Transvaginal Mesh Implants
News Alert, June 4, 2012!
Johnson & Johnson subsidiary Ethicon, manufacturer of several transvaginal mesh implants, announced that it is pulling four such products from the market, including:
- Gynecare TVT Secur system
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift Pelvic Floor Repair System
- Gynecare Prolift+M Pelvic Floor Repair System
This represents a major victory for the thousands of women who have filed or plan to file transvaginal mesh lawsuits.
Transvaginal Mesh Patch Failure
A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:
- Erosion of the vaginal tissue
- Urinary problems such as incontinence
- Pain during sexual intercourse (dyspareunia)
- Organ perforation (puncturing) from surgical tools during mesh implantation
Less frequent problems included
- Return of POP
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, contact the experienced medical device lawyers of Childers, Schlueter & Smith, LLC for a free consultation today by calling us toll-free at (800) 641-0098 or filling out the form on this page.
FDA Alerts and Research Find Transvaginal Patches Unsafe
2011 FDA Alert – Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also finds the risky surgical mesh treatment of POP to be no more effective than traditional treatment.
2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect including:
- 7 times the risk of bladder perforation
- Nearly twice the risk of urinary incontinence (loss of bladder control)
- 3.2 percent of women required follow-up surgery to correct problems
2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.
2010 Study Published – A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.
2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.
Over 2,000 Lawsuits Filed Already
More than 2,000 women across the United States have filed lawsuits at the federal and state levels against four manufacturers of transvaginal mesh patches:
- C.R. Bard
- Johnson & Johnson’s Ethicon
- American Medical Systems
- Boston Scientific
Complications have been reported for several other manufacturers of surgical mesh as well including:
- Mentor Corporation
What Should You Do?
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.
Contact the experienced medical device lawyers of Childers, Schlueter & Smith, LLC. for a free consultation. We will listen to your story and explain your legal rights to help you choose the best course for your claim.