Transvaginal Mesh

Debilitating pain, multiple surgeries and broken relationships have all been attributed to complications with transvaginal mesh – the former go-to treatment for conditions like stress urinary incontinence (SUI) and pelvic organ prolapse (POP) that often plague middle-aged and older women. Bladder slings, patches and vaginal mesh implants promised to strengthen weakened tissues and shore up pelvic organs in women who suffered rectocele or SUI, but post-marketing reports and products liability litigation tell a much bleaker story about these medical devices.

First launched in 1996, surgical mesh products are made by various manufacturers that use a range of synthetic or biological materials in their devices, which are designed for permanent implantation.

Some of the more prominent mesh manufacturers and their products include:

• Mentor Corporation (unit of Johnson & Johnson): Obtape Transobturator Sling
• C.R. Bard: Align, Avaulta Plus, Avaulta Solo Synthetic Support System, Faslata Allograft, Pelvicol Tissue, Pelvitex Polypropylene Mesh, Pelvilace, Uretex and Ugytex
• Johnson & Johnson/Ethicon: Gynecare Prolift, Gynecare Prosima, Gynecare TVT Sling, Gynemesh PS, Gynecare Prolene Mesh
• Cook Medical: Surgisis Biodesign Sling & Floor Graft, Stratasis Urethral Sling
• Boston Scientific: Obtryx Mesh, Pinnacle, Advantage Sling System, Lynx Sling, Prefyx PPS System
• American Medical Systems (AMS): BioArc, Elevate, SPARC, In-Fast, Apogee, Monarc and Perigree
• Coloplast Corporation:  Aris Transobturator Sling, Supris Suprapubic Sling, T-Sling with Centrasorb, Novasilk, Restorelle, Exair,  Omnisure & Minitape Sling
• Caldera Medical: Ascend Anterior and Ascend Posterior Mesh

FDA warns of health concerns, orders new studies

More than 5,000 reports involving injury and malfunction of transvaginal mesh implants have been logged with the FDA, triggering a stern public safety announcement in 2011.

“The FDA has not seen conclusive evidence that using transvaginally placed mesh in POP repair improves the clinical outcomes any more than traditional repair that does not use mesh, and it may expose patients to greater risks,” cautioned the agency.

Even more disconcerting, federal regulators determined that 10 percent of women experienced serious complications with vaginal mesh within the first year of implantation. These, however, were not linked to any particular brand or model of mesh implant, but were witnessed across the board.

Between 2008 and 2010, 7 deaths were associated with POP transvaginal mesh repairs. At present, vaginal mesh products are considered Class II medical devices within the FDA’s 510(k) clearance process – this means that mesh manufacturers are able to bypass rigorous testing as long as they show that their device is “substantially equivalent” to an existing product on the market.

Owing to the surge in adverse event reports, the FDA sent letters to more than 35 manufacturers in 2012, ordering new clinical trials on the safety and efficacy of pelvic mesh. One of the studies had to be halted prematurely, as transvaginal mesh complications posed too much risk to the patients. The research was supposed to track outcomes over three years but was halted early when vaginal mesh erosion occurred in 15.6 percent of patients, according to the American College of Obstetricians and Gynecologists.

Vaginal mesh implant complications

Thousands of adverse event reports submitted to the FDA show that transvaginal mesh erosion is the most common complication that patients suffer.

The following pelvic mesh injuries have also been reported:

• Return of pelvic organ prolapse (POP)
• Neuro-muscular problems
• Bowel, bladder, and blood vessel perforation
• Urinary problems
• Fistulas
• Vaginal wall narrowing
• Mesh extrusion
• Vaginal scarring
• Bleeding
• Urinary problems
• Pain during sexual intercourse, or dyspareunia
• Excruciating pain
• Infection
• Recurrence of stress urinary incontinence (SUI)
• Organ damage

Some of the more severe vaginal mesh complications require multiple revision surgeries to remove the implant or bladder sling, along with treatment for abscesses, hematomas and septic infections. Blood transfusions, prescription medications and other supportive measures may also be necessary.

While the physical toll of such injuries is obvious, the emotional and psychological hardships suffered by thousands of women paint a particularly tragic picture. A number of women have said that vaginal mesh implants have “ruined their lives,” turning a routine treatment for incontinence into a nightmarish ordeal.

After enduring several corrective surgeries and losing all self-confidence, many women argue that surgical mesh complications destroyed all intimacy with their partners – sometimes undermining an otherwise stable marriage.

Some products pulled off the market

In the shadow of mounting litigation, no manufacturer has implemented a vaginal mesh recall—though several manufacturers have mandated global discontinuations of some of their products.

Johnson and Johnson stopped selling its Gynecare Prolift Pelvic Floor Repair System, Gynecare TVT Secur System and Gynecare Prosima Pelvic Floor Repair System. C.R. Bard pulled its Avaulta line of pelvic mesh products off the market, and Mentor Corporation suspended sales of its controversial Ob Transobturator Sling in 2006.

Meanwhile, product liability lawsuits have been filling up the courts, with so much litigation that cases have been consolidated on the state and federal level.

Defendants in pelvic mesh injury lawsuits

To date, more than 25,000 transvaginal mesh lawsuits have been brought in the United States, with legal experts anticipating hundreds more in the coming months. Women are suing on counts of negligence, strict product liability, misrepresentation and breach of warranties among other causes of action, while their partners are demanding compensation for loss of spousal consortium.

In an effort to streamline the discovery process and ensure uniformity in rulings among similar lawsuits, six coordinated litigations were established before a single judge in the U.S. District for the Southern District of West Virginia.

Transvaginal mesh multidistrict litigations:

• American Medical Systems (MDL. 2325)
• Boston Scientific Corp. (MDL No. 2326)
• Coloplast (MDL No. 2387)
• C.R. Bard (MDL No. 2187)
• Cook Medical  (MDL No. 2440)
• Ethicon/ J&J (MDL No. 2327)

A 7th pelvic mesh has been centralized in U.S. District Court for the Middle District of Georgia, involving cases alleging problems with Johnson & Johnson’s Mentor ObTape sling device.

Settlements and jury awards granted to plaintiffs

Litigation is in various stages in federal and state court, but recent bellwether trials have rendered multi-million dollar verdicts for some plaintiffs. This past August, Donna Cisson made legal news when she won a $2 million verdict in her case against C.R. Bard.  Bloomberg reports that Bard also reached a vaginal mesh settlement – for an undisclosed sum – with a plaintiff whose case was slated for trial in Atlantic City superior court. Insiders told Bloomberg that a handful of defendants, including Boston Scientific, Bard and Endo Health Solutions, may be participating in behind-the-scene settlement talks, to avoid costly payouts if cases are lost at trial.

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