Boston Scientific is a manufacturer of bladder slings and other transvaginal mesh devices designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The FDA first approved Boston Scientific vaginal mesh devices in 1996.
Popular Boston Scientific transvaginal mesh products include the Transobdurator Obtryx Sling and the Advantage Transvaginal Mid-Urethral Sling System, polypropylene mesh devices designed to treat SUI. Bladder slings work by creating a pelvic hammock around the bladder and urethra to keep them closed during normal activities.
Boston Scientific also manufactures pelvic organ prolapse kits, such as the Pinnacle® Pelvic Floor Repair products, which were introduced in 2004 and marketed as a risk free solution to POP. However, women across the country are coming forward with lawsuits alleging that they have suffered through myriad complications from defective Boston Scientific vaginal mesh devices.
The FDA estimates that as of 2010, over 300,000 women had undergone implantation of vaginal mesh devices, and thousands of adverse event notices had been filed.
Boston Scientific Transvaginal Mesh Products
- Pinnacle® Anterior-Apical Pelvic Floor Repair Kit
- Pinnacle® Posterior Pelvic Floor Repair Kit
- Pinnacle® Duet Pelvic Floor Repair Kit
- Boston Scientific Uphold Vaginal Support System
- Boston Scientific Obtryx® Transobturator Mid-Urethral Sling System
- Boston Scientific Advantage Transvaginal Mid-Urethral Sling System
Serious Complications from Boston Scientific Mesh Products
The FDA reports that the material used in vaginal mesh products, such as Boston Scientific’s Pinnacle® Pelvic Floor Repair Kits, Uphold Vaginal Support System, Obtryx® Transobturator Mid-Urethral Sling System, and Advantage Transvaginal Mid-Urethral Sling System, can cause serious complications – such as mesh erosion and mesh contraction – that can be debilitating for some women. According to the reports, these complications are “not rare” and can lead to infection, recurrence of pelvic organ prolapse, and vaginal scarring among other adverse effects. Affected patients must often undergo multiple corrective surgeries in an attempt to remove defective devices and repair the damage caused by the mesh. However, in many cases, it is impossible remove all of the pieces of a defective sling or mesh system.
According to the current lawsuits pending against Boston Scientific, the manufacturer knew of the serious risks associated with the Pinnacle® Pelvic Floor Repair Kits, Uphold Vaginal Support System, Obtryx® Transobturator Mid-Urethral Sling System, and Advantage Transvaginal Mid-Urethral Sling System, but failed to disclose those risks to patients and doctors. Women across the country are bringing suits against Boston Scientific to recover for the pain and suffering caused by Boston Scientific’s alleged negligent design and failure to warn of the risks associated with its vaginal mesh.
FDA Warnings and Multidistrict Litigation
Starting in 2008, the FDA issued a series of FDA health warnings and an FDA safety communication warning of the injuries and complications that can occur through the use of transvaginal mesh products. While there has been no formal recall of Boston Scientific’s vaginal mesh products, the FDA is now requiring Boston Scientific and other manufacturers to conduct safety studies to determine the rate of serious injuries associated with their vaginal mesh products.
Boston Scientific is one of the medical manufacturers, along with C.R. Bard and Johnson & Johnson, named in the five multidistrict litigation trials regarding transvaginal mesh injuries currently pending in U.S. District Court, in the Southern District of West Virginia. As of July 2013, more than 5300 cases have been filed against the manufacturer. See MDL No. 2326 Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation.
Injured by Transvaginal Mesh? Free consultation.
Our transvaginal mesh lawyers represent women nationwide who have suffered injuries from vaginal mesh implants. If you or a loved one suffered vaginal mesh injuries, you may have a legal right to financial compensation. For a free and confidential consultation about your possible transvaginal mesh lawsuit, please fill out the form to the right or call (866) 981-4800.
Women Representing Women
Ms. A. J. De Bartolomeo, a partner at Gibbs Law Group, represents women injured after using transvaginal mesh as well as Mirena and NuvaRing birth control products, and serves on the Plaintiffs’ Steering Committees for the Yaz and Yasmin Birth Control and Pradaxa lawsuits. Our personal injury attorneys have also represented those injured by Medtronic medical devices, Sprint Fidelis leads, SSRIs, Actos, and GranuFlo. We have recovered settlements worth hundreds of millions for our clients.
Our law firm has decades of experience successfully representing people injured by some of the nation’s largest and most powerful corporations. Our attorneys pride themselves on being there for our clients at every stage of the litigation from intake through verdict or settlement.