Our lawyers are investigating vaginal mesh and bladder sling lawsuits involving Gynecare (Ethicon) Prolift, Bard Avaulta, AMS and other manufacturers of vaginal mesh systems. You can get a 2013 update on these lawsuits here.Overview of Mesh/POP Lawsuits
You don't hear a lot about vaginal prolapse. It is incredibly common. Approximately 30-50% of women have some sort of vaginal prolapse during their lives. Simply put, there is a network of muscles, ligaments, and skin in and around the vagina.
Many women have a claim but just can't decide if they want to bring one. We understand. You can get our thoughts on your choice here.
This network acts as a complex support structure that holds pelvic organs, tissues, and structures in place. If the network is weakened, elements of the support system may eventually weaken or break. This is called vaginal prolapse.
One solution when the problem reaches a critical mass with patients: synthetic mesh devices (also referred to as tapes or slings) that are generally made of polypropylene. In the past few years the FDA has received nearly 4,000 reports of complications associated with mesh devices used in pelvic organ prolapse repair. Complications include erosion through the vaginal walls, pain, painful sexual intercourse or the inability to have intercourse. Complications of surgical mesh implantation can be debilitating and have not been linked to a single brand of mesh. Though sexual problems often result from pelvic organ prolapse, implantation of vaginal mesh devices have also been reported to result in sexual dysfunction in women especially with respect to increased reports of dyspareunia (painful intercourse).
Over 75% of women receiving surgery for pelvic organ prolapse are postmenopausal. Menopause brings about many changes including estrogen deficiency which results in changes to vaginal pH, overactive bladder, dryness and painful sexual intercourse. Though pelvic organ prolapse surgery can correct the process of prolapse, it can negatively impact sexual function.Results of the Studies
A study was recently published which was conducted in 69 women who underwent transvaginal mesh surgeries for pelvic organ prolapse. All women studied were sexually active and menopausal. Subjects completed an FSFI questionnaire (a questionnaire designed and validated to assess female sexual function). The questionnaire is designed to evaluate six domains: sexual desire; sexual arousal; lubrication; orgasm; satisfaction; dyspareunia (pain). The questionnaire was completed prior to and 6 months post-surgery. Post-operative scores were compared to pre-operative questionnaire scores. Though there were no significant changes in sexual desire, sexual arousal, orgasm or satisfaction, scores for lubrication and dyspareunia worsened. Further, 66.7% of patients studied had lower FSFI scores post-operatively.
Another study conducted in 36 premenopausal and 32 postmenopausal women reported that one third of premenopausal women studied had worsening sexuality domain after an operation with transvaginal mesh and a higher rate of dyspareunia (painful intercourse) compared to postmenopausal women.
Results of these studies suggest that regardless of menopausal status, adverse effects with respect to sexual function may result from transvaginal mesh surgeries. The wide dissection which occurs during transvaginal mesh implant operations may lead to nerve damage resulting in vaginal wall congestion and lubrication alterations and ultimately lead to impairment of sexual function. Use of synthetic materials in mesh implant surgeries may result in dyspareunia, dryness and other problems especially in cases where the mesh erodes the vaginal wall.
Although sexual dysfunction is highly prevalent in women, and is estimated to surpass male sexual dysfunction, it receives less attention than for male counterparts. Sexual dysfunction in women can be debilitating and often results in a negative impact on social and emotional well-being and can result in relationship problems with partners, leading to an impaired quality of life for these women.
The purpose of pelvic mesh products is to provide support for prolapsed pelvic organs (POP) and urinary incontinence (SUI) that comes with weakened muscles due to childbirth, age, or other causes. These lawsuits claim the vaginal mesh manufacturers failed to make a safe product. These bladder slings did not go through full clinical trials and instead snuck on the market by the Section 510(k) exception that these vaginal mesh implants were substantially equivalent to other similar products already on the market.Being a Plaintiff in These Lawsuits: Your Choice
Patients in these cases are in a tough spot. They had a problem that caused them embarrassment and got to the point where they reached out for a solution. Now the solution is worse than the original problem itself. The reason why this happened, plaintiffs' lawyers and victims argue: no one tested these products to make sure they were safe.
On top of all of this, women are now uncomfortable bringing a claim against these vaginal mesh manufacturers because they want to protect their privacy. But, as the settlements we have already seen have shown, these may be very valuable cases. Some women are just never going to bring a claim. We get that. But just keep in mind: these cases are sitting in another jurisdiction. The majority of women who have claims never meet their lawyers, much less find themselves in court. Could that happen? Of course it could. But it is unlikely in a mass tort cases like these vagainl mesh lawsuits. Ultimately, you need to make your own choice as to what is best for them. If you just want more information, you can get that by making a confidential on-line inquiry or call 800-553-8082.Types of Vaginal Mesh Lawsuits
We are looking at the following types of vaginal mesh cases:
- Bard Avaulta Support System
- AMS Elevate Prolapse Repair System
- AMS Apogee Vault Suspension System
- AMS Perigee System
- AMS Monarc Sling System
- AMS Sparc Sling System
- Boston Scientific Pinnacle Pelvic Floor Repair Kit
- Boston Scientific Uphold Vaginal Support System
- Ethicon Gynecare Gynemesh
- Ethicon Gynecare Prolene Soft Mesh
- Ethicon Gynecare Prolift Pelvic Floor Repair System
- Ethicon Gynecare TVT Transvaginal Sling
- UGYTEX Dual Knit Mesh
- Coviden IVS Tunneler Sling
If you have experienced transvaginal mesh side effects and feel you may be entitled to money damages for your injuries, fill out our free case review form or call us at 800-553-8082. Again, this may be just getting information; it is not a decision to bring a claim or file a lawsuit.