Over 100,000 vaginal mesh lawsuits have been filed against several manufacturers. The FDA has warned that serious complications are “not rare,” and may include vaginal erosion, scarring, nerve damage, disfigurement of the vagina, pelvic pain, and more. Many women have had multiple corrective surgeries and continue to suffer from complications.
Do I Have a Vaginal Mesh Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by vaginal mesh, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
What is Vaginal Mesh?
Vaginal mesh (or pelvic mesh, transvaginal mesh, pelvic sling or tape) is a medical device that is implanted into a woman’s pelvis through incisions in her vagina. When placed correctly, the hammock-like device sits in the center of the pelvis and supports weakened, sagging pelvic muscles that normally support abdominal organs. This is used to treat two conditions:
- Pelvic Organ Prolapse (POP) – When abdominal organs protrude into the vagina or rectum
- Stress Urinary Incontinence (SUI) – When weakened pelvic muscles allow the urethra to open inadvertently, usually when a woman coughs, sneezes, laughs, or runs.
Vaginal Mesh and the FDA’s 510(k) Approval
Many types of vaginal mesh that are currently on the market were approved under the FDA’s 510(k) fast-track approval system. New devices that are “substantially similar” to an approved device do not have to conduct safety studies in their approval application. Although most people assume that a medical device implanted in their body has been thoroughly tested and is safe, this is not always the case.
According to Elaine Houghton, attorney for a woman who filed a vaginal mesh lawsuit, “They tested this on 12 rats, 16 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women.”
The FDA also continued to approve new vaginal mesh products that were “similar” to Boston Scientific’s ProteGen vaginal mesh, which was recalled due to safety concerns.
Vaginal mesh is now re-classified as a “high-risk” medical device. This means that manufacturers must conduct safety studies to keep vaginal mesh products on the market. The FDA also ordered 31 manufacturers to conduct three-year safety studies. Instead of conducting the studies, Johnson & Johnson voluntarily recalled all four of its vaginal mesh products.
Vaginal Mesh and FDA Safety Warnings
The FDA has received thousands of reports of serious complications caused by vaginal mesh. Because these reports are voluntarily submitted, they likely under-represent the total number of women who have been injured by vaginal mesh. The FDA has issues two safety warnings:
- October 20, 2008 — FDA published a Public Health Notification to warn that they had received more than 1,000 reports of vaginal mesh side effects.
- July 13, 2011 — FDA published a Safety Communication Update to warn that they had continued to receive thousands of reports of serious side effects, and these complications were “not rare.”
The FDA has never forced manufacturers to recall vaginal mesh. Some manufacturers have voluntarily stopped selling the devices, claiming the decision was prompted by declining sales and not safety concerns.
Vaginal Mesh MDLs
More than 100,000 vaginal mesh lawsuits are now pending in a federal Multi-District Litigation (MDL). Most of the lawsuits are centralized in West Virginia before Judge Joseph R. Goodwin:
- C.R. Bard, MDL No. 2187
- American Medical Systems, MDL No. 2325
- Boston Scientific, MDL No. 2326
- Johnson & Johnson, Ethicon, MDL No. 2327
- Coloplast Corp, MDL No. 2387
- Cook Medical, MDL No. 2440
For a list of types of vaginal mesh and manufacturers, click here.
Vaginal Mesh Side Effects
The FDA has warned that serious vaginal mesh side effects are “not rare.” The most common side effect is vaginal mesh erosion. Over time, the mesh can erode tissues and perforate the colon, vagina, bladder, or blood vessels. This often requires corrective surgery, but even surgery may not be able to correct permanent side effects, such as scarring, nerve damage, and pain.
Side effects of vaginal mesh include:
- Ilioinguinal nerve block
- Pudendal neuralgia
- Vaginal Mesh Erosion
- Chronic pelvic pain
- Pain during sexual intercourse
- Perforation of bladder, blood vessels, intestines, or vagina
- Shrinkage of mesh, which can cause shortening of the vagina
- Disfigurement of the vagina
- Severe scarring due to multiple surgeries
- Infection, which may be life-threatening or disfiguring
- Bleeding, vaginal discharge
- Recurrent incontinence or organ prolapse
- Inability to have sexual intercourse
- Emotional damage
- Decreased quality of life
- And more
Do I have a Vaginal Mesh Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas vaginal mesh lawsuit review.