Transvaginal mesh lawsuits are currently being filed, alleging serious side effects. If you have suffered side effects after being treated with a transvaginal mesh patch before 2012, you may be entitled to compensation for medical bills, lost income and pain and suffering, among other losses. We are working with experienced transvaginal mesh lawyers across the country, who do not charge a fee unless you get a settlement or award. Contact us toll free at any time, or visit us online for a free, no obligation consultation.
FDA Warning on Transvaginal Mesh – Dr. Peggy Norton
University of Utah Health Care | July 14, 2011
What Is Transvaginal Mesh?
Transvaginal mesh products are patches of material that are placed in the vaginal wall in order to give support to internal organs, such as the vagina, bladder, bowel, rectum, and uterus. The patches are made from either synthetic plastics or natural products. Many transvaginal mesh products contain collagen. These products are inserted during a relatively simple surgical procedure and have become a popular option for doctors across the country after being marketed as safe by manufactures such as Boston Scientific.
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What Conditions do Transvaginal Mesh Products Treat?
Transvaginal mesh products were designed to treat two very common issues: Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). POP is caused when the muscles of the vaginal wall become weak, and the internal organs press on the wall causing discomfort. SUI is a condition caused by a loss of support of the urethra, which can lead to bladder leaks. The issues can often affect women who are pregnant, recently were pregnant, have had a hysterectomy, or who have gone through menopause. The FDA estimates that as many as 300,000 women per year receive surgical treatment for POP, and about 25% of those surgeries used transvaginal mesh. In turn, about 250,000 women get surgery to address SUI, and around 80% of those surgeries used transvaginal mesh.
Why Are There Transvaginal Mesh Lawsuits?
Plaintiffs allege that the makers of transvaginal mesh products failed to manufacture a safe product. Lawsuits filed specifically claim that the makers of the mesh products knew or should have known that the products were not safe and likely to cause injury. Even though the potential for injury was clear, the medical companies continued to market the products as a safe alternative to other surgical procedures that could address the problem. Transvaginal mesh lawsuits have been filed across the country. Due to the high number of these claims, they have been consolidated into multidistrict litigation (MDL) cases that will all be heard in front of the same judge. This process helps save time and money by allowing plaintiffs to establish certain factual claims at the same time.
Have Transvaginal Mesh Lawsuits Been Successful?
A jury in Delaware awarded a 51-year-old woman $100 million dollars in her transvaginal mesh case. This is the largest settlement awarded thus far. The Worcester Telegram reported:
Boston Scientific Corp. must pay $100 million to a Delaware woman who blamed the company’s vaginal-mesh inserts for leaving her in constant pain and unable to have sex, in the first verdict after the company agreed to begin settling cases over the devices, and the biggest yet.”
Boston Scientific was hit with another large jury verdict in in 2014 when a jury ordered the medical device manufacturer to pay $6.7 million to a woman who experienced severe complications after having a Boston Scientific transvaginal mesh implanted in her in 2008. The experienced transvaginal mesh lawyers that we work with can answer any questions you have regarding your potential case.
Who Manufactures Transvaginal Mesh Patches?
The following companies manufacture transvaginal mesh products and are currently facing lawsuits:
- Coloplast Corp.
- Cook Medical, Inc.
- Neomedic International
- Boston Scientific Corporation
- American Medical Systems, Inc.
- Johnson & Johnson
- Ethicon, Inc.
- C. R. Bard, Inc.
- Sofradim Production
- Tissue Science Laboratories
What Are Common Transvaginal Mesh Side Effects?
- Recurrence of POP or SUI
- Erosion of vaginal tissue or the transvaginal mesh itself
- Bladder perforation
- Urinary problems
- Vaginal scarring and damage
- Severe vaginal pain and discomfort
- Painful sexual intercourse
- Inability to have sexual intercourse
What Has The FDA Done?
In July of 2011, the FDA issued a Safety Communication, which stated that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” The communication was based upon scientific literature that numerous reports of vaginal, tightening, and pain associated with transvaginal mesh products. In early 2012, the FDA announced that it would be treating the situation more seriously by announcing a 522 Postmarket Surveillance Study. The 522 would require manufacturers to conduct thorough research of their own and submit it to the FDA for review. Several manufacturers decided to discontinue their transvaginal mesh products rather than conduct postmarket surveillance.
Timeline of Events and Lawsuits:
- In 1996 – FDA approved Boston Scientific’s first version of the transvaginal mesh patch.
- Between 1996 and 2008 – Many other manufacturers used Boston Scientific’s product as a model and introduced their own transvaginal mesh products to the market, using the FDA 510(k) “fast track” approval.
- October, 2008 – The FDA declares that over 1,000 complaints had been made over transvaginal mesh products.
- July, 2011 – The FDA states that serious side effects of transvaginal mesh products were common and life altering.
- January, 2012 – The FDA warned manufacturers that it was going to be conducting strict product testing on transvaginal mesh patches, which led to many companies discontinuing production of the patches.
- July, 2013 – American Medical Systems settled an undisclosed number of cases for $54.4 million.
- March, 2014 – Coloplast settled around 400 cases by paying $16 million.
- May, 2014 – American Medical Systems settled roughly 20,000 cases by paying $830 million total.
- April, 2015 – Over 72,500 individual transvaginal mesh lawsuits are still pending against 7 different manufacturers.
- October 2017 – Boston Scientific ordered to pay 6.7 million to a women injured by the Pinnacle Pelvic Floor Repair Kit.
Contact Us Today!
If you were treated with a transvaginal mesh before 2012, you may be entitled to compensation for medical bills, lost income, and pain and suffering, among other losses. Our law firm works with some of the more experienced transvaginal mesh lawyers across the country, who are investigating these claims. They may be able to file a lawsuit on your behalf. There are no legal fees unless you receive a settlement or award for your injuries. Contact us toll free at 1-800-992-6878 for a free, no obligation case evaluation, or fill out a contact form online.