Thousands of women have been implanted with transvaginal mesh devices to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many women implanted with these devices are reporting complications allegedly related to their defects. SUI and POP are conditions most commonly caused by weakened pelvic muscles. The devices are meant to help correct these conditions by providing additional strength to the pelvic walls.
Now, another woman alleges that her transvaginal mesh device is defective and caused her serious injury. The California woman has brought a lawsuit against transvaginal device maker, Boston Scientific Corporation.
The woman was implanted with Boston Scientific Corp.’s Advantage Fit System on June 18, 2009. The lawsuit alleges that the mesh device was defective; had a flawed design that caused the woman serious, and possibly permanent, injuries; and that Boston Scientific Corp. was aware of the dangers of its product, but chose not to warn consumers.
Thousands of transvaginal mesh lawsuits have been formulated into six multidistrict litigations (MDLs) pending in U.S. District Court for the Southern District of West Virginia:
- In Re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2327
- In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325
- In Re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2187
- In Re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation, MDL No. 2326
- In Re: Coloplast Corp., Pelvic Support Systems Products Liability Litigation, MDL No. 2387
- In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2440.
The U.S. Food and Drug Administration (FDA) stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful compared to alternative methods for treating POP. The FDA also reported on July 13, 2011, that the most common complications associated with transvaginal mesh may include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
The vaginal mesh devices were approved through an FDA expedited process, known as the 510(k), under which a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for transvaginal mesh and other controversial devices, the process has drawn increasing criticism. An array of companies—Boston Scientific, Endo Health Solutions, Cook Medical, and Johnson & Johnson’s Ethicon subsidiary—face about 4,000 federal lawsuits over their transvaginal mesh devices, according to MassDevice.com.
National law firm, Parker Waichman LLP, filed this lawsuit on July 10, 2013, in the U.S. District Court for the Southern District of West Virginia in the MDL brought against Boston Scientific Corp.