Johnson & Johnson Suture Recall Issued Over Sterility Concerns

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Ethicon, a subsidiary of Johnson & Johnson, has pulled more than 100 batches of medical sutures which may not be sterile, continuing a string of recalls that has haunted the medical device and pharmaceutical giant for more than a year. 

The Johnson & Johnson suture recall was originally announced in a Field Safety Notice by Ethicon in late December to distributors, but did not go public until the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) posted an alert on its website earlier this week.

The sutures are being recalled because of defective packaging seals on the individually wrapped suture strands, which could leave them open to contamination. The use of non-sterile sutures could cause a patient to suffer a hospital infection. There have been no adverse events reported in connection with the suture recall.

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The recall affects about 585,000 individual suture strands, mostly distributed throughout Europe. None were shipped to the United States. The sutures were sold under the brand names of Ethilon, Ethibond, Mersilene and Mersilk.

The secretive nature of the recall by Johnson & Johnson raised questions from some critics, who were already concerned over alleged prior attempts to cover-up recalls in the United States. In late 2008, Johnson & Johnson conducted a “phantom recall” of Motrin that was dissolving properly. The company allegedly hired contractors to buy back Motrin from stores without telling the store owners, the public or the FDA that there was a recall until 2010.

Johnson & Johnson has denied a cover-up in either recall, saying that regulators were notified about the suture recall and that the public was not alerted because the sutures were quickly pulled from the market.

The charges of the so-called ‘phantom recall’ first came up at a Congressional hearing last year after a massive Johnson & Johnson children’s medication recall issued on April 30 that affected 40 different liquid medications, including Motrin, Tylenol, Benadryl and Zyrtec. The company’s actions have led congress to consider giving the FDA expanded drug regulatory powers.

Last month the state of Oregon filed a fraud lawsuit against Johnson & Johnson over the Motrin recall. The Oregon lawsuit charges the drug maker with violating the state’s Unlawful Trade Practices Act (UTPA) on several counts, such as employing unconscionable tactics, making false or misleading representations and failing to disclose certain information. The counts carry a maximum penalty of $25,000 each.

The complaint is just the latest claim filed against the company over recalls in 2010. At least two other Johnson & Johnson class action lawsuits have been filed, accusing the company of fraud and racketeering.

Tags: Ethicon, Hospital Infection, Johnson & Johnson, Medical Device

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18 Comments

  1. William

    I’ve had 6 post op infections since my knee replacement in Dec. 2010. All of them were located on ETHIBOND sutures.

    Thanks, Johnson & Johnson.

  2. Rhoda

    I had Ethibond sutures that caused amassive sinus tract infection needing a second surgery to remove the suture. I endured daily gauze packings for a month. I am left with massive scars. I do not know how this keeps happening in the US. Even MD’s in Malaysia knew of the recall! Who is the FDA helping-us or the companies?

  3. Linda

    My husband had rotator cuff surgery in August of 2009. He ended up with five more surgeries after original one. He developed a horrible infection that kept coming back, from the inside out. His sutures were Vicryl Plus sutures. Having a hard time finding a law firm to take on J&J. Live in Arkansas. Attorneys here do not have enough capitol to go up against J&J.

  4. Lee

    I had Achilles Tendon Surgery in May of 2012 and I am still having stitch rejection as of May 2013. I have had 2 surgeries and the doctor has thought that the infection was MRSA since the signs are similar with the Sinus Tract infection that it turned out to be. I have been in constant pain, on antibiotics for a month, depressed and confused until the connection with the issue of the Ethibond Sutures causing this sinus tract infection. I go back into the wound care center today to have the stitch taken out for the 3rd time! It has cost me over 15 trips to the doctors office which is 60miles away and of course the scarring and confusion with the healing process. I would like very much to join any active litigation on resolving this issue

  5. Kim

    My 17 yr old daughter had surgery in Nov 2013. Within a month, the incision line was seeping, blistering, swelling, causing pain and horrible itching. Dr. said she is allergic to the vicryl stitches. Getting worse, infection has spread to other foot and now saying its a dermatisits thing, not the stiches at all. I KNOW BETTER, which led me to googling info which led me here. How the hell do I help her now? We don’t have money for more surgery. Lousy insurance and now Dr’s saying its not the stiches, its her body reacting to them and this kind of reaction isn’t common at all. OMG. I don’t want to see anyone suffer but especially not my daughter. Is anyone getting help here?

  6. Bre

    I have been having a reaction to monocryl absorbable sutures with 6 additional surgeries same problems undissolved sutures, chronic inflammation, & infection. I live in Ga, I am having a hard time finding an attorney too take on J&J can anyone please offer some suggestions on litigation.
    Thank You

  7. Greg

    I had a ruptured right side pectoralis major repair (back in 2008) that they utilized Vicryl and Ethibond, both mono and poly fillimanent sutures. I had had 3 additional surgeries to remove infected sutures that were purging out of the original (2008) surgical site; even protruding out through the skin in the surgical site. I now (was just at the surgeons office this morning) have another infection caused by remaining sutures, and had to endure severe pain, financial and emotional hardship, as well as intermittin employment/ income due to continuous and ongoing problems/ complications with these multiple surgeries stemming from these known brand of recalled sutures. This problem started to arise about 19 months after the original repair in 2008 and has been an ongoing problem for a total of 6 years after original surgery!… My last surgery for this was only 6 weeks ago

  8. teldia

    I had a transvaginal hysterectomy in 1996 and ended up having a whole hysterectomy in 2000 because the sutures they used the first time caused so much infections and the cyst got so bad it’s messed my whole life up thxs for the warning I never got wish I had my life back

  9. George

    I’ve just had surgery to remove infected ethibond sutures and nots in my shoulder. Have been on two antibiotics twice a day for a month. I had infection in 2012 with three Surgerys and a PICC line for three months.

  10. Nicole

    I have had a cystocele surgery in November 2013, where 2 sets of Ethibond thread were used for the suture, and have had infections since. My surgeon told me “you are allergic to Ethibond”. From what I read here, I am not the problem.
    A year later, 2nd surgery…the same surgeon did a “repair”.
    He decided to remove one set of thread who he said was probably the problem.
    Well, not…. with one set of Ethibond thread remaining in me, beginning of May 2015, I still have infections and some bleeding…. 18 months !!!!! after the initial surgery.

  11. Johnnie

    I had a colon surgery in Nov 2006 that cause me to become total disabled. Seemly something saw left in my lower abdomen. Later I learn that there was a 2006 Surgeries suture recall. I need information on this recall. I am grateful for information from anyone.

  12. Gail

    I have pain in my groin sharp shooting pain around my tailbone

  13. Katrina

    Responding to Gail’s comment, I also have sharp shooting pain in my groin also!

  14. Edwina

    I had a hiatal hernia repair using ethibond suture and developed H pylori and infection a month after my hernia repair I still suffer with stomach pain hernia moving to my esophagus and bloating and constipation and gas but since the recall for ethibond suture was only in the UK I don’t know if I can do anything about it, no matter if i lose weight my stomach still bloated with constsnce pain I have tried gasrelief ,laxative and herbal remedies nothing helps

  15. Kathy

    My dad had surgery 14 years ago (chest, for Mystenia Gravis) and all the sutures are still there and causing him a lot of problems. No doctor seemed to know what could be done. (Odd) They told him to possibly see a cosmetic surgeon. It looks so bad, almost keloid looking with occasional pus oozing, pain and itching.

  16. Terri

    I’ve had numerous surgeries from 2006 to 2015. They used Vicryl sutures also. I’ve been in pain and have had a lot of the same issues that other people have had. Now i am losing my teeth. They are just falling out or breaking off. I’m not sure how this is happening and why this company can get away with this for so many years. There has to be something that can be done. They need to take those off the market. This is crazy. I too want my life back.

  17. Magnolia

    I had surgery on my left side of my face cheek area. I had a Lipoma growth, it grew within three weeks. I had to have it removed, now the sutures the doctor use was Monocryl 5-0 (Ethicon brand). The doctor put them inside and out on my left cheek, back in March 2016. Since then, I had to have another surgery almost two years later, to get them removed. Well the sutures were in my face, I developed bad inflammation, pus, redness, razor sharp stabbing pain, twitching, feel like ants crawling from my surgery area. All on the my left side of my face, nerve damage, trigeminal neuralgia, hemifascial spasm. It has been three years later, and I am getting worse .Please, tell why there isn’t any class action lawsuit against this company? We are all still suffering with these horrible sutures, that caused all of this damage to us. There has to be an attorney out there, that can help us all.

  18. Deborah

    Had 2 surgeries in Dec 99 and May 2000. Mercelin and Ethicon Vicryl sutures used. Massive infection, granuloma of pelvic area of surgery, abscesses, lost bladder because of it. The mercelin operation (face) ended up with huge abscess that had to be drained surgically. Problems reoccurred 10 years later in the pelvic area—there were still “absorbable” sutures there that had to be removed as well as permanent sutures that had migrated from original position and were puncturing organs. 5 hospitals, 16 surgeries—permanent disability.

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