Recall

  1. Does anyone remember a recall of Ethicon Vicryl sutures in the mid 1990's?

    I found some info on the FDA home page, but would like to know if any of you remember this and what was the recall regarding.

    Thanks
    Nicole, OBT
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  2. 5 Comments

  3. by   P_RN
    http://www.hideintl.org/1-suture.htm

    I just drifted in here looking for info about the scrub nurse pouring meds and saw this thread. I do rmember us having to pull all the Vicryl maybe two different times?
    Like 1990 and maybe 95?
  4. by   nograd
    Thanks for the info

    I have worked in L&D for a while now and have never heard of a suture recall and all we use are Ethicon Vicryl, Chromic and PDS... I was kinda shocked when I saw all of these recalls and I never heard a thing about them...Maby they were caught before and pulled by the suture rep and I never heard a word about it (I work nights)

    A friend of mine had some complications following a surgery back in the mid nineties and the surgeon used Vicryl sutures...she asked be about it knowing that I scrub and I had no recollition of any recalls. Thankfully everthing has turned out ok.

    Thanks again,
    Nicole OBT
  5. by   lafontenot
    I see that this post is old, and hope my replying to it will still reach some. My name is L.A. and I am one of the victims of the contaminated sutures Ethicon recalled --- from one of the recalls in the mid 90's as refered to above. I and several others were involved in a class action lawsuit with Johnson & Johnson/Ethicon Inc. that was settled out of court this year. Although I cannot discuss certain things, I can discuss any information I know to be a matter of public knowledge, and my personal struggle. I had a lingering Staph infection in both breast for over 4 years (reduction mammoplasty done in june 98). I had complications and illness that baffled even the best of doctors . My sutures spit out everywhere and did not dissovle, and I developed chronic pain and have deformity and chronic swelling still --worse in my right breast.
    I am taking the time to post this because this is still happening. There was another massive recall of sutures in 2001 , of over 1 million sutures ... AGAIN. ****see info on this at **** www.crestnetonline.com/elerts/apr3001.htm
    The things I know, the stories I have read, the pain and suffering and torment my family and I have undergone is so tremendous. If there is anyway my story can help others or educate or do anything , I pray it will be done. Take care to all of you wonderful nurses and thanks for letting me post. LA
  6. by   ggmamk
    I found this forum through Google. I, too, was a lucky recipient of the contaminated sutures and received a very small settlement considering the pain and changes the infection made in my life. I received the sutures during a tram flap reconstruction after breast cancer. I had problems healing initially, but the abscess and infections were about 18 months later. After a month on IV antibiotics the surgeon opened my abdominal wall to find two sutures that were infected. He removed the sutures and carefully cleaned the area. I went home with IV antibiotics once again. About a month later when the IV was removed the infection returned. I was again put on IV antibiotics for another three months off and on. Finally the Plastic surgeon and a general surgeon removed all the infected mess, including all my abdominal muscles. Hip to hip breast to pelvis, I have no muscles at all, just the outer skin over the entire abdomen with nothing holding in my organs and bowels. I have worn binders for eight years now. I wear as many as four at a time for support. My skin stretches more all the time. I cannot walk or stand for longer than a few minutes without having to sit. I was in the hospital again last week with pain and the CT scan showed some inflammatory tissue around my colon. IV antibiotics once again helped. But the pain continues. The surgeon told me I can never have surgery because nothing would hold the sutures in place. He told me all my organs are falling out of place and the pain is most likely due to that. He wants me to lose weight. I have gained nearly 100 lbs since the surgery removing the muscles because I can't burn off calories. I am now diabetic, also. I am so tired of looking and feeling like I am nine months pregnant at nearly 70 years of age. My reason for adding my story here is because I am so angry that Ethicon got away with this. No doctor or nurse has ever heard of these sutures when I tell them. If a good friend had not been watching 20/20 when this was discussed I would have had no idea what happened to me. The small settlement I got was based on the fact that my surgery was two years after the supposed recall yet today these sutures are showing up in Iraq in our soldiers. They were packaged not only under Ethicon labels but sent to other companies who sold under their own labels. Wendy York is a lawyer in CA who has been active in pursuing this injustice. Thanks for listening.
    Last edit by ggmamk on Feb 8, '08 : Reason: typo
  7. by   appleuvhisi
    my name is linda. i had a partial vulvectomy in 1997 and i was sewn with vicryl 3.0 sutures. shortly after the surgery, i began having intense burning in the vulva area. i knew i was not dissolving the sutures so i returned to the clinic to see the doctor who performed the surgery. his words to me were, "what do you want me to do, go in and dig them all out?" he told me that time should take care of the problem, he sent me home. i continued having severe burning 24/7 and could not find anyone who could help me. i would have repeated infections that seemed to cycle. finally, in 2003 (i was about ready to end my life) i found a gyn who listened to the torment i was suffering. he examined me, and told me that i should be hospitalized and have the burning irritated suture areas cauterized. so, i gladly did, however, they continued to surface. by this time there was no actual suture. it is my doctors opinion that the suture broke up into microscopic pieces like "shrapnel" and they were crystallized. these microscopic pieces are causing "tunnels" in my vulva. they erupt and resemble "fang bites", one on each side of the incision line. they burn so bad and the pain radiates into my thighs and pelvic bone. there are times, they feel like glass. i have had to date, 81 cauterizations to my vulva to remove these microscopic pieces. i am burned at 2400 degrees wide awake. i have and continue to be tortured beyond comprehension. i was 38 years old when i had this surgery and i am now 52. i have had no intercourse with my husband in all of these years. i spend all of my time getting burned and laying in a bed at home trying to heal and battling one infection after another. i lay with ice packs and pain meds, which do nothing more than depress me even more. my doctor tells me that there is no way of knowing how many of these tiny bit of sutures there are. it seems there is no end in sight.

    in 2007, i posted an article on line asking if anyone had a problem similar to mine. a journalist contacted me and informed me that there was a class action law suit against johnson & johnson, ethicon in 1999. she recommended that i find out what kind of suture was used for my surgery. my gyn sent for the op report and found that i was sewn with vicryl 3.0 sutures. i spent all of these years suffering from sutures that were not fit for anyone or anything! my life has been destroyed!!! i contacted an attorney and was told that i am past the statue of limitations. how can that be, when i never was notified of the class action suit or that the sutures were no good? i live my life laying in my bed. i can not walk without pain. when i urinate or have a bowel movement, i cry. i can not stand clothing or underwear against my skin. i can not sit. i do not drive. i am ruined.. for the life of me, i do not know how the manufacturers of these vicryl sutures can get away with this. they knew there was a problem and they did not care. i can not even think straight most of the time because of the anxiety from the constant pain and burning!!!!!! my husband has stood by and watched me suffer every second i breathe. my entire family feels helpless have all been affected by this nightmare. it is all from someone's greed and lack of care for human life. god forgive them. i would like to speak with another victim of this. i do not know if anyone will stumble on to this or not, but if you are one of us or have had a problem with these sutures, please e-mail me
    kokoe@twcny.rr.com thank you so much...

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