Various vaginal mesh brands marketed by American Medical Systems, Johnson & Johnson’s Ethicon division, C.R. Bard and Boston Scientific have been named in vaginal mesh lawsuits alleging the devices caused women to suffer horrific and painful complications following the vaginal repair of pelvic organ prolapse and stress urinary incontinence. Unfortunately, the vaginal mesh products at the center of these lawsuits were approved by the U.S. Food & Drug Administration (FDA) without any human testing, thanks to a fast-track approval process known as 510(k).
Vaginal Mesh and 510(K) Approvals
Vaginal mesh products used in the treatment of pelvic organ proplapse and stress urinary incontinence are currently categorized as Class II, or moderate risk, medical devices by the FDA. Such devices are not required to undergo human testing if it can be shown that they are “substantially equivalent” to a product already on the market. Boston Scientific’s ProteGen Sling was brought to market in 1996, and was the first vaginal mesh device approved by the FDA. In 1998, Johnson & Johnson would use the ProteGen Sling as the predicate to garner a 510(K) clearance for its Gynecare TVT product. The Gynecare TVT would later become the predicate in 510(k) applications for other vaginal mesh devices. Those devices, in turn, would be cited in applications for even more vaginal mesh products.
The ProteGen sling was recalled just two years after it came on the market, after many of the women who had received it complained of serious problems including pain during intercourse, damage to vaginal tissue and infection. Yet according to a Bloomberg.com report published in October 2011, the FDA did not look into any of the other 510(k) approvals that could trace their origins back to ProteGen. In a report released in January 2012, even the FDA acknowledged that the use of recalled predicates in 510(K) approvals could “put patients at risk.”
Johnson & Johnson/Ethicon Vaginal Mesh Brands
Johnson & Johnson’s Ethicon unit brought the Gynecare TVT product to market just two years after the ProteGen sling was launched. Other vaginal mesh brands marketed by Johnson & Johnson and Ethicon include:
- Gynecare Prolift
- Gynecare Prosima
- Gynecare Prolift + M
- Gynecare TVT Secur
In July 2012, Johnson & Johnson announced it would no longer sell Gynecare Prolift, Gynecare Prolift+ M, Gynecare TVT Secur and Gynecare Prosima surgical meshes. However, the company has maintained that safety concerns did not play a role in its decision.
American Medical Systems Vaginal Mesh Brands
American Medical Systems, now a unit of Endo Pharmaceuticals, has sold vaginal mesh for pelvic organ prolapse and stress urinary incontinence. American Medical Systems brands used for pelvic organ prolapse include:
- Elevate Anterior and Posterior Repair
- The Straight-In
- Elevate with InteXen LP
Vaginal mesh brands sold by American Medical Systems to treat stress urinary incontinence include:
- MiniArc Precise Sling
- MiniArc Single-Incision Sling
- Monarc Subfascial Hammock
- In-Fast Ultra Transvaginal Sling
- BioArc SP Sling
- BioArc Trans Obturator Subfascial Hammock
- SPARC Sling
- Monarc Sling
Boston Scientific Vaginal Mesh Brands
- Monarc Sling
- Uphold Vaginal Support System
- Polyform Synthetic Mesh
Boston Scientific also markets vaginal mesh products for stress urinary incontinence, including:
- Advantage Transvaginal Mid-Urethral Sling System
- Prefyx PPS Sling
- Obtryx Sling
- Lynx Sling
- Advantage Mesh
- Advantage Fit
- Lynx Suprapubic Mid-Urethral Sling
- Obtryx Transobtubator Mid-Urethral Sling
C.R. Bard Vaginal Mesh Brands
C.R. Bard makes vaginal mesh kits for both prolapse and incontinence. Those used for pelvic organ prolapse repair include:
- Alyte Y-Mesh Graft
- Avaulta Solo Anterior and Posterior
- Avaulta Plus Anterior and Posterior
- Pelvicol Acellular Collagen Matrix (Pelvicol Pelvisoft Tissue)
- Pelvisoft BioMesh
- Faslata Allograft
C.R. Bard brands used in stress urinary incontinence repair include:
- Ajust Adjustable Single-Incision Sling
- Align Urethral Support System
- Pelvilace BioUretral Support System
- Pelvilace Trans-Obturator BioUrethral Support System
- Uretex Self-Anchoring Urethral Support System
- Uretex Trans-Obturator Urethral Support System
Lawsuits Against Vaginal Mesh Manufacturers
American Medical Systems, Johnson & Johnson’s Ethicon division, C.R. Bard and Boston Scientific are all considered to be among the top vaginal mesh manufacturers in the U.S. Together they are facing thousands of lawsuits filed on behalf of women who’ve suffered crippling injuries, allegedly due to the devices’ defects. Currently, all of these manufacturers are named in multidistrict litigations underway in U.S. District Court, Southern District of West Virginia: In re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325); In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326); In re: C. R. Bard, Inc. Pelvic System Products Liability Litigation (MDL 2187); and In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327).
Injured by One of These Vaginal Mesh Brands? Contact Us Today.
If you or a loved one were injured by any of the vaginal mesh brands listed above, you may be entitled to significant compensation for your medical bills, lost wages, pain and suffering, and other damages. Please seek the advice of a doctor as soon as possible, and keep track of your medical appointments and time off work due to your injury. It would also be a good idea to ask your doctor for copies of your medical records, as they will be important evidence in your vaginal mesh lawsuit.
The attorneys of Bernstein Liebhard LLP offer free legal evaluations to victims of vaginal mesh injuries. To learn more, please give us a call today at 1-(888)-217-3033.