontinuation rate is very high at long-term follow-up (Bugge et al.,2013).

Physiotherapy: Pelvic floor muscle training should be the first line treatment for POP with or without pessary use, but the training needs proper instruction and close follow-up to be effective. PFMT is associated with a reduction in symptoms associated with POP and decrease in ICS (International Continence Society) POP-Q (POP Quantification system) stage 1/2 prolapse, although the clinical relevance of this improvement is not yet established. (Hagen et al.,2014).

Medication: Whilst local oestrogen therapy can provide good symptomatic benefit, there is no evidence that it corrects the anatomical changes of POP. A recent Cochrane review concluded that there was limited evidence from randomized controlled trials regarding the use of oestrogens for the prevention and management of POP (Ismail et al.,2010).

Surgical treatment without mesh

Cystocele repair: This procedure is done by the vaginal route (anterior colporrhaphy and vaginal, paravaginal repair). Anterior

colporrhaphy is performed by an anterior vaginal wall incision in the midline, and dissection to separate the vaginal epithelium from the underlying muscularis. This tissue is plicated in the midline using absorbable sutures.

Recurrence rates are high, particularly using anatomic outcome criteria (i.e. POP stage 2 or higher). However, when contemporary ‘functional’ outcome measures are used, that is (1) absence of bulge symptoms, (2) prolapse descent at or within the hymen, (3) absence of re-operation for POP, the success rate of this treatment at one year is reported at 88% (Chmielewski et al.,2011) This stresses the importance of the selection of clinically relevant outcome measurements. It is advisable to primarily use those that are important from a patient’s perspective (Toozs et al., 2012).

The objective of paravaginal repair by the vaginal route is to re-attach the detached lateral vaginal fascia to its ‘normal’ points of insertion on the lateral sidewall. There is very limited data about this technique (Maher et al.,2013).

Rectocele repair: The technique of rectocele repair (posterior colporrhaphy and site specific posterior repair) by the vaginal route consists of the correction of defects in the rectovaginal fascia separating rectum and vaginal mucosa (Maher et al.,2013). A midline incision is performed on the posterior wall of the vaginal mucosa. The vagina is dissected from the rectum in the midline. In posterior colporraphy, the recto-vaginal fascia is approximated in the midline either with continuous or interrupted absorbable sutures.

Apical repair: The treatment of uterine prolapse or vaginal apical prolapse depends on the patient’s characteristics (previous hysterectomy, concomitant hysterectomy) and the surgeon’s policy. The treatment of uterine/apical prolapse consists of hysterectomy+colpopexy or hysteropexy or colpopexy (Maher et al.,Cochrane 2013). The ‘pexy’ (suspension) may be performed using a sacrospinous or utero-sacral ligament suspension. Results associated with sacrospinous or uterosacral ligaments seem comparable (Barber et al.,2014).

Colpocleisis: Obliterative procedures such as colpocleisis (LeFort colpocleisis, colpohysterectomy, colpectomy) are offered to women with POP who no longer wish to preserve vaginal coital function. The technique consists of vaginal closure +/- colpectomy or colpo-hysterectomy. Colpocleisiss associated with high success rates, low rates of recurrence and low rates of complications, especially after the age of 80 (Sung et al.,2006; Fitzgerald et al.,2008; Mueller et al.,2014; Vij et al.,2014; Zebede et al.,2014).

Cystocele repair: Abdominal paravaginal repair via the abdominal route is performed through a Pfannenstiel incision (laparotomy) or laparoscopically. After entering the paravesical space and/or prepubic space, tears avulsing the pubocervical fascia from the arcus tendineus pelvic fascia (ATFP) are repaired by re-anchoring the detached anterior vaginal suspensory hammock to the pelvic girdle with interrupted non-absorbable or absorbable sutures (Reid et al.,2011).

Isolated abdominal hysterectomy: Isolated abdominal hysterectomy has not been evaluated for the treatment of uterine/pelvic organ prolapse.

Uterine suspension with anterior fixation or posterior uterine suspension using non-absorbable sutures has been widely reported by laparotomy or laparoscopy (Smith et al.,1977). The use of strips of skin (Poulhés et al., 1971) or fascia lata (Ridley et al.,1976) for uterine and bladder suspension has also been described.

Abdominal sacral hysteropexy/colpopexy: This procedure for uterine/vault prolapse uses mesh to secure the vagina up to the sacrumand is associated with a low complication rate (i.e., de novo dyspareunia and vaginal mesh exposure) because the vagina is not opened (Roovers, 2004; Maher et al.,2004). However, during 7 years of follow-up (Nygaard et al., 2013), abdominal sacrocolpopexy failure rates increased. Urethropexy prevented SUI longer than no urethropexy.

Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. In this study, mesh erosion probability at 7 years (estimatedby the Kaplan-Meier method) was 10.5%.

Abdominal uterosacral ligament suspension: The technique (colpopexy) consists of suspending the vaginal apex (mainly following concomitant hysterectomy) to the uterosacral ligaments, using non-absorbableor absorbable sutures, laparoscopically (Ostrzenski et al.,1996; Filmar et al.,

2014) or by laparotomy (Cunjian et al.,2012; Lowenstein et al.,2009; Crigler et al.,2012). However, Jeonet al.(2008) have shown that abdominal uterosacral ligament colpopexy (with concomitant hysterectomy) was associated with an increased risk of recurrence (6.2 times higher) when compared to abdominal sacral colpopexy with mesh and hysterectomy. Anterior abdominal rectopexy: Some authors reported anterior rectopexy for rectocele repair without mesh for the treatment of rectocele (Pironi et al.,2012).

Pelvic cul-de-sac (Douglas pouch) closure: This technique has not been evaluated for the treatment of uterine/pelvic organ prolapse as an isolated technique.

Colorectal Functional Disorders (CFD) In the following, the various treatment options will only be briefly mentioned, as CFD only marginally falls within the scope of this Opinion and most approaches have been described in previous chapters.

No treatment – Spontaneous resolution of symptoms −Weight loss −Medication −Pessaries −Physiotherapy −Pads – Plugs Surgical techniques without mesh −

Artificial anal sphincter −Abdominal route −Vaginal route −Perineal route −Trans-anal surgery.

I have had one heck of an education reading this report, which I feel is the most comprehensive report in one article. When they brought mesh on the market, there were reasons it was then declared to be the GOLD STANDARD of treatment. However, once things began going wrong, this treatment should have immediately been halted and reevaluated, before MORE women were doomed to a disabling and pain driven life. As the years of mesh using has gone on by, there are now FEWER doctors who are well trained in procedures without using mesh. NO woman should allow herself to be used as a guinea pig by a surgeon who considers him/herself as a God who can walk on water. These techniques MUST be taught long term BEFORE any doctor is let loose with a scalpel. Now read more.

Treatment using meshes

The aim of using meshes The rationale behind the use of synthetic meshes in urogynecological surgery was to increase the durability of surgical results, particularly with regard to the recurrence of pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI), and to reduce re-operation rates of POP.

Recurrence rates for using native tissues for these repairs is about 20-30% within 10 years of follow-up (Olsen et al.,1997; Denman et al.,2008).

For the vaginal repair of POP, synthetic materials have been used since the start of this millennium (absorbable mesh: polyglactin; Weber et al.,2001). In 2004, the wide spread introduction of non-absorbable synthetic meshes started, particularly distributed in so-called ‘mesh kits’ (synthetic polypropylene). It is unclear whether the use of these synthetic meshes/mesh kits has actually significantly reduced the rate of prolapse

recurrence and/or re-operations for POP in the longer term.

There are no scientific studies on long-term follow-up (e.g., 10 years) with randomized trials that compared the use of these mesh kits with native tissue

repair. These data are urgently needed to quantify the risk/benefit ratio of these treatments/biomaterials for pelvic floor reconstructive surgery. However, authorities have been critical about the efficiency of synthetic meshes in their reports.

Introduction

Biological grafts are alternatives to synthetic mesh. Autologous fascia is the most commonly used material with over 100 years of experience and good efficacy for the treatment of SUI. The main drawback, however, is the need to harvest the graft from a donor site (fascia lata from the thigh, or rectus fascia from the abdominal wall), and potential morbidity (e.g. wound infection, scar, nerve injury, hernia) (Birch and Fynes, 2002a). Additionally, there is a limitation on how much graft can be harvested. I have to inject here. From watching many, many women deal with the complications of mesh in their bodies and then having it removed, (including myself) I have seen the results of the initial gold standard treatment. That treatment causes so many complications and some are life threatening such as sepsis.

Not only that but the amount of nerve damage caused by these blind procedures I have NO DOUBT have surpassed any other complications of past treatments. Once you have gone through these surgeries, you WILL eventually run out of available fascia from a woman’s body. BUT… this is a reminder that the original fault was the so called gold standard of treatment in the first place. Once you are on this roller coaster, you cannot get off without major damage being done to your body.

This precludes its use in POP, which is associated with relatively large fascial defects. These problems can be avoided by using grafts derived from cadavers or, alternatively, animal- derived collagen matrices (e.g.,porcine dermis, porcine small intestine, bovine dermis). However, these materials require extensive processing (decellularisation, sterilisation and cross-linking processes) to resist degradation (Freytes et al.,2006).

While decellularisation renders materials non-immunogenic, both sterilisation (mandatory) and decellularisation may critically degrade their biomechanical properties. Cross-linking to improve strength of biomaterials can provoke a persistent inflammatory response associated with excessive fibrosis (Vangsness et al.,2003). Furthermore, there is the risk of viral or prion transmission (Birch and Fynes, 2002a). Although clinical studies are limited, clinical experience indicates that all of these natural materials appear to be associated with graft failure in the medium-term due to the body’s encapsulation and subsequent degradation of the materials with limited remodeling.

There are many factors that influence the response to biomaterials, which can be divided into 3 broad categories:

•(1) Chemistry and manufacturing influences on physical properties (e.g. their mechanical properties (stiffness and strength, porosity and degradability).

•(2) Nature of the patient’s immune response to the implanted biomaterials.

•(3) Surgical- and patient-specific factors (e.g. individual anatomy, co-morbidities). Currently, there are several hypotheses describing implant failure: (a) mechanical failure of the material (i.e., the materials do not have the appropriate mechanical properties), (b) enzymatic degradation resulting in mechanical failure of the material and (c) chronic inflammation leading to fibrosis and extrusion of the material through the host tissues.

Autologous materials Remember that this is using your own tissues.

Introduction

Autologous grafts harvested from the rectus fascia and fascia lata have long been used in SUI surgery. A major advantage of autografts over synthetic materials is that extrusion is almost unheard of (Golomb et al.,2001) and the overall long-term outcomes with autografts are largely excellent with

reported rates of cure generally over 90% (Morgan et al.,2000; Latini et al.,2004). Possible disadvantages of autografts are that the connective tissues of patients with SUI may be inherently weak which pre-disposes them to failure, and for POP surgery it is necessary to harvest adequate amounts of tissue.

Host response

Eleven reported studies suggestthat when autologous fascia is implanted, there may be a minimal to moderate inflammatory response, a moderate degree of collagen production and a suggestion that grafts undergo a degree of remodelling over the long-term (Dora et al.,2004; Hilger et al.,2006; Choe et al.,2001; Kim et al.,2001; Fitzgerald et al.,2000; Jeong et al.,2000; Carneiro et al.,2005; Krambecket al.,2006; Woodruff et al.,2008; Pinna et al.,2011; Almeida et al., 2007).

Allografts These come from cadavers and I know women who have had bad reactions from them, including abscesses which can lead to sepsis.

Introduction

Allografts used in pelvic floor reconstruction usually consist of fascia. The donors are screened for infectious diseases before the grafts undergo cleaning, freeze-drying and gamma irradiation to eradicate any infectious or immunogenic material. A concern with these grafts is that the donors are often elderly with age-related connective tissue weakening (Moalli, 2006), and inaddition, processing techniques such as freeze-drying and solvent dehydration may reduce tensile strength (Lemer et al.,1999).

Once again this is very important. There have been scandals over who collected cadaver tissue and where they came from. You can read about it for yourself. http://www.npr.org/2012/07/19/156988089/the-seamy-side-of-the-human-tissue-business

Cadaveric grafts are advantageous in that they avoid donor site complications. In terms of efficacy, results are mixed. Some have shown cadaveric fascia have similar subjective cure rates compared with autologous fascia at around 90% at 2 years (McBride et al.,2005). However, upon urodynamic testing, 42%of cadaveric graft patients had SUI, whereas no patients with autologous grafts had SUI (Howden et al.,2006). Five studies show disparate results (Hilger et al., 2006; Kim et al., 2001; Walter et al.,2003; Spiess et al., 2004; Rice et al., 2004)

Biomechanical properties

The available studies show disparate results with respect tothe changes in mechanical

properties of allografts following implantation which may be attributable to the heterogeneity in the type of allografts used, the animals studied, the sites of

implantation and the assessment at different time points.

Host response There have been many studies in which allografts have been implanted into animals and humans. The time since implantation ranged from 2 days up to 65 weeks (Hilger et al,2006; Krambeck et al.,2006; Woodruff et al.,2008; Rice et al.,2010; Sclafani et al.,2000; Yildirim et al.,2005; Vandevord et al.,

2010; Kolb et al.,2012).

Five of these report good integration into the abdominal wall (Scalfani et al., 2000; Kolbet al.,2012; Richters et al.,2008) and rectus muscle (Rice et al., 2010; Yildirim et al., 2005) in different animal models. However, others (Hilger et al., 2006; Krambeck et al., 2006; VandeVord et al., 2010) have found relatively poor cellinfiltration and fragmentation of the scaffolds. Overall there was a degree of agreement that allograft induces an acute inflammatory response around the grafts (Hilger et al., 2006; Krambeck et al., 2006; Rice et al., 2010; Sclafani et al., 2000; Yildirim et al., 2005; Vandevord et al., 2010; Kolb et al., 2012; Richters et al., 2008).

Xenografts

Introduction

Grafts from animals, mainly porcine and bovine, have been used in pelvic floor surgery. These materials undergo extensive processingafter harvesting to decellularise and render them non-immunogenic. Additionally, FDA regulations on animal source and vaccination status must be complied with (Amrute and Badlani, 2009). Porcine dermis may be artificially cross-linked using hexamethylene-di-isocyanate to make it more resistant to enzymatic digestion (Winters, 2006). Clinical studies showed lower continence rates for porcine dermis (approx. 80%) and increased re-operation compared to synthetic tape or autologous fascia Lucas M, 2004). Porcine small intestine submucosa (SIS) has cure rates from 79 to 93% at 2 and 4-year follow-up, respectively (Jones et al.,2005; Rutner

et al.,2003). However, one study raised concerns that SIS may not be strictly acellular and may contain porcine DNA (Zheng et al.,

2005), which, if present, would lead to an aggressive immune response and destruction of the implant.

Biomechanical properties

Non-cross-linked porcine dermal collagen matrix rapidly degrades within 3 months) and loses most of its mechanical integrity within this period. By contrast, cross-linked porcine dermal collagen matrix is more resistant to degradation and maintains its mechanical properties for at least 3 months, whereas SIS appears to increase in strength for as long as 2 years after implantation. It is well known that the degree of cross-linking affects the inflammatory response to materials – a little is fine, but too much leads to an M1 macrophage response.

The issue of how cross-linking affects natural collagenous biomaterials has been addressed in various studies. Studies on non-cross-linked materials show moderate remodeling, but often very rapid degradation. In contrast, cross-linked xenografts are associated with relatively little cell infiltration, more remodeling and in some cases, encapsulation of implants. (Cole et al.,2003; Badylak et al.,2001)

Host response

There have been an extensive number of studies looking at the extent of the inflammatory response of the host to xenografts, for example Hilger et al. and Pierce et al. found minimal neovascularisation and collagen ingrowth in porcine dermal xenografts (Hilger et al.,2006; Pierce et al.,2009b). In contrast, non-cross-linked SIS leads to high collagen ingrowth with a moderate degree of remodeling and orientation and high neovascularisation (Almeida et al.,2007; Rice

et al.,2010; VandeVord et al.,2010; Liu et al.,2011; Konstantinovic et al.,2005; Zhang et al.,2003; Ko et al.,2006; Badylak et al.,2002; Poulose et al.,2005; Rauth et al.,2007).

On the other hand, many studies agree in reporting a very rapid degradation of the SIS which is replaced by the host tissue [Liu et al.,2011; Zhang et al.,2003; Badylak et al.,2001; Badylak et al.,2002; Thiel et al.,2005; Daly et al.,2012; Suckow et al.,2012). Only two studies reported an absence of host fibroblast infiltration and fibrotic tissue penetration without neovascularisation for SIS implanted in rats (MacLeod et al.,2005) and rabbits (Krambeck et al.,2006). In humans, Cole et al. performed revision surgery on a patient who had developed a bladder outlet obstruction after SIS implantation and found that the implant had been encapsulated (Cole et al.,2003). Nevertheless, other investigators, at 12 and 48 months, respectively, found that the SIS was replaced by native humans (Wiedmann et al.,2004; Deprest et al.,2010). In summary, most studies suggest that the degree of cross-linkage affects the rate of degradation and the degree of the inflammatory response of the host. Cross-linked collagenous matrices induce little cell infiltration, hence there is limited collagen remodeling and graft degradation. In non-cross-linked xenografts, cell infiltration was greater with a faster degradation rate and collagen production.

I have never seen such a fantastically written report such as this and I believe the FDA should hire these people. Now let’s learn more about mesh.

Polypropylene

Introduction

There is a range of synthetic polypropylene meshes, which are summarized in Table 10. They are classified as Amid Classification Types 1, 2, 3 or 4 according to their pore size, where 1 is macroporous (>75 μm), 2 is less than 10 μm, 3 is microporous, and 4 is nanoporous (<1μm). Thus, a wide range of synthetic materials has been investigated for use in the treatment of SUI. These materials offer several advantages including lack of transmission of infectious diseases and easy availability, as well as sustainable tensile strength due to their potential non-degradable nature (Gomelsky and Dmochowski, 2007).

Mesh materials have been classified into 4 groups based on their porosity (microporous or macroporous) and filamentous structure (monofilament or

multifilament) (Amid et al.,1997), although a modified classification has recently been suggested (Klinge and Klosterhalfen, 2012) based on the following: (1) large pores, (2) small pores, (3) additional features, (4) no pores, (5) 3D structure and (6) biological origin.

The initial clinical experience with mid-type II (microporous/multifilament fibres, e.g. expanded PTFE), and III (macroporous and microporous/multifilament fibers, e.g., Mersilene) meshes was largely negative with excision rates of up to 30% for expanded PTFE (Weinberger and Ostergard, 1996) and extrusion rates of 17% for Mersilene (polyester) (Young et al.,2001).

A greater pore size is considered advantageous, as it allows the admittance of immune cells and greater collagen ingrowth into the construct (Birch and Fynes, 2002b). This is expected to reduce the risk of mesh infection and accelerate and enhance host tissue integration. Monofilament meshes are thought to reduce the risk of infection in comparison to multifilament meshes. The theoretical concern with the latter is that bacteria may colonize the sub 10 μm spaces between fibers, which are inaccessible for the larger host immune cells (9-20 μm) (Winters et al.,2006). This has come to pass with abscesses inside the mesh and risk of sepsis if not treated early enough. In fact, many women go to the E.R and they are close to death because doctors refuse to run a proper urine culture test which will tell the doctor how serious the woman’s infection is and how it should be treated.

Today, an Amid-type 1 polypropylene mesh that is macroporous and monofilament is most commonly used (Slack et al.,2006). Polypropylene maintains its strength after implantation for up to 24 weeks (Spiess et al.,2004; Zorn et al.,2007; Bazi et al.,2007). However, there is evidence that stiffness increases over time. (Melman et al.,2011; Mangera et al.,2012). Stiffness if more like rock hard balls of mesh that can cut inside our bodies and the penis of a man when having sex and it has eroded.

There is some evidence that meshes with greater stiffness cause the surrounding tissue to weaken; so-called ‘stress shielding’ (Feola et al.,2013). This may be compared to the effect of metal implants on the surrounding bone after orthopaedic surgery and could lead to thinning of the surrounding vaginal tissues and predispose extrusion. Yes, I know someone who is now dealing with something that feels like a spike when she sits. She just had a long scan to try to find out what it is. The problem with mesh it may not show up on a normal scan.

The following paragraph will tell about studies in animals. Everyone I have read said that there were numerous complications and YET the FDA allowed mesh to be placed in hundreds of thousands of women.

Biomechanical properties. Seven studies investigated the mechanical properties of polypropylene meshes with implantation times ranging from two weeks up to two years in animal models. Animal models used were rat abdominal wall (Spiess et al.,2004; Zorn et al.,2007), pig pre-peritoneal implantation (Boukerrou et al.,2007), rat rectus fascia (Bazi et al.,2007), mini-pig hernia repair (Melman et al.,2011) and ewe abdominal and vaginal walls (Manodoro

et al.,2013). Melman et al., (2011) tested Bard®Mesh, a knitted monofilament mesh made of High Molecular Weight Polypropylene (HMWPP) and Ultrapro®, a knitted macroporous composite mesh made of Low Molecular Weight Polypropylene (LMWPP) and polyglecaprone (Table 10). They were implanted in a mini-pig hernia repair model for up to 5 months. HMWPP decreased from 59.3 N maximal load at failure at 1 month to 36.0 N at 5 months, while LWPP mesh decreased from 61.5 to 37.8 N at 5 months (Melman et al., 2011).

Long-term studies were carried out by Zorn et al. (2007), where TVT and SPARC were compared to SIS in a rat abdominal wall defect for up to 12 months. Both

TVT and SPARC are macroporous meshes made of polypropylene monofilaments. SPARC did not change its mechanical properties after 12 months of implantation (maximum load mass at baseline 4.44 N, at 12 months 4.88 N).

By contrast the maximum load for TVT decreased from 7.64 N to 5.13 N for TVT and for SIS decreased from 3.94 N to 1.71 N (Zorn et al., 2007). Bazi et al.,also showed how similar the mechanical properties of Gynecare TVT and Advantage® are. Both are macroporous polypropylene monofilament meshes compared to other meshes such as IVS Tunneller, multifilament polypropylene mesh and SPARC.

The lowest, at 25.2 N, was TVT and the highest, at 34.9 N, was Advantage®, with no difference between them 24 weeks after implantation in rat rectus fascia (Bazi et al., 2007). Other studies agree with these parameters, where TVT complied with the highest break load (7.26 N), compared with 3.83 N for fascia lata up to 12 weeks after implantation in rat abdominal wall (Spiess et al., 2004), and

polypropylene was apparently less stiff thanother synthetic materials used for meshes (0.23 N/ mm compared with Nylon,6.83 N/mm) (Dietz et al., 2003).

Please go direct to the report to view the chart.

A recent study compared two sizes of meshes implanted in two different sites in a sheep model. Gynemesh was cut into two sizes (50×50 mm and 35×35 mm) and implanted in 20 adult ewes on the abdominal and vaginal walls for 60 and 90 days. After 90 days, grafts of both dimensions implanted on the vaginal wall were stiffer than those implanted

on the abdominal wall (Manodoro et al.,2013). I wrote a blog about this study and by reading this report it seems to have been the last study done of mesh in an animal.
http://www.meshangels.com/mesh-in-sheep/

Physical characteristics of the mesh, such as monofilament or multifilament, porosity and polymer molecular weight, hugely affect the mechanical performance of the implants in vivo. Figure 1 shows that except for polypropylene meshes, the degradation of mechanical strength can be dramatic for most meshes.
Host response

Twenty-one papers addressed the host response to polypropylene meshes, which were assessed in rat abdominal wall (Klinge

et al.,2002; Zheng et al.,2004; Konstantinovic et al.,2005; Thiel et al.,2005; Spelzini et al.,2007; Zorn et al.,2007), rat rectus fascia (Yildirim et al.,2005; Bogusiewicz et al.,2006; Bazi et al.,2007), rabbit bladder neck (Rabah et al.,2004), rabbit abdominal wall (Pascual et al.,2012), rabbit rectus fascia (Krambeck et al.,2006), rabbit vagina (Huffaker et al.,2008; Pierce et al.,2009b), mini-pig hernia, (Melman et al.,2011), pig peritoneum (Boulanger et al.,2006; Boukerrou et al.,2007), ewe vagina (de Tayrac et al.,2007; Manodoro et al.,2013), ewe abdominal wall (Manodoro et al.,2013) models and in a few clinical studies (Falconer et al.,2001; Wang et al.,2004; Woodruff et al.,2008; Elmer et al.,2009).

Studies focused on
acute inflammatory responses to the most commonly used, non-degradable meshes, as described in Table

10. A few investigators studied the acute inflammatory response occurring from the day of implantation up to 30 days (Klinge et al.,

2002; Zheng et al.,2004; Konstantinovic et al.,2005; Thiel et al.,2005; de Tayrac et al.,2007; Spelzini et al.,2007; Pascual et al.,

2012).

Other studies addressed the immediate response at 1-3 months’ post implantation (Rabah et al.,2004; Bogusiewicz et al.,

2006; Boulanger et al.,2006; Krambeck et al.,2006; Boukerrou et al.,2007; Huffaker et al.,2008; Manodoro et al.,2013) and long-term responses (>3 months) in which fibrosis and chronic inflammation are seen (Falconer et al.,2001; Wang et al.,2004; Bazi et al.,

2007; Zorn et al.,2007; Woodruff et al.,2008; Elmer et al.,2009; Pierce et al.,2009b; Melman et al.,2011).

A recent study by Manodoro et al., (2013) showed that 90 days after implantation, 30%
of Gynemesh grafts (50×50 mm) implanted in ewes caused vaginal extrusion and exposure and 60% of the smaller Gynemesh meshes (35×35 mm) had a reduced surface (i.e., contraction) (Manodoro et al.,2013). Falconer et al., showed that biopsies stained with Masson’s Trichrome following Prolene and Mersilene meshes induced a higher inflammatory response in Mersilene compared with Prolene, which only triggered a small inflammatory reaction (Falconer et al.,2001).

In a long-term study, Pierce et al., (2009b) compared biologicaland synthetic grafts implanted in rabbits and found that polypropylene caused a milder inflammatory reaction compared with a more long-term model withbetter host tissue incorporation compared to natural grafts. Furthermore, Bazi et al.,(2007) evaluated biopsies for inflammatory infiltrates, fibrosis, mast cells, muscular infiltration and collagen filling of the mesh on an arbitrary scale described as low, moderate or

extensive in H&E, periodic acid-Schiff and toluidine blue-stained tissue. This study concluded that all of the investigated materials

(Advantage, IVS, SPARC and TVT) induced inflammation and collagen production, with SPARC having the mildest response while TVT was associated with the highest adverse responses (Bazi et al.,2007).

In another study, Elmer et al., reported an increase in macrophages and mast cells and a mild, but persistent foreign body response to polypropylene meshes (Elmer et al.,2009) which was consistent with other reports in which polypropylene meshes were invaded with macrophages and leukocytes, inflammatory infiltrates and collagen production (Pascual et al.,2012; Pierce et al.,2009b; Woodruff et al.,2008; Bazi et al.,2007; Bogusiewicz et al.,2006; Yildirim et al.,2005).

In summary, polypropylene meshes provoke pronounced inflammation, leading to a massive cell infiltration into the scaffold and ultimately induce collagen production (Govier et al.,2004; Rabah et al.,2004; Wang et al.,2004; Bogusiewicz

et al.,2006; Bazi et al.,2007; Maia de Almeida et al.,2007; Huffaker et al.,2008; Woodruff et al.,2008; Elmer et al.,2009; Pierce

et al.,2009a).

If you want to learn more about the studies on hernia mesh, you will find it on page 33 through 34.

Implantation techniques for SUI

O Female patients

Implantation techniques of mid-urethral slings (MUS) Retropubic (RP) approach (bottom-to-top and top-to-bottom) MUS are placed by the vaginal route through the retropubic space using a specific device/needle and/or exteriorised through the abdominal skin using two millimetre incisions. Two techniques, bottom-to-top and top-to-bottom are used and are associated with complications such as bladder injury (6%), retropubichaematoma (<1%), iliac vessel injury (<1%), bowel injury (<1%), bladder outlet obstruction (BOO) (10%) that may require re-intervention for sling section (1%), vaginal sling exposure (1%), failure

at short-term follow-up (10%) and recurrence at long-term follow-up (10%) (Ogah, 2009; Schimpf et al.,2014).

My sling was a Boston Scientific Advantage Fit TVT. However, I had all the groin and thigh pain that is mentioned in the TO and mine is PERMANENT.

Trans-obturator (TO) approach (out/in and in/out) MUS are placed by the vaginal route through the obturator foramen (obturator and adductor muscles) using a helicoidal specific device/needle and exteriorised through the groin area skin using two millimetre incisions. Two techniques, the inside-outside and

the outside-inside, are used and are associated with complications such as groin/hip/thigh pain (10%), urethral or bladder injury (1%), vaginal injury (1%),

obturator haematoma (<1%) and bladder outlet obstruction (BOO) (10%) that may require reintervention for sling section (1%), vaginal sling exposure (1%), failure at short-term follow-up (10%) and recurrence at long-term follow-up (10%) (Ogah, 2009; Schimpf et al.,2014)

Prepubic approach MUS are placed by the vaginal route through a subcutaneous perineal route. This approach was less investigated, but seems to

be associated with lower cure rates (Daher, 2013; Long, 2013; Fritel et al.,2010).

Single incision slings (SIS) The risk of iliac vessel / bowel injury associated with the RP approach and the high prevalence of groin pain associated with the TO approach have led to the development of a new generation of MUS: the ‘mini-slings’ in which a single incision is made. The sling is significantly shorter in length compared with ‘classical’ RP or TO slings. However, there are no data regarding the actual length of the implanted sling compared with standard (‘classical’) RP and TO MUS procedures. The SIS is placed by the vaginal route, following a RP or a TO approach, but the sling is not trans-cutaneously exteriorised (the insertion stops short of the obturator membrane). The huge differences in the fixation mechanism of these SIS may influence outcomes (cure and complications rates). This less invasive technique is supposed to decrease complication rates, but the shorter length of the sling may be associated with lower cure rates, especially at long-term follow-up. Some SIS are partially ‘adjustable’ (per-operative adjustment), which makes it possible to adjust the tension of the fixing system. Many women who had the mini slings have the same complications as the others.
Read this blog http://www.meshangels.com/mini-arc-system/

An updated systematic review and meta-analysis of randomised controlled trials (RCTs) was recently performed comparing single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS) in the surgical management of female stress urinary

incontinence (SUI) (Mostafa et al.,2014).

A literature search was performed for all RCTs and quasi-RCTs comparing SIMS with either transobturator tension-free vaginal

tape (TO-TVT) or retropubic tension-free vaginal tape (RP-TVT). The literature search had no language restrictions and was last

updated on May 2, 2013. The primary outcomes were patient-reported and objective cure rates at 12 to 36 months follow-up. Secondary outcomes included operative data; peri- and post-operative complications and repeat continence surgery. Data were

analyzed using RevMan software. Meta-analyses of TVT-Secur vs. SMUS were presented separately as the former was recently withdrawn from clinical practice.

A total of 26 RCTs (n=3308 women) were included. After excluding RCTs evaluating TVT-Secur, there was no evidence of significant differences between SIMS and SMUS in patient-reported cure rates (risk ratio [RR]: 0.94; 95% confidence interval [CI], 0.88–1.00) and objective cure rates (RR: 0.98; 95% CI, 0.94–1.01) at a mean follow-up of 18.6 months. These results were derived by comparing SIMS versus TO-TVT and RP-TVT separately. SIMS had significantly lower post-operative pain scores (weighted means difference [WMD]: −2.94; 95% CI, −4.16 to −1.73) and earlier return to normal activities and to work (WMD: −5.08; 95% CI, −9.59 to −0.56 and WMD: −7.20; 95% CI, −12.43 to −1.98, respectively). SIMS had a non-significant trend towards higher rates of repeat continence surgery (RR: 2.00; 95% CI, 0.93–4.31).

This meta-analysis showed that, excluding TVT-Secur, there was no evidence of significant differences in patient reported and objective cure between currently used SIMS and SMUS at midterm follow-up while associated with more favourable recovery time. Results should be interpreted with caution due to the heterogeneity of the trials

included.

Other MUS procedures −Intermediate length slings In an effort to maintain efficacy while reducing some side effects, manufacturers developed hybrid procedures using shorter slings (12 cm), that are placed using a classical TO placement technique (Waltregny et al.,2012; de Leval et al.,2011).

However, RCTs with larger sample sizes and long-term follow-up are required before drawing conclusions. −Adjustable MUS (post-operative adjustment) No RCT has assessed adjustable MUS.

There are more about male slings which I am not including. You can find it beginning on page 36. You can also read more about abdominal meshes following the male sling report. You will also read a lot more about follow-ups and how long the cure rate is using various techniques.

Adverse events

In a two-year follow-up study, which prospectively evaluated TO and RP MUS, a total of 383 adverse events were observed among 253 of the 597 patients (42%). The safety committee considered that adverse events (20%) were considered serious and occurred

in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the RP group. Neurological adverse effects were

more common in the TO group than in RP group (32 events vs 20 events respectively). 23 (4%) women experienced mesh complications including delayed presentations in both groups. (Brubaker et al.,2011)


Guidelines on surgical treatment for women with SUI

Guidelines from EAU (European Association of Urology), NICE / RCOG (United Kingdom), CNGOF (College National des Gynecologues et Obstétriciens Français) & AFU (Association Française d’Urologie) (France), AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften) (Germany, Austria, Switzerland), ACOG (American

College of Obstetricians and Gynecologist) and ACP (American College of Physicians) (USA) recommend first-line treatment with MUS (RP or TO) (grade: strong The safety of surgical meshes used in urogynecological surgery recommendation / Grade A; high quality evidence / LE 1) (Qaseem et al.,2014; Fritel et al.,2010; Smith et al.,2013; Lucas et al.,2013; Reisenauer et al., 2013).

Second-line surgical therapies (open or laparoscopic colposuspension or autologous fascial slings) should be offered, if MUS cannot be considered (Grade C).

Next there is more about male slings and many charts.

While reading this conclusion I am sure, like me you will differ as to some of this, which is why it is so important for the women of the world to report their complications and do a follow up report for any complications you had before surgery, announcing your permanent condition and complications after removal surgery. When you file your report with the FDA in this country, you will receive a letter in the mail a couple of weeks later. On that letter will be a filing number and you can use that to do your update.

Note; I had to look up the definition of De Nova and in medical terms it means ‘from the beginning’. I am not sure exactly what this word means in this concept. It is not in the glossary of terms so I can only guess. It is not a word I have grown up with or use and because I was raised in England I do use many words and understand many that are not normally used in the U.S. I will ask a friend to define it for me because she teaches biology. Then I will add an update.

Conclusion

For the anterior vaginal compartment, there is convincing evidence that the use of a synthetic mesh to repair a prolapsed anterior vaginal wall is subjectively and objectively superior to a native tissue repair. There is, however, no difference in health-related quality of life between mesh and native tissue repair. The rate of de novo POP of the untreated vaginal compartment is significantly higher when synthetic mesh is used.

There is no evidence for a difference in the need for subsequent operations for POP or the occurrence of de novo dyspareunia or sexual function. The use of mesh results in higher rates of reported SUI, although this was not reflected in a higher rate for SUI surgery. Mesh exposure is reported frequently.

For the posterior vaginal compartment, there is moderate evidence that the use of mesh results in higher rates of objective cure and de novo POP of the anterior vaginal compartment, but no differences in subjective cure or de novo SUI. Mesh exposures are reported frequently.

For the treatment of more than one vaginal compartment, the meta-analysis showed that the use of mesh resulted in higher rates of subjective and objective ‘cure’, but also in significantly higher rates of de novo POP of the untreated vaginal compartments.

There were no differences in patient satisfaction; health-related quality of life, subsequent operations for POP, de novo dyspareunia, sexual function scores or

de novoSUI. Mesh exposures, however, were frequently reported.

The follow-ups of selected papers for that meta-analysis were mainly short (12 months) and sometimes medium-term (36 months). Long-term results (5-10 years) of RCTs are not yet published and, thus, are yet unavailable for analysis. There are many women I know who did not have complications for many years and I hope they report their long term results to the FDA. Number of years and what happened would be extremely important.

Adverse events −Mesh exposure

Mesh exposure is the condition whereby synthetic mesh isdisplayed/exposed (usually visualised through separated vaginal epithelium) (Haylen et al., 2012) and is the most frequently reported complication with rates ranging from 4-19%. These exposures can cause pain during sexual intercourse, cause blood loss or foul vaginal discharge, but can also be asymptomatic. The risk of exposure increases with tobacco use (OR 3.1; 95% CI 1.1-8.7), decreased clinical experience of the surgeon (OR: 2.0; 95% CI 1.2-3.4) and with the use of a ‘total’ (that is anterior and posterior) mesh (OR: 3.0; 95% CI 1.2-7.0) (Withagen et al.,

2011). Don’t you just love the comparison with tobacco? Tobacco is a chosen habit NOT an implant.

−Dyspareunia

Pain during sexual intercourse is frequently reported by women suffering from pelvic organ prolapse and usually diminishes after surgical repair of the prolapsed vaginal compartments. In a systematic review of 54 studies on 4566 patients, the dyspareunia rate after a vaginal mesh procedure was reported to be 8.9% (range; 0-67%; 95% CI 8.0-10.0)(Abed et al.,2011). Randomized trials comparing vaginal mesh versus native tissue repair surgery however did not demonstrate a difference in de novo dyspareunia, nor in post-operative dyspareunia (Milani et al.,2013; Dietz and Maher 2013). The most important risk factor for post-operative dyspareunia was pre-operative dyspareunia. (Withagen et al.,2011). I know many women whose complications and the trauma over the years of seeing doctor after doctor, having surgery after surgery who can’t face sex due to pain. The results for so many have been separation and divorce. I wonder if that was in any of these studies. I hope women who read this will have the courage to leave a comment and say what these implants have done to their lives.

−Pain

Pain is a complication that can occur after any surgical repair of vaginal prolapse. Pain caused by shrinkage of vaginal tissue caused by an excessive inflammatory reaction against the polypropylene mesh, which acts as a foreign body, is of a different nature and can be serious and difficult to treat. Pain in the lower abdomen or pubic region 12 months after a mesh augmented prolapse repair is reported by between 3-10% of patients. Randomised studies however could not demonstrate a difference between a mesh-augmented and a conventional native tissue repair of POP. (Milani et al.,2013; Withagen et al.,2011)

−Other complications

Other complications that can occur after vaginal mesh surgery are haemorrhage, bowel and or rectal injury, urinary infection and post-operative retention. These complications also occur after native tissue surgery.

Guidelines on surgical treatment for women with PO

The objective of this paragraph is to describe the main recommendations concerning POP surgery in Europe and the USA. The reported recommendations have been elaborated by international (IUGA, EAU) or national scientific societies in the UK, Netherlands and France.

List of existing recommendations:

– IUGA roundtable (2011): Davila et al.,2012; Slack et al.,2012; Winters et al.,2012; Miller et al.,2012.

– Dutch guidelines on mesh surgery in POP surgery and MUS (2012, updated in 2014).

– French guidelines on mesh placement in POP surgery (2011 and 2013).

The UK’s National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland.

– NICE was notified of various procedures for the treatment of POP. NICE asked the Review Body for Interventional Procedures to undertake a systematic review of these procedures. The Interventional Procedures Advisory Committee (IPAC) considered the systematic review and has also produced guidance on: infracoccygeal sacropexy using mesh for vaginal vault prolapse repair, sacrocolpopexy using mesh for vaginal vault prolapse repair, sacrocolpopexy using mesh for uterine prolapse repair and insertion of uterine suspension sling (including sacrohysteropexy) using mesh for uterine prolapse repair.

– Uterine prolapse occurs when the womb (uterus) slips down from its normal position into the vagina. Infracoccygeal sacropexy is an operation that involves the insertion of a piece of material (mesh) with the aim of holding the womb in place.

– Risks and possible problems:

Mesh extrusion requiring further treatment occurred in 4 out of 35 women who had infracoccygeal sacropexy alone and in 6 out of 44 women who had the procedure done together with a hysterectomy. As well as looking at this study, NICE also asked expert advisers for their views. These advisers are clinical specialists in this field of medicine. The advisers said that problems may include mesh extrusion, infections, damage to the bladder, bowel or rectum and painful sexual intercourse. The advisers also said that there may be fewer complications with newer types of mesh. For more information about prolapse of the womb, a good place to find out more may be NHS Choices (www.nhs.uk). Your local patient advice and liaison service (usually known as PALS) may also be able to give you further information and support.

Learning curve and clinical experience
Mid-urethral sling surgery

The surgical duration of TVT surgery is shortened after the operator has performed 15 operations (LE 4) (Ito et al.,2011). Higher rates of complications mainly occur in the first 4 months of training (LE 4) (Maguire et al.,2013).

During the learning phase (50 first MUS procedures), the complication rates (bladder injuries, urinary retention and de novo bladder outlet obstruction symptoms) are higher (Lebret et al.,2001).

Concerning the effect of a learning curve on the success rates (objective and/or subjective cure rates), the published data remain controversial. Cetinel et al.,

(2004) observed comparable outcomes (subjective cure rates) 2 years after MUS procedure, irrespective of surgeon ‘experience’ (< 20 MUS procedures vs > 20 MUS procedures). Koops et al, (2006) reported that, at 2 years follow-up, the outcomes (objective and subjective cure rates) observed following 20 MUS procedures were better than those observed during the 10 first procedures (LE 4). However, at 5 years follow-up, another study observed that subjective

cure rates were not related to the surgical volume of the surgeon who performed the procedures (< 50 procedures vs > 50 procedures) (LE 4) (Holmgren et al.,

2005). Finally, the learning curve for MUS surgery is probably variable (from one trainee to another) and may be longer than expected (learning curves should be individualized).

Numerous confounding variables exist, such as the trainee’s prior experience, the difficulty of procedures and the level/quality of the supervision by a ‘senior surgeon’ (Khan et al.,2014).

Pelvic organ prolapse surgery with meshes Laparoscopic sacral colpopexy This is important for those of you who have complications after Laparascopic surgery.

A laparoscopic sacral colpopexy (LSC) requires the attaining of laparoscopic suturing and knot tying skills. Claerhout et al., (2009) observed that LSC operative duration decreased rapidly during the first 30 procedures and reached a steady state after 90 cases. However, complication rates remained unchanged throughout this learning curve series. Using a cumulative sum approach, they hypothesised that adequate learning occurred after 60 cases (LE 4) (Claerhout, 2009). Akladios et al., (2010) also observed that LSC operation duration decreased after 25 procedures.

The complication rates were also low throughout this series and were not affected by the learning curve. However, this study analyzed the learning curve of a senior urogynecologic surgeon who commenced this technique, and not the learning curve of a trainee. Kantartzis et al., (2013) analysed the learning curvesof the first 180 LSC done by 4 attending urogynecologists and observed that there was no significant difference in the rate of overall complications regardless of the number of prior procedures performed (LE 4).Mustafa et al., (2012) observed that LSC operative time decreased considerably following the first 15 cases (LE 4).

However, since complication rates associated with LSC are low, the published series cannot assess the effect of under-experience since the number of cases is few in each series. Furthermore, the complication rates are probably limited because of the supervision by a ‘senior surgeon’ during this learning curve.

Prior training in laparoscopic suturing coincided with a short learning process for the phases requiring suturing (Claerhout et al.,2014). The most time-consuming step is the dissection of the vault, for which it took the trainee 31 procedures to achieve an operation time comparable to that of the teacher (Claerhout et al.,2014).

The learning curve for robot-assisted sacrocolpopexy (RASC) may be shorter than the learning curve for LSC but there is no precise data concerning this point (Serati et al.,2014).
I know women who were injured because of the malfunction of the robot.

Mesh placed by vagin al route Bafghi et al., (2009) observed that operation duration decreased and then remained stable after 18 procedures.

Concerning the prevalence of vaginal mesh exposure, Guillibert et al.,(2009) observed that women treated by vaginal estrogens and those operated by

the most experienced surgeon had less exposure. However, following multivariate analysis, the only independent risk factors of exposure were the kind of prosthesis, age less than 60 years and concomitant hysterectomy (Guillibert et al.,2009). Achtari et al., (2005) showed that the prevalence of mesh exposure was associated with surgeon experience. Withagen et al., (2011) demonstrated that every ten years of clinical experience reduced the risk for mesh exposure intransvaginal mesh surgery by 50%: clinical and surgical experience was inversely related to the risk of exposure (OR 0.5, 95% CI 0.3– 0.8 per decade). Impact of treatment centre and medical specialty

Concerning mesh use in POP surgery, Rogo-Gupta et al., (2012) showed that intermediate-volume (OR 1.53; 95% CI 1.44-1.62) and high-volume (OR 2.74; 95% CI 2.58-2.92) surgeons are more likely to use mesh than low-volume surgeons. Compared with women who underwent operations performed by gynecologists, those treated by urologists are more than three times more likely to undergo mesh-augmented prolapse
repair (OR 3.36; 95% CI 3.09-3.66).
I must interject here. High volume surgeons are more than likely being paid to use a manufacturer product. You can check this out on a blog I wrote on this subject. http://www.meshangels.com/manufacturer-kickbacks-to-doctors/

Conclusion

There is a learning curve for MUS procedures and for POP surgery procedures, especially concerning operation duration, and the evidence would suggest only experienced surgeons (such as > 20 cases performed under supervision of an experienced surgeon) should perform this kind of surgery unsupervised. The manufacturers will sell implants to ANY hospital administration and then any doctor can do these surgeries.

Mitigating risks through patient selection and counselling

Patient selection

In the case of urogynaecological mesh devices, there is at present very little robust evidence available to inform patient selection when used either for POP or SUI. When considering surgery for SUI in female patients, the evidence stated in the 2014 guidelines of the EAU (EAU, 2014) should be taken into account. Ideally the increasing literature on complications (and by deduction, on successful outcomes for patients) will in the future support a meta-analysis of patient selection for avoiding poor outcomes.

Patient counselling

The informed consent process should be a wide-ranging discussion with the patient regarding her specific situation. This discussion should cover issues such as:

• The patient should be informed that limited robust data is available on the efficacy and safety of many of the transvaginal mesh products available for POP and that particularly long-term follow-up is currently not available which makes a balanced estimate of the risk/benefit ratio difficult. There is considerably more robust evidence on the safety and efficacy of polypropylene mesh use for SUI (RANZCOG, 2013; Nillsson et al.,2013). This is impossible when a doctor is being courted to use a certain manufacturers implant. Salesmen are vigilant in knocking doors to get their implants on the shelves of every hospital in their sales area. You can read how bad it gets by reading this blog I wrote. http://www.meshangels.com/mesh-danger/

• Potential benefits and complications of prolapse surgery in general versus the status quo or using conservative treatments (e.g., pelvic floor exercises or

vaginal pessary). When I went to see my implant doctor I was never offered any solution except surgery. This happens all the time in the U.S.

• Potential benefits and complications of transvaginal mesh specifically when considered appropriate (Table 1 – Table 3).

• Alternatives to surgical management, including non-surgical options such as pelvic floor muscle training (Hagen et al.,2014) and vaginal support pessaries. Surgeons in this country, cannot make money from selling pessaries which is why it is always surgery.

• Other alternative surgical treatments such as conventional native tissue repair, as well as abdominal sacrocolpopexy (open or laparoscopic) in appropriate and certain anatomical and functional circumstances. Sacrocolpopexy is not a general alternative for vaginal mesh implantation. It depends on the anatomic and functional indications and has its own risk/benefit ratio, which in some instances can be more serious and needs to be discussed in the shared decision process with the patient.

Complications of transvaginal mesh including mesh exposure/extrusion, vaginal scarring/stricture, fistula formation, dyspareunia, urinary problems, infection, perforation and/or pelvic pain, which may require additional intervention and may not be completely resolved even with mesh removal. No they may not be resolved but many women won’t have a choice BUT to get it removed due to serious complications. I was one of them. This is why I am highly ANIT MESH. It causes more complications than you ever had in the first place.

• Pain and or dyspareunia caused by prolapse surgery with or without mesh should be discussed based on the available scientific evidence and not on authority-based Opinions. This will NEVER happen in the U.S.

• Provision of written documentation, including device labelling when available. If a mesh procedure is considered, patients should be informed of the following additional issues (Health Canada, 2014): I know a lot of Canadian women screwed up because of mesh and they were never informed. Has this changed? They will have to speak for themselves.

• Through what route the mesh will be placed (abdominal, transvaginal, transperineal).

That a mesh is considered a permanent implant; removal of mesh or correction of mesh-related complications may involve subsequent surgeries. Most women I know who were implanted before the 2011 FDA warning, were never told anything. This to me is a violation by the manufacturer AND the doctor and women pre this warning should be given more money for their settlement. That is my personal opinion.

• That complete removal of mesh may not be possible and additional surgeries may not fully correct some complications. Tell me and the other thousands of women who will have to learn how to live with debilitating complications WITHOUT any support or resources. There should be a fund set up by every manufacturer who continues to push these implants, to pay for future surgeries and non-stop costs of these complications. The U.S government should also pay into this fund because they continue to allow this to happen to thousands upon thousands of women.

• Patients should be encouraged to ask their doctor questions about why he/she thinks that mesh implantation is particularly beneficial for her and what the

evidence or level of experience of the doctor is who is supposed to perform the procedure, as well as what particular risks are involved in the proposed procedure. Yeah right. Like one woman told me, her doctor told her to go home and Google it. Personally after all that has happened to me, if I had to do it all again I would carry a cell phone recorder when I interviewed a doctor. It is too late for me and the learning curve has not only been highly costly financially, but also cost me my future.

Risk assessment and recommendations by National Associations

In 2007 and 2009 (December), the French Nationa lAuthority for Health (Haute Autorité de Santé (HAS)) published information for the public and health professionals, concerning the assessment of meshes used for the treatment of SUI or POP, including the following: 1) the use of polypropylene slings for SUI surgery was approved; 2) the use of polypropylene or polyester meshes for POP surgery by abdominal route was also approved; only macroporous meshes with pore size > 10mm and low grammage of < 150 g/m2should be used); 3) the use of polypropylene meshes for POP surgery by vaginal route was not recommended; (lack of conclusive data concerning side effects and actual efficacy compared to autologous techniques).

In October 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA), which is the competent authority in the UK, published an assessment of the evidence on the benefits and risks of vaginal mesh implants. This document states that the number of reports of serious and debilitating problems following surgical treatment for stress urinary incontinence (SUI) or pelvic organ prolapse (POP) using vaginal mesh implants is low compared to the overall use of these implants. However, there is some evidence of under-reporting to MHRA, which raises some concern about the actual number of problems.

Ladies in the U.K. I do not know how hard it is to report your complications, but somehow you have to find a way because I know how much many of you suffer. Read the next paragraph to understand why you HAVE TO REPORT your complications.

In its report, the MHRA concludes that the overall benefit outweighs the relatively low rate of complications for the use of vaginal mesh implants for SUI. In the case of POP treatment using meshes, the MHRA acknowledges that outcomes are more varied, reflecting the various procedures currently used. On the

whole: “MHRA’s current position is that, for the majority of women, the use of vaginal mesh implants is safe and effective. However, as with all surgery, there is an element of risk to the individual patient” (MHRA, 2014).

In the USA in October 2008, the US Food and Drug Administration (FDA) issued a Public Health Notification (FDA, 2008) regarding vaginal mesh, providing advice for surgeon training and informed consent for patients. Serious complications requiring further surgery were described as “rare”. However, from 2008 to 2010 there was a fivefold increase in adverse event reports to the FDA in relation to the use of vaginal mesh to treat POP. My implant surgery was March 10th 2010. Not ONCE did my surgeon inform me of this warning and I had no clue it was a mesh implant so there was no way for me to learn about this. This happened to many, many women.

The following paragraph mentions the 2011 warning by the FDA. I was so naive back then I thought it was the first warning. I was suffering so much pain at that time and I did not take in all that was going on. I was also foolish to believe at that time that the FDA was going to pull off the shelves all these implants and actually do something. I have had to learn over a long time that this will not happen until thousands more women are injured and left to get on with it, by this government agency. This is why I continue to write and speak out. It is the only way I can give women a chance that this will not happen to them. However, I can’t make them believe me.

In response to the rise in reporting, and following an FDA internal review, including a systematic literature review, a second Safety Update was issued in July 2011 (FDA, 2011). This update states that: 1) “serious adverse events are NOT rare, contrary to what was stated in the 2008 PHN”; and 2) “transvaginally-placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair”. The update made a distinction between the risks associated with abdominal implantation of surgical mesh for pelvic floor repair and vaginal implantation, concluding also that: “There does appear to be an anatomic benefit to anterior repair with mesh augmentation. This anatomic benefit may not result in superior symptomatic outcomes or lower rates of repeat surgery for recurrent prolapse compared to traditional POP repair without mesh”.

FDA committee consultation and further regulatory action were announced by the 2011 publication, and since then the FDA has increased the required post-market surveillance of these devices. Manufactures of urogynaecological mesh devices have also been required to undertake mandatory post-market studies to provide comparative data between mesh kits and conventional surgery. To require a manufacturer to do this is Bullshit. They are NOT the people injured by their products and they are BIASED.

In April 2014, the FDA issued two proposals to address the risks associated with surgical mesh for transvaginal repair of POP. If finalized, the orders would reclassify surgical mesh for transvaginal POP according to FDA’s scheme from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness. As noted by the RANZCOG publication, the FDA conclusions have sparked further debate within the medical and patient community. Further debate will not help the enormous amount of women who will still suffer the consequences of mesh over time. For many women it takes years before they begin the journey of suffering.

In response to these publications and regulatory changes, use of urogynaecological mesh in the USA has declined by 40–60% (Daly et al., 2014). In addition, a number of manufacturers have withdrawn their meshes from the USA market. Are they joking? No these companies were taken over by the largest and greediest of the manufacturers. It has not slowed down ONE BIT.

So now you know that the FDA put out warnings in 2008, 2011 and 2014. This report was written the end of 2015 and you should know that the USA also put out another in February 2016, this year, and you can read my blog. http://www.meshangels.com/the-fda-injured-women/

Health Canada has issued a Health Advisory on 4 February 2010 (Health Canada, 2010), which was revised In March 2013. (Health Canada, 2013, Appendix O) This advisory provides a general statement regarding the potential risks associated with the use of surgical mesh in the repair of POP/SUI. The Advisory notes the increased Canadian and international reports of surgical complications associated with urogynaecological mesh use and requests the reporting of any adverse event associated with this type of device.

In May 2014, Health Canada released two health notices (Health Canada, 2014). The first was a safety information update to hospitals containing recommendations for surgical mesh for POP procedures and SUI procedures. These recommendations included statements regarding the potential for higher rates of complications in transvaginal placement of mesh compared to abdominally placed mesh or native tissue repair. Other recommendations discussed the importance of surgeon training.

A second information notice was released informing patients of the potential risk of complications associated with transvaginal implantation of surgical mesh devices for the treatment of POP and SUI. The latest statement includes the following comment, “The use of transvaginal mesh devices for POP and SUI repair has been associated with reports of acute or chronic pain, pain during sexual intercourse, mesh extrusion and shrinkage, infection, urinary problems, organ or blood vessel perforation, nerve damage, bleeding, vaginal tightness and/or shortening, and recurrent POP and SUI.

Additional surgery may be required and may not fully correct some complications. Health Canada is reviewing labelling related to these products to determine if it provides appropriate safety information. Additional safety information in the labelling will be requested, as needed.”

In Australia, from 2008, the Therapeutic Goods Administration (TGA) has been closely monitoring urogynaecological meshes and has continued to publish information for the public and health professionals. A review of urogynaecological meshes was undertaken

by TGA in 2010. Following this review, a detailed analysis was undertaken in 2013 of the available published literature, the information supplied with each device and associated training materials provided by sponsors and manufacturers.

The Urogynaecological Devices Working Group (established under the Advisory Committee on the Safety of Medical Devices) provided expert advice to the TGA on this review. As part of the review, the TGA undertook a literature search of materials published since 2009. The overall quality of the

literature was found to be poor. As a consequence, there was an absence of evidence to support the overall effectiveness of these surgical meshes as a class of products. However, the literature did identify the already known adverse outcomes associated with their use.

The TGA review identified inadequate training/experience for surgeons doing the implantations as a factor in increasing the risk of complications. Certain patients, including those who smoked or were obese, were found to be at higher risk of adverse events and repeated procedures. I have to tell you something that TRULY pisses me off. The business of blaming women for their weight. Every woman I know who have had these implant surgeries with complications WILL GAIN MORE WEIGHT, because of the difficulties of pain and nerve injury. Before the implant I was up and down ladders and scaffolds all day, working on my house. After implantation, I could not raise my right leg 4″ high without extreme agony in my groin and NO it HAS NOT gone away.

As a result of that review, which has raised a number of concerns, the TGA is currently reassessing the clinical evidence for each individual mesh implant to determine if they comply with the Essential Principles, which set out the requirements for safety and performance necessary for inclusion on the Australian Register of Therapeutic Goods (ARTG). While all these organizations access these implants, thousands more women are living in pain with MAJOR complications and doctors walk away from them every day, refusing to believe them while offering no help at all.

Where individual meshes are found to be noncompliant, regulatory action, such as cancellation or suspension of particular devices from the Australian Register of Therapeutic Goods (ARTG), will be pursued.

This is an extremely long report and following this more about risks and identification of high risk patients. In this country, I don’t think any doctor pays any attention to high risk patients because they will put mesh in anyone including women with M.S or other wheelchair diseases. I know because I have been contacted by these women.


Identification of high risk patient groups

Are there patients groups (e.g. in relation to age, weight or other comorbidities) for which the use of meshes would carry a specific risk? (Q7) Yes. The SCENIHR acknowledges the importance of the identification of high-risk patient groups. Age and obesity have been shown to be associated with increased risk of mesh exposure. This should be investigated further.

In the light of the above, identify risks associated with use(s) of meshes other than for urogynecological surgery and advise if further assessment in this field(s) is needed. (Q8) The SCENIHR notes there is limited information in the literature on this subject. There is a suggestion that morbidity may be associated with colorectal use of meshes. This needs to be quantified by further research before any conclusion can be made.

Recommendations

• Ensure that patients are correctly and comprehensively informed relating to the performance and risks associated with synthetic non-absorbable meshes

•Establish European implant registries

• Establish scientific studies to assess the long-term (at least 5 years) safety and performance of synthetic non-absorbable meshes This needs to be lifetime
study to get the true facts of what these implants do in a woman’s body.

• Support further research into novel new materials, in particular absorbable meshes Who will be the guinea pigs of new meshes? Who will suffer the consequences? Doctors did not believe all the complications from animal studies so they began putting them in women. This is why this has happened to the women of the World.

• Support further research into the application of regenerative medicine technology, such as the cellular seeding of graft materials

• Adopt evidence based Pan-European Guidelines

• Develop training programs for surgeons in association with European medical associations

They also held a public meeting and you can read all about that on this report.

So how do I feel after reading and editing this report for you to read? It took me many hours to try to make it easier for injured women to read and slowly take in because I am aware that when you live in pain, you have good and bad days, when you can’t take anything in. I also know many women have brain fog and it is really difficult. This is the most comprehensive report I have ever read and I learned so much by reading it. It told me many things I did not know, including every type of mesh and surgeries, some of which I was not aware of before I read it.

I always have difficult in reading these reports because the people who are doing these surgeries have NO IDEA what it is like to live PERMANENTLY with complications from these implants and surgeries. They go on with their lives without thinking of the women themselves. I can’t because I have not only lived this horror story and still do, but I get to know the women themselves and know what this has done to many, many lives.

The FDA could learn a thing or two from the Europeans. The way this report was written is extremely well done. Whatever they wrote about was backed up by the articles right beside the issues they mentioned. The FDA’s report was nowhere as good for anyone who wanted to research more. Any papers written were added at the end without any explanation of what the paper was about. This means of writing a report is the correct way to do it.

I loved the in-depth way that this report tackles just about everything in the past and now. Yes it is extremely involved but I know many brilliant women who have lost their careers because of these implants and they will glean something more from this report. I also know many women who were once in the medical field who will appreciate and understand much of it. Nurses, R. N’s, nurse practitioners and many in other fields of medicine. These complications affect all women, regardless of status or career. It tears many women down below the poverty line and no one cares.

Every woman will learn something from this report, regardless of where you live. It is well worth taking the time to slowly comprehend while you read it, perhaps more than one.

You can now read a lot more on the subject of mesh if you continue reading by going to the direct link and see many charts. It is 105 pages long.
This is the link. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_049.pdf

2 Responses

  1. Margaret Carty
    | Reply

    Great informative and well written. My Story….I attended gynecologist 2016 for routine pap smear and casually mentioned I suffered from USI. His head popped up like a ‘Jack in the Box’ from between my legs “I can fix your Usi”. When I said I didn’t want to have unnecessary surgery, he said my USI would get worse and promised surgery would greatly improve my quality of life. In hindsight he played on my fears and sugar coated the procedure, said it was a safe, straight forward, minimally invasive, effective and uncomplicated procedure. Furthermore he never discussed the risks and complications, or that the tape was a synthetic mesh implant. or that it was permanent. To the contrary the outcome of my surgery indicates that it was unsafe, very invasive, and extremely complicated. . Nevertheless I Went into hospital a very young 60 year old, fit, active, independent and loving life, Yet I came out ‘BROKEN’. a physical and mental wreck. (“One Flew Over the Cookoo’s Nest”). In other words I was put at risk and my safety compromised in a sub-standard procedure. This occurred because when my gynecologist realized I had no private health cover he refused to do it in his private rooms but said “I do the same procedure in xxx and I will do it there”. I believed him and went public as his recommendation, yet he still assured me he was my surgeon. However I awoke from surgery with significant adverse surgical injuries. A strange doctor appeared and told me she did my surgery and perforated my bladder. She didnt tell me that she misplaced the TVT first time and it had to be done again which left me with 4 pelvic wounds and severe bruising and swelling. I believe she was an inexperienced surgeon who did not have the skill or technique to deal with the complexities of TVT surgery, As a result today I suffer pain and Femoral Nerve Damage and bladder dysfunction includes…urgency, frequency, hesitancy. In addition I must stand when voiding and force voiding because when I sit NOTHING, the flows stops. Furthermore my USI has returned with a vengence and I now need protection 24/7. Yet I received no explanation for my injuries or slow progress. I feel that I was used as a guinea pig in an experiment to be butchered bruised and battered. and coincidentally when the surgery didn’t go according to plan and I needed answers my gynecologist refused to see me or address my concerns. When I finally saw him two months later he dismissed my ongoing symptoms as trivia and offered no follow up treatment. Since this surgery I struggle every day with pain, discomfort anxiety and bladder problems. I’ve lost my dignity, and independence as I depend on others to do even simple tasks like household chores. In addition I was a champion dancer but now I am devastated that I can no longer dance. Even more distressing my entire family are traumatized because they are heart- broken seeing me suffer especially when they recall how active I was before surgery. I feel lost and guilty not tending to them or being able to pick up my grandchild. How do I explain that to a two year old? Furthermore unable to have sex due to discomfort and fear of penetration is effecting my marriage. I also miss the gym, work, gardening, bush walking and being with active friends who have moved on as I cannot keep up. I am in despair because my life is in a mess as I struggle to cope with debilitating and catastrophic ongoing problems and yet my surgeon said in my discharge papers which I only received yesterday. “She is pleased she had the surgery. “HOW DARE HE” speak for me as I never said any such thing. In his arrogance and egotistic mind this is what he wants to believe but is far from the truth. My GP said I should make a formal complaint but it is in the hospitals interest to defend their doctors so I doubt they will believe me. In addition I was told’ my surgeon went in there blind’. But surly to use the term blind and surgery in the same sentence is an insult to common sense and so called modern medicine. Yet TVT surgery is not modern medicine because it destroys lives. I conclude ‘TVT’ surgery is savage, cruel and barbaric.

    • Linda
      | Reply

      Margaret I wish I could say your story was unusual, but it isn’t. Unfortunately arrogant doctors believe they KNOW what they are doing, regardless of the damage they cause. I wrote a blog about it being a blind procedure. http://www.meshangels.com/surgeons-blind-dangerous/

      I am going to email you, if your email address works.

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