Johnson & Johnson was the first medical device manufacturing company to follow Boston Medical’s example and introduce a second transvaginal mesh device aimed at treating pelvic organ prolapse. Although surgical mesh was originally designed for hernia repair procedures, over the years, companies like Johnson & Johnson have sold hundreds of thousands of surgical mesh devices implanted transvaginally to support prolapsed organs. Under the subsidiary Ethicon, Inc., Johnson & Johnson manufactured and sold several vaginal mesh devices including:

  • Gynecare TVT
  • Gynecare Secur
  • Gynecare Prosima
  • Gynecare Prolift
  • Gynecare Prolift +M

Surgical Mesh Surgery vs. Non-Mesh Surgery

Implanting a surgical mesh in a pelvic organ prolapse or stress urinary incontinence procedure was believed to have better results as the vaginal sling could function as a support system. But following a thorough review of the available medical literature on mesh use in urogynecological operations, the FDA stated that there was no evidence to suggest that a mesh implant surgery are better than non-mesh procedures. Traditional non-mesh surgeries does not pose the risk of mesh-related complications that occur in 10 to 20 percent of transvaginal mesh sling surgeries, while providing the same symptomatic results.

Vaginal Mesh Implant Failure

A significant number of the adverse events reported to the FDA regarding pelvic mesh implants are due to mesh erosion or contraction. Mesh erosion through the vaginal tissue can cause pain, bleeding and infection. In addition, most surgical mesh are made of polypropylene, a material that can shrink after being implanted, causing serious side effects and the POP or SUI condition to return. Symptoms of vaginal sling failure include:

  • Urinary incontinence
  • Abdominal pain
  • Pelvic pain
  • Pain during sexual intercourse
  • Bleeding

FDA Warning and Manufacturer Liability

Due to the findings in the medical literature review, the FDA cautioned patients and healthcare provider against using vaginal mesh devices to treat POP and SUI. In the event of either a mesh contraction or erosion, it is frequently necessary to conduct revision surgeries to remove the device from the pelvic region, but even with multiple surgeries, the device may not always be completely removed. While the FDA may have granted Johnson & Johnson clearance to sell the Gynecare devices the manufacturing company is still responsible to ensure the safety and effectiveness for their products. Women who have been a victim of Johnson & Johnson mesh failure may be capable of recovering damages related to their injuries and permanent disfigurement.

Johnson & Johnson Vaginal Mesh Lawsuits

In the face of dozens of lawsuits filed by women who have suffered complications related to Ethicon’s vaginal sling devices, Johnson & Johnson announced it would withdraw many of its Gynecare products from the market. Gynecare Gynemesh PS is the only remaining product Ethicon will continue to market, but with restricted use limited to abdominal sacrolpopexy procedures for treating POP. For more information concerning the Johnson & Johnson Gynecare devices or the pending lawsuits, please contact our Johnson & Johnson vaginal mesh injury lawyers for a free case evaluation.

9 Comments

  1. jeff fisher
    Feb 13, 2013 @ 23:59:27

    My wife had a Johnson&Johnson Gynacare Prosima used in a procedure for incontinence several years ago that failed leaving pain and even worse urinary incontinence. It was repaired in a second operation this last summer but the original vaginal mesh could not be easily found or removed. She still has pain and extreme pain if intercourse is attempted.

    Reply

  2. Barbara
    Feb 04, 2014 @ 16:24:27

    I went in for a POP “Repair”. All my doctor said was “it doesn’t always work.” As a R.N. I am well aware this is said before any surgery to cover their butts.This was in 2008 AFTER the FDA warning was given. I was clueless that this Mesh/Sling was going to ROT inside me and ruin my life. I have pain, incontinence, and loss of intercourse w/ my husband. I can’t jump into my car and drive 300 miles to help with my grandchildren. In my opinion from what I have learned this was known to be tested on rabbits/Hamsters! This was total greed of large corporations and I hope all the companies that continued to sell this product get what they deserve. My condolences to you and your wife. I feel her PAIN/and suffering.

    Reply

  3. Rebecca
    May 08, 2014 @ 19:01:57

    I had surgery about a year ago because of a leaking problem and I have had pain since. My legs and hips hurt so bad that it has almost become unbearable. I cannot remember a night that I have not woken up with pain. My thighs hurt constantly and I am forever looking for pain cream or patchs that will ease the pain. Is this the way I am going to spend the rest of my life?

    Reply

  4. Linda
    Aug 19, 2014 @ 17:17:15

    I had one put in and a nerve grew right through it. I had to have shots from a pain management clinic to kill the nerve. From what my lawyers have told me all but Johnson & Johnson and Ethicon are negotiating. These people won’t even come to the table. Well I have a whole trash bag of underwear I would like to dump on their desk that I have gone through in the last 5 years I am back on more meds for incontinence and wearing a diaper at the age of 55.

    Reply

  5. Becky Thomas
    Aug 30, 2014 @ 18:25:03

    I had the same thing mine was falling in from the top and both sides the mesh was sticking out of my tissue and causing terrible pain especially during intercourse they removed. I guess all they could find but my vagina is so short and narrow that I. Can’t stand to have sec anymore we sleep in seperate bedrooms it’s like living with a roommate instead of a husband.. I believe they should pay dearly by putting fish line inside of me that was not meant for humans.

    Reply

  6. Sharon Roczynski
    Sep 10, 2014 @ 19:34:32

    SAME THING HAPPENED TO ME. I HAD THE TOT INSERTED IN 05. THE MESH IS NOW EMBEDDED IN MY PUBIC BONE AND TISSUES CAUSING EXTREME PAIN.. DOCTORS SAYS IT WOULD BE TRAUMATIC AND IMPOSSIBLE TO REMOVE. I AM ON PAIN MEDICATION DAILY. GOD ONLY KNOWS HOW MANY MORE ORGANS WILL BE AFFECTED BEFORE THE MESH FINALLY KILLS ME.

    Reply

  7. Gayle
    Sep 18, 2014 @ 18:51:39

    In 2007 I had a bladder mesh because my bladder was very incontinent. Only lasted 3 months now I have severe incontinent and I am in terrible pain. I was told my mesh can not be removed because my body has grown to it. I was not told that this would happen. Yes I have a Attorney I just wish that they would admit that this is a side effect from having the mesh surgical procedure. I hope things work out for you.

    Reply

  8. Kara
    Mar 27, 2015 @ 13:41:02

    I have had 5 surgeries for problems with bladder mesh. Going for my sixth surgery now. I filed a mesh lawsuit. Awarded $70,000 with 40% going to the attorneys plus their expenses. What the law firm does not tell you, your award deducts for many other fees never previously stated. A percentage of your award is set aside for others who may experience additional complication. A percentage is set aside for someone to research if you ever filed bankruptcy as you may have to pay back medical providers. Your insurance company can recoup their payments from your settlement award. And on an on. You will not get much when said and done. Oh, and did I mention Uncle Sam wants his share too?

    Reply

  9. Jean
    Aug 05, 2015 @ 08:12:22

    I never connected my ill health with my rectocele repair with Gynecare Prolift mesh in 2009. Now I’ve read about Foreign Body Response everything is falling into place. Before the op my only health prob was migraine and facial pain. Since the op I have so many symptoms, my GP has diagnosed Fibromyalgia, I diagnosed Hypothyroidism (I’m a nurse) I have high thyroid antibodies so it’s an auto immune disease.
    I can’t walk far my legs are just so weak and if I try to walk a longer distance I get pain in my hips/pelvis and numbness in my legs and feet.
    I’ve had to give up work due to tiredness and memory problems. It’s not looking good for the rest of my life! How can the manufacturers get away with this?

    Reply

Leave a Reply

*