According to a July 13, 2011, FDA safety alert, complications linked to transvaginal mesh implants are “not rare” and the use of such devices may actually be more harmful compared to alternative methods for treating POP.
New York, New York (PRWEB) July 01, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by dangerous drugs and medical devices, has filed a lawsuit on behalf of a Texas woman who alleges that she was injured by transvaginal mesh products. The suit was filed 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 was implanted with the Novasilk-Synthetic Flat Mesh in May 2011, the Alyte Y-Mesh in October 2012 and the TVT Exact in October 2012. These devices were implanted to treat the Plaintiff’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The lawsuit alleges that these devices are defective and caused serious and possibly permanent injuries. Furthermore, the Defendants allegedly knew about these defects but did not warn consumers in order to protect their own financial interests. The Plaintiff is suing for pain and suffering, emotional distress, and economic loss, and is seeking compensation for punitive damages.
The U.S. Food and Drug Administration (FDA) reports 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
According to a July 13, 2011, FDA safety alert, complications linked to transvaginal mesh implants are “not rare” and the use of such devices may actually be more harmful compared to alternative methods for treating POP. The FDA has also asked 33 manufacturers, including Johnson & Johnson, to conduct post-market safety studies in order to investigate the effect of vaginal mesh on organ damage and other health concerns. (http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm)
Thousands of transvaginal mesh lawsuits have been filed in the United States. Many have been consolidated into five MDLs now pending in U.S. District Court for the Southern District of West Virginia. The other MDLs are: In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2325; In Re: Boston Scientific Products Liability Litigation, MDL No. 2326; In Re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2187 and In Re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2327.
The first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict in favor of the Plaintiff (Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey), according to a Feb. 28, 2013, Bloomberg report. The Plaintiff’s case was the first of 4,000 Gynecare Prolift cases expected to go to trial. Johnson & Johnson was ordered to pay $3.35 million in compensatory damages and $7.76 million for punitive damages. (http://www.bloomberg.com/news/2013-02-28/j-j-owes-7-76-million-in-punitives-in-vaginal-mesh-case.html)
Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with mesh, please visit the firm's transvaginal mesh injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney