Boston Scientific Transvaginal Mesh

Boston Scientific was a pioneer in the transvaginal mesh market and the company’s first vaginal sling product, Protegen, was approved by the Food and Drug Administration in 1996. Protegen set the precedent for the subsequent release of other vaginal mesh devices by major manufacturers including C.R. Bard and Johnson & Johnson.

Six major manufacturers modeled their own vaginal slings and transvaginal mesh products based on Protegen and used its approval as the basis for obtaining 501(K) clearance from the FDA. The 501(K) clearance process streamlines approval and allows minimal premarket testing when devices are substantially similar to others already approved. These manufacturers are all being sued by injured women, and plaintiffs affected by vaginal mesh products should contact Jeffrey Glassman Injury Lawyers for a confidential consultation to discuss their rights.

Safety concerns caused Boston Scientific to remove the ProtoGen from the market in 1999. However, Boston Scientific has released additional vaginal mesh devices to treat both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Prolapse repair devices and bladder slings manufactured and sold by Boston Scientific include:

• Uphold Vaginal Support System
• Polyform Synthetic Mesh
• Pinnacle Pelvic Floor Repair Kit
• Arise Vaginal Support System
• Advantage Transvaginal Mid-Urethral Sling System
• Prefyx PPS System
• Obtryx Sling System
• Lynx Suprapubic Mid-Urethral Sling System
• Advantage Fit Transvaginal Mid-Urethral Sling System
• Obtryx Transobturator Mid-Urethral Sling

When implanted, the mesh on these products may begin breaking down in the body and serious complications can arise. In 2003, Boston Scientific settled 738 lawsuits from women who alleged complications caused by the Protegen device. Today, the company has thousands more cases pending related to other TVM products.

These claims have been consolidated into a multidistrict litigation (MDL no. 2326) which is currently pending in the Southern District of West Virginia. Multi-district litigations move multiple cases before one judge who can then make a decision only once on common pre-trial issues relevant to all cases.

The first of 6,400 lawsuits in the pending MDL against Boston Scientific are scheduled to go to trial in 2014. The initial cases that progress to trial are considered “bellwether” cases because the outcome can help plaintiffs and the medical device manufacturer evaluate the value of other cases for settlement negotiations.

The parties have been directed to select representative cases, but the plaintiffs who will be included in the bellwether cases must have received only the Obtryx, the Pinnacle, the Uphold system, the Advantage or the Advantage Fit.

Boston Scientific instituted a Class II recall for the Pinnacle Pelvic Floor Repair Kit in 2011 for reasons unrelated to the common problems with vaginal mesh. The recall was driven by fears of a needle detaching during placement. Other than the early Protegen, which was voluntarily removed from the market, other mesh products continue to be sold despite numerous complaints from patients.

By 2010, the Food and Drug Administration had already received more than 4,000 reports of adverse events from mesh devices including pelvic pain, pain during sex, perforation of organs, infection, urinary problems, neuro-muscular problems, vaginal scarring, vaginal bleeding or vaginal shrinkage. In 2012, the FDA issued 522 postmarket surveillance study orders mandating that mesh manufacturers conduct additional testing to determine the safety of mesh products. Some manufacturers including Johnson & Johnson stopped selling certain mesh devices in response, but Boston Scientific has not done so.

Boston Scientific reported a $5 million loss in the third quarter of 2013, and has undergone several rounds of restructuring. In addition to problems with mesh devices, the company has also been facing litigation arising from problems with other medical devices, including implantable defibrillators.

Patients affected by Boston Scientific vaginal mesh products may pursue compensation as part of multidistrict litigation or may pursue individual cases. Call the Jeffrey Glassman Injury Lawyers to discuss your rights.