A growing number of women have filed vaginal mesh lawsuits against a number of medical device manufacturers, including American Medical Systems, Johnson & Johnson, C.R. Bard, and Boston Scientific. If you or a loved one experienced vaginal mesh complications, you may be able to file a transvaginal mesh lawsuit seeking compensation for medical expenses, pain and suffering, lost wages, and more. The vaginal mesh lawyers at Bernstein Liebhard LLP are directly involved in the litigation involving transvaginal mesh products, and are available to answer all of your questions regarding this complex litigation.
Vaginal Mesh Complications
Transvaginal mesh implants are attached or implanted to the vaginal wall and are meant to treat pelvic organ prolapse and stress urinary incontinence. Because transvaginal mesh was approved through a fast-tracked federal process known as 501(k), the products did not receive clinical safety testing for that use. In fact, a number of transvaginal device manufacturers received U.S. Food and Drug Administration (FDA) clearance for their products based on the use of mesh material used in surgeries for other body parts, such as hernia repair.
As early as 1999, injury reports related to the use of transvaginal mesh were being received. That year, Boston Scientific issued a recall for some 20,000 Protegen transvaginal mesh implants. Despite the Protegen recall, the FDA continued to approve 510(k) vaginal mesh applications that were based on substantial similarities to the recalled Boston Scientific devices.
Injuries from transvaginal mesh devices may include:
- Erosion through the vaginal epithelium
- Painful sexual intercourse
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Chronic pain
- Vaginal scarring
Vaginal Mesh Lawsuits
Thousands of women have filed transvaginal mesh lawsuits after allegedly suffering serious and severe injuries following surgery to repair pelvic organ prolapse and stress urinary incontinence. Many of these claims have been consolidated in four multidistrict litigations currently underway in U.S. District Court, Southern District of West Virginia: In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2325”); In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2326); In re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2187”); and In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (“ MDL No. 2327”). Bernstein Liebhard LLP partner, Jeffrey S. Grand, is serving on the Plaintiffs’ Steering Committees in all of these proceedings.
Two consolidated proceedings involving vaginal mesh claims are also underway in New Jersey Superior Court, Atlantic County, involving products manufactured by Ethicon Inc. and C.R. Bard. (In re: Pelvic Mesh Litigation/Bard, No. L-6339-10, and In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10). Bernstein Liebhard LLP partner, Jeffrey Grand is serving as Co-Liaison Counsel in both of these litigations.
In early March 2013, first U.S. trial involving an Ethicon mesh product concluded in the New Jersey litigation, with the jury awarding more than $11 million to the Plaintiff, including $7.76 million in punitive damages. Mr. Grand was also part of the trial team in that case.
Vaginal Mesh Recalls
In 2012, Johnson’s & Johnson’s Ethicon unit decided to stop selling four Gynecare pelvic mesh products; however, the company maintained this action was done for commercial reasons and did not constitute a vaginal mesh recall. At the same time, Ethicon notified the FDA that it would change the indication for its Gynemesh product, advising surgeons that Gynemesh should no longer be transvaginally placed and should only be implanted via abdominal incisions.
Other than the 1999 vaginal mesh recall for the Boston Scientific product, no other recalls have officially been announced. However, the FDA has ordered the manufacturers of transvaginal mesh used in pelvic organ prolapse repair to conduct post-market safety studies of their products to help it better understand their safety profiles. The agency is also considering reclassifying devices used in prolapse repair as high risk, which would make them ineligible for 510(K) approvals.
Contact a Vaginal Mesh Lawyer for Your Free Consultation
If you experienced vaginal mesh complications and are considering filing a vaginal mesh lawsuit, Bernstein Liebhard can explain your legal rights and options. A vaginal mesh lawyer who understands the sensitive nature associated with these cases will evaluate your case free of charge. To get started, please call 1-888-217-3033 or fill out the Case Evaluation Form on this page, and one of our attorneys will get back to you promptly.