Transvaginal mesh lawsuits are currently being filed, alleging serious side effects. You may be entitled to compensation for medical bills, lost income and pain and suffering, among other losses. We are working with some of the more experienced transvaginal mesh lawyers in the country, who do not charge a legal fee unless you get a settlement or award. Contact us 24/7, toll-free, or fill out a contact form online.
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. It was first designed by Boston Scientific, and introduced to the market in 1996. Later, in 1999, Boston Scientific issued a voluntary recall of many of their transvaginal mesh products. Nevertheless, it became an enormously popular medical device throughout the United States.
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.”
The very experienced Transvaginal Mesh lawyers that we work with can answer any questions you have regarding your potential case.
Have You Suffered From Any of The Side Effects
Associated With Transvaginal Mesh?
Call Us Now For a Free Case Evaluation!
Other Successful Transvaginal Mesh Cases:
- $73.5 million to a Texas woman in 2014. She was treated with a Boston Scientific device for minor SUI, and wound up requiring over 40 additional surgeries to fix injuries caused by the transvaginal mesh.
- $26.7 million to four Florida women in 2014.
- $18.5 million to four West Virginia women in 2014.
- $11.1 million to a New Jersey woman in 2013.
- $5.5 million to a California woman and her husband in 2012.
- $3.27 million to a West Virginia woman in 2014.
- $2 million to a West Virginia woman in 2013.
Other Successful Transvaginal Mesh Cases:
Transvaginal mesh products were designed to treat two very common issues: Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The issues affect women who are pregnant, recently were pregnant, have had a hysterectomy, or who have gone through menopause.
POP is a very common condition which mainly affects pregnant women, or women who have recently given birth. POP is caused when the muscles of the vaginal wall become weak, and the internal organs press on the wall. The organs protrude into the vagina and cause severe discomfort. The FDA says that as many as 300,000 women per year receive surgical treatment for POP, and about 25% of those surgeries used transvaginal mesh. The product is implanted through the wall of the vagina, which helps to stabilize the vaginal wall and which keeps internal organs from pressing into the vagina.
SUI is a condition where small amounts of urine leak during periods of physical exertion. SUI is caused by a loss of support of the urethra. When there is an increase in abdominal pressure, such as during a sneeze, coughing fit, or other type of physical exertion, a small amount of urine leaks from the urethra. The FDA estimates that over 250,000 women get surgery to address SUI, and around 80% of those surgeries used transvaginal mesh. When used for this condition, the product provides support to the urethra.
Why Are There Transvaginal Mesh Lawsuits?
Transvaginal mesh lawsuits allege several related, but different, things. First, some lawsuits allege that there was not enough warning about the seriousness of the side effects. Second, some lawsuits allege that the individual device used in them was defective, but not that all devices used in everyone were defective. Third, some lawsuits allege that all transvaginal mesh devices were too dangerous to be introduced to the market.
Most transvaginal mesh lawsuits say that the manufacturers of the products misled them into using the product. They state that the side effects were understated, and that if they knew of the high likelihood of serious side effects, they never would have been implanted with the devices. As a manufacturer, companies have a legal duty to provide safe products for their customers, and a duty to warn of side effects which might result. The lawsuits allege that the companies did not conduct enough testing before introducing their unsafe devices to the market and that they did not give enough warning about potentially serious side effects.
What Are Common Transvaginal Mesh Side Effects?
- Recurrence of POP or SUI
- Erosion of vaginal tissue or the transvaginal mesh itself
- Perforation of the bowel, bladder, or blood vessels
- Urinary problems
- Vaginal scarring
- Severe pain and discomfort in the vagina
- Painful sexual intercourse
- Inability to have sexual intercourse
Are There Medical Studies About the Side Effects of Transvaginal Mesh?
- August, 2010 – Obstetrics & Gynecology reported that they had to end a transvaginal mesh clinical study early due to too many complications which were suffered by participants. After just 3 months, 15% of the women had experienced severe erosion of the device, which could potentially cause serious health problems.
- February, 2011 – The Journal of Obstetrics and Gynecology Canada recommended that transvaginal mesh products should be considered experimental after their study showed that adverse events were much more likely to occur than was previously believed.
- November, 2011 – The Journal of Minimally Invasive Gynecology released a study showing that transvaginal mesh treatments are not as favorable as they were original reported, and that complications were significant.
What Has The FDA Done?
For years after the voluntary Boston Scientific recall the government waited to act on transvaginal mesh products. They collected complaints and data related to the products, but issued no warnings or recalls. In the summer of 2011, the FDA issued a warning that transvaginal mesh devices could be dangerous, and advised women to seek alternate treatment if they could. They finally issued a recall for certain Boston Scientific transvaginal mesh products in September of 2011.
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.
Who Manufactures Transvaginal Mesh Patches?
There are 7 major companies that manufacture transvaginal mesh products and that are currently facing lawsuits:
- C.R. Bard, Inc.
- American Medical Systems, Inc.
- Boston Scientific Corp.
- Ethicon, Inc. (a daughter company of Johnson & Johnson)
- Coloplast Corp.
- Cook Medical, Inc.
- Neomedic International
Most manufacturers stopped making their transvaginal mesh products after the recall issued by the FDA in September of 2011. In June of 2012, Johnson & Johnson’s Ethicon, Inc. announced that it would no longer be selling its transvaginal mesh products, but denied that the FDA had anything to do with their withdrawal from the market. They claimed that it was no longer profitable to continue making transvaginal mesh devices.
Timeline Of Events and Lawsuits:
- In 1996 – The FDA approved Boston Scientific’s 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.
- In 1999 – Boston Scientific voluntarily recalls its transvaginal mesh products, but the other manufacturers did not.
- 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 not rare, but 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.
Contact Us Today:
If you were treated with transvaginal mesh, 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 in the country, who can file a lawsuit on your behalf. There are no legal fees until you receive a settlement or award for your injuries. Contact us, toll free, 24/7 for a free (no obligation) case evaluation, or fill out a contact form.