Johnson & Johnson Suture Recall

Johnson & Johnson Suture Recall


I don’t know anything about sutures, but found this image. If you know any nurses or nurse practitioners, ask them for help. Maybe they can sort it out for you after you read your operative reports.

I received a not from a woman who recently had surgery and her doctor found something very disturbing which involved a suture. So she asked me if she could sue J & J because of it. I had no idea which they were so I did a search. I found a download about the recalled sutures and I am going to give you the first paragraph.

URGENT: FIELD SAFETY NOTICE ETHICON VICRYL™ Suture Product Codes JV7549 & V549G

April 14, 2015

Dear Operating Room Supervisors, Materials Management Personnel and Chief of Surgery: ETHICON has initiated a voluntary recall for select lots of ETHICON VICRYL™ Suture Product Codes JV7549 and V549G (size 9-0 (M0.3)).

The sutures provided in these product codes are labeled to contain braided sutures however they may contain braided or monofilament sutures. This voluntary product recall is being executed because the use of a monofilament suture labeled as a braided suture could impact the tissue handling expectations, knot tying capabilities and tissue closure tension which may present a clinical risk.

EFFECTIVE IMMEDIATELY – DO NOT USE PRODUCT CODES JV7549 and V549G WITH PRODUCT LOTS NOTED BELOW: Device Name Product Code Product Lot Affected Expiry Date ETHICON VICRYL™ Suture size 9-0 (M0.3) JV7549 HG5JBMN June 2019 HG5JBMN5 June 2019 HM5CGMN December 2019 E THICON VICRYL ™ Suture size 9-0 (M0.3) V549G HM5BJLN December 2019

Please see Attachment A for a Product Identification Tool to assist in identifying the impacted lots of product using package labels. PLEASE NOTE: This recall involves only the specified lots listed above of ETHICON VICRYL™ Suture Product Codes JV7549 & V549G. No other product lots are affected. The voluntary recall has been communicated to the European Competent Authorities in the countries affected by this product recall.

ETHICON has received no reports of adverse events associated with the recalled product.

I had no clue about any of this but it seems there have been problems for a long time. I actually read about problems stemming from 2007 so it could be much longer. I did find a Reuters News report from March 2nd 2011. So I suggest any surgeries you have had over the past ten years or so, get your operative reports and nursing notes from every surgery and study them. Here is that report for you to read.

Latest J&J recall involves sterility-risk sutures

Johnson & Johnson, which has been plagued by repeated recalls of its consumer medicines and medical devices over the past year, on Wednesday said it recalled 107 batches of surgical sutures in December due to potential sterility problems.

The recall came to light on Wednesday after the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) described the action on the agency’s website.

The diversified healthcare company said the voluntary recall took place mostly in Europe and involved a total of 585,000 individual strands of sutures. The action stemmed from potentially faulty packaging seals on the individually wrapped sutures that raised a contamination risk, J&J said.

The potential problem was caused by modifications of manufacturing equipment and has been corrected, said Barbara Montresor, a spokeswoman for J&J’s Ethicon surgical products division.

“The company has not received any reports of adverse events related to these occurrences,” she said, noting that none of the sutures were distributed in the United States.

The sutures were sold under the brand names Ethilon, Ethibond, Mersilene and Mersilk.

Montresor said J&J immediately notified regulators of the December 29 recall. Asked why the public was not notified, she said largely because the affected sutures were quickly isolated and withdrawn from the market.

The recall came to light on Wednesday after the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) described the action on the agency’s website.

The Ethicon unit last month disclosed it had recalled a hernia repair product whose packaging was also deemed prone to contamination, as well as 700,000 vials of a liquid wound sealant due to reports some were discolored.

Only days earlier, J&J said it was recalling 70,000 syringes of its Invega Sustenna anti-psychotic medicine because of cracks found in the syringes.

Those actions followed repeated recalls of Tylenol, Motrin, Rolaids and other widely used J&J consumer medicines due to quality control lapses. The recalls, involving hundreds of millions of packages, badly tarnished the company’s reputation and cost J&J almost $1 billion in lost sales in 2010.

Continuing shortages of the products will also crimp J&J’s revenue and earnings in 2011, as the company continues to upgrade deficient factories.

Company Chief Executive Officer William Weldon has said he expects all the consumer products to return to store shelves this year.

I found even more on an older post, dated January 1st 2005 and here it is.

Citizens’ Group Calls for Awareness: Sutures Suspected in Post-Operative Infections

Updated On January 1, 2005 Written By Trudy Peskett


When 26-year-old Carole Carter had surgery in 1998, she never suspected she would be battling an unusual post-operative infection three years later. But the painful, oozing wound on her leg wouldn’t heal, even with repeated oral and topical antibiotics, and Dettol dressings.

About two per cent of people get post-operative wound infections, almost all of which are treatable, according to microbiologist Dr. Tony Mazzulli at Toronto’s Mt. Sinai Hospital. But in this particular case, even specialists couldn’t figure out what was wrong. As for Carole, she only wanted her life back. “I just find it really gross,” she told the Ottawa Citizen about her injury. “It looks like ground beef.”

Seeking answers, Carole’s mother, Robin Carter, began researching via the Internet. She discovered similarities between Carole’s case and American reports of people claiming to have received contaminated sutures. In 1994, about 3.6 million sutures were recalled by Ethicon, the largest suture manufacturer in North America and a US subsidiary of Johnson & Johnson; this resulted in a multitude of lawsuits from people who blamed their infections on tainted sutures. Carole got tested and discovered she had the same rare bacterium, called Mycobacterium fortuitum, as some of these victims.

Mycobacterium is undetectable by routine hospital tests; a specific test must be conducted, which is often why these infections go untreated. “If you don’t know to look for it, you would never know it’s there,” says Dr. Rebecca Irvine in a phone interview. Dr. Irvine, a medical examiner, pathologist and professor at the University of New Mexico, became interested in the issue of suture contamination when her father experienced a non-healing abdominal wound following surgery. After he later died in a car accident, it was discovered that he, too, tested positive for mycobacterium.

“Most wounds will heal by themselves, but these don’t,” she says. Other symptoms include inflammation and oozing discharge that may continue for months, even years. Once discovered, antibiotics specific to mycobacterium are the conventional treatment.

Sometimes surgical removal of the infection is necessary.

The Carters believe Carole received contaminated sutures, although Ethicon has refuted the possibility. But in June 1998 five months after Carole’s surgery Ethicon released a recall notice of 3,076 PDS II sutures, some of which the company says went to a Calgary hospital. However, because suture batch and box numbers aren’t marked on surgery reports, it’s nearly impossible to confirm this connection for Carole and others who have lingering questions.

Carole now recovered physically but still suffering mental and emotional upset as a result of her ordeal belongs to Canadian Suture Victims, a group of Canadians who believe they may have been affected by contaminated sutures. Since Robin formed the group two years ago, some 70 individuals have contacted her, and she believes there are probably more out there. Many people might not know they’re at risk.

In 2001, Johnson & Johnson issued yet another recall notice for 1.1 million sutures Vicryl, Monocryl and PDS II 42,000 of which were sent to Canada. It is unclear how many were shipped back.

In a recall, following a letter of notice, unused product is pulled off the shelves and returned to the company. However, the procedure appears to be far from 100 per cent efficient. For example, according to the US Food and Drug Administration, only 25 per cent of those sutures recalled in 1994 were ever recovered. It is conceivable that many were unwittingly used in surgeries.

“I do think this is a serious problem,” Dr. Irvine says. “The recalls should have been dealt with a lot more seriously. Even if there is only a possibility of contamination, with things like sutures, you just can’t take risks.”

Robin suggests that having physicians mark on surgery reports which batch and box number of sutures were used would not only reduce the risk of using recalled sutures, but would also track the connection between sutures and their source of manufacture. At present, Canadian Suture Victims is exploring issues of legality.

For more information, contact Robin Carter at Canadian Suture Victims at 613-820-5166. Web site for the US-based Ethicon Suture Victims group: suturevictims.com.


It seems most of them were sold in Europe particularly the U.K and Canada and because many women from the U.K read my blog I think it is very wise to read all you can. This Wall Street report will tell you more. http://blogs.wsj.com/health/2011/03/02/jj-recall-watch-ethicon-recalls-104-batches-of-sutures/

Were there any sold in the U.S? I think it is wise to first find out all you can by reading your operative reports.

All the suture recall numbers are on the FDA site and this is that link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&event_id=51049 If you have any concerns please send them an email and check anything you find on your operative reports.

4 Responses

  1. carlotta Owens
    | Reply

    Hello. I had breast reduction surgery on Oct. 31,2008.
    I had vycril sutures.
    I ended up with mycobacteria fortuitum.
    I was on bactrum and cipro for 2 years along with picc lines for antibiotics.
    Im very scarred and still hurts, I cant wear a bra properly.It is a reminder everyday of that surgery.
    I was told I can sue because of medical after 2 years but I could sue because of the product.
    I just want to be fixed from pain, fixed from appearance and get my self esteem back.
    I don’t know what to do. Attorneys wont even talk to me because there not familiar with it.

    • Shea Bee
      | Reply

      Hi. Did you ever get any help with this?

  2. April
    | Reply

    I had a diskectomy at the end of Sept 2016, here it is almost March 2017, I’ve had pain, extreme itching around the incision and the bottom of it has never closed. There are 2 small holes I’d say about the size of the eraser on the end of a pencil. This was my first ever surgery and bc of that had my wife take pictures often of my wound post surgery-today. Less now but, probably once a week or so, so I can see how it’s healing. The majority of the wound healed pretty quickly, at least on the surface, except the areas mentioned above. I’ve brought it up the doctors several times being worried about infection ( I used to work as a CNA and dealt with many patients with MRSA and Staphylococcus infections). So, being educated on the subjects it was always in the back of my mind. Every time it was, “well it’s not oozing, I think you’re fine” my last appointment I brought up again that it wasn’t healed and that my skin surrounding it is very irritated, itches so bad that I’ve made scabs scratching in my sleep. I also asked him why it looked black inside of the small hole, he said it was probably a stitch, asked if I smoked and blamed it in that. He did say hes going schedule me for another MRI and a nerve conduction test, bc I still have pain in my leg and lower back and have to use a cane often. I’m wondering now, and looking back on early post op pics if I’m not having a reaction or am rejecting the sutures and if this is what was used on me? I’m going to be contacting the doctor soon to inquire what kind of sutures were used. Thanks for hearing my story- April

  3. vanessa ross
    | Reply

    I had a umbilical hernia repair in 2011 and ethibond suture was used.It is 2017 and i have had to to have 2 more hernia repairs again.

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