The U.S. Food and Drug Administration (FDA) in the late 1990s and early 2000s approved transvaginal mesh implants as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Early on, these products were embraced by doctors as a simpler, easier way to create a long-term solution for women suffering from these embarrassing and often debilitating conditions. With nearly 500,000 of these surgeries performed each year, many medical device companies saw a potentially lucrative market to enter. Since the first transvaginal mesh product was approved by the FDA, nearly 40 companies, producing nearly 100 brands of vaginal mesh, have entered the market.
Paving the way for so many companies to produce multiple brands of mesh was an FDA decision to make transvaginal mesh a Class II product. This classification put a lighter burden on manufacturers to gain approval for their new products. Under Class II guidelines, and the FDA 510k program, manufacturers are only required to show that the device they are producing is substantially similar to a product that has already been approved and is on the market. This made it very easy for manufacturers to quickly and easily bring new vaginal mesh products to market.
Although there are a large number of companies manufacturing vaginal mesh, there are five companies considered dominant in the market: Johnson & Johnson, Bard Medical, American Medical Solutions, Boston Scientific and Coloplast. These companies produce multiple brands through multiple subsidiaries, making billions of dollars in profit every year.
Johnson & Johnson/Ethicon Transvaginal Mesh Products
Drugmaker Johnson & Johnson was eager to jump into the emerging mesh market and created a new mesh product line through its subsidiary, Ethicon Inc. Ethicon was charged with developing “easy-to-use” surgical mesh kits. These kits provided doctors with pre-cut mesh and the tools needed for the implant procedure.
Surgeons embraced the convenient new kits. They quickly became the preferred treatment for prolapse and incontinence. Ethicon’s Gynecare brands were believed to be superior to traditional surgery, but doctors had many more complications than they expected. The surgical mesh was difficult to implant, and complaints of severe post-surgery complications were common.
In June 2012, amid mounting legal pressure and growing concern from the FDA, Ethicon announced that it would no longer manufacture and distribute vaginal mesh products. However, both Ethicon and J&J have refused to call the decision a recall. Due to the injuries caused by these products, thousands of lawsuits have been filed against Ethicon and J&J.
Gynecare Prolift Kit
J&J started selling the Gynecare Prolift Kit for prolapse treatment in 2005 without marketing approval from the FDA. The FDA scolded J&J for breaking the rules, but approved the Prolift anyway in 2008.
Gynecare TVT Secur
The Gynecare TVT Secure was the first mini bladder sling used in the United States. Instead of using needles, the U-shaped TVT Secur has built-in blades for attaching the mesh. However, the TVT Secur is more likely to loosen after surgery.
Gynecare Prosima Pelvic Floor Repair System
J&J tried to perfect the mini bladder sling with the Gynecare Prosima Kit. It uses slits cut with scissors to implant the mesh, instead of needles. A tiny balloon is then placed on top of the anchored mesh and inflated to support organs after surgery. The balloon is removed 24 hours after the operation. Because of the way it is attached, this mesh is useful only if incontinence is caused by organs dropping to the back of the vagina; it is likely to fail if organs prolapse toward the front.
Gynecare Prolift + M Kit
In another effort to avoid patient complaints of vaginal scarring and perforation J&J created the Gynecare Prolift +M to treat prolapse. It was the first surgical mesh in the United States to use plastic fibers that could be partially absorbed by the body. This mesh isn’t as dense as the Prolift, and it has larger holes that are supposed to help patients heal after surgery. The mesh also resists folding and wrinkling. Despite J&J’s efforts, the Prolift + M eroded and shrank, just like many of its other mesh brands.
Bard Medical Transvaginal Mesh Products
Like Johnson & Johnson, Bard Medical’s brands were approved under the 510(k) process. Bard even outsourced the clinical testing for its Alyte Y-Mesh device, relying on data from a 2010 European survey of 17 surgeons to get the brand approved by the FDA. Bard makes transvaginal mesh kits for both prolapse and incontinence.
Hundreds of patients who received Bard transvaginal mesh have already filed lawsuits against the company for injuries related to the products. These customers suffered from erosion, organ perforation, nerve damage, migrated mesh and infection caused by Bard’s brands.
|Bard Transvaginal Mesh Products|
|Prolapse Repair||Bladder Sling|
|Alyte Y-Mesh Graft||Ajust Adjustable Single-Incision Sling|
|Avaulta Solo Anterior and Posterior||Align Urethral Support System|
|Avaulta Plus Anterior and Posterior||Pelvilace BioUretral Support System|
|Pelvicol Acellular Collagen Matrix (Pelvicol Pelvisoft Tissue)||Pelvilace Trans-Obturator BioUrethral Support System|
|Pelvisoft BioMesh||Uretex Self-Anchoring Urethral Support System|
|Pelvitex||Uretex Trans-Obturator Urethral Support System|
Endo Pharmaceuticals/ American Medical Systems’ Transvaginal Mesh Products
American Medical Systems made mesh for both stress urinary incontinence and pelvic organ prolapse throughout the 2000s. In 2011, the company was purchased by Endo Pharmaceuticals. Some patients are suing both Endo and American Medical Systems to recover medical costs from injuries sustained from their transvaginal mesh products. Removal and revision surgeries for American Medical Systems transvaginal mesh brands happen frequently. It is unclear whether the courts will consider Endo Pharmaceutical liable for American Medical Systems’ faulty products. Endo argues it cannot be sued for the actions of its subsidiary.
|American Medical Systems Transvaginal Mesh Products|
|Prolapse Repair||Bladder Sling|
|Apogee||MiniArc Precise Sling|
|Perigee||MiniArc Single-Incision Sling|
|Elevate Anterior and Posterior Repair||Monarc Subfascial Hammock|
|InteXen||In-Fast Ultra Transvaginal Sling|
|IntePro||BioArc SP Sling|
|The Straight-In||BioArc Trans Obturator Subfascial Hammock|
|Elevate with InteXen LP||InVance Male Sling|
Boston Scientific Transvaginal Mesh Products
Boston Scientific is facing at least 300 lawsuits over its mesh and incontinence products. Like the other manufacturers, Boston Scientific’s brands injured many patients when the faulty mesh eroded and punctured organs. The company has stated it still believes transvaginal mesh is an important treatment for incontinence and pelvic organ prolapse. Boston Scientific’s revenue was $7.6 billion in 2011, and transvaginal mesh sales made up less than 5 percent of the company’s revenue.
|Boston Scientific Transvaginal Mesh Products|
|Prolapse Repair||Bladder Sling|
|Pinnacle Pelvic Floor Repair Kit||Advantage Transvaginal Mid-Urethral Sling System|
|Uphold Vaginal Support System||Prefyx PPS Sling|
|Polyform Synthetic Mesh||Obtryx Sling|
|Lynx Suprapubic Mid-Urethral Sling|
|Obtryx Transobturator Mid-Urethral Sling|
Coloplast Transvaginal Mesh Products
Coloplast markets mesh products for repair of prolapse and incontinence. The company is facing dozens of lawsuits, which have been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia. The patients say Coloplast’s mesh products caused serious injury.
The FDA ordered dozens of manufacturers to conduct studies on their mesh products, including Johnson & Johnson/Ethicon, Bard Medical, Endo Pharmaceuticals/ American Medical Systems, Boston Scientific and Coloplast. While each company makes its own version of transvaginal mesh many of the products are similar in both their design and the material used to construct the mesh. Most transvaginal mesh brands are prone to erosion and organ perforation. Because the complaints the FDA received on mesh complications are not tied to any specific transvaginal mesh manufacturer, all companies that produce transvaginal mesh brands are potentially liable for compensating patients for injuries caused by their products.
|Other Transvaginal Mesh Manufacturers and Products|
|Coloplast||Exair, Supris Suprapublic Sling, T-Sling, Aris Transobturator Sling, Restorelle, Minitape, Omnisure, Novasilk sling|
|Pegasus Biologics||Orthadapt, Orthadapt, Bioimplant|
|Prosurg||Easy Lift, Minisling, Zippere|
|RTI Biologics||Tutopatch Tutomesh|
|Tyco Healthcare||IVS Tunneller|
|Covidian||Duo, IVS Tunneler, Parietene Mesh, Surgipro Mesh|
|Sofradim||Pelvetex, Uretex, Uretex Sling, UretexTO, Uretex TO Avaulta BioSynthetic System|
|Serica Technologies Inc.||SeriScaffold|
|Surgicraft||Surgicraft Surgical Mesh|