A Texas woman who alleges that she was injured by transvaginal mesh products made by Coloplast Corp. has filed a lawsuit against the company.
The suit was filed on her behalf on June 10, 2013, in the U.S. District Court for the Southern District of West Virginia (Case No. 2:13-cv-11164) in the multidistrict litigation (MDL) entitled In Re: Coloplast Corp., Pelvic Support System Products Liability Litigation (MDL No. 2387). Mentor Worldwide LLC, Coloplast Corp., Ethicon, Inc., Ethicon, LLC, Johnson & Johnson and C.R. Bard, Inc. have been named as Defendants.
According to the complaint, the plaintiff received three implants to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI): the Novasilk-Synthetic Flat Mesh in May 2011, the Alyte Y-Mesh in October 2012 and the TVT Exact in October 2012. The lawsuit alleges that these devices are defective and caused her serious and possibly permanent injuries. Further, the suit alleges, the defendants knew about these defects but did not warn consumers in order to protect their own financial interests. The woman is suing for pain and suffering, emotional distress, and economic loss, and is also seeking punitive damages.
A number of complications associated with transvaginal mesh have been reported to the U.S. Food and Drug Administration (FDA). These include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Pain
- Infection
- Bleeding
- Pain during sexual intercourse (dyspareunia)
A July 2011 FDA safety alert warns that complications linked to transvaginal mesh implants are “not rare” and the use of such devices may actually be more harmful than alternative methods for treating POP. The FDA has asked 33 manufacturers, including Johnson & Johnson, to conduct post-market safety studies to investigate organ damage and other health concerns associated with transvaginal mesh devices (http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm).
The Texas woman’s case was filed on her behalf by Parker Waichman LLP and is one of thousands of transvaginal mesh lawsuits now pending in five MDLs in U.S. District Court for the Southern District of West Virginia.
