The FDA went on to say that most cases of POP can be successfully treated without transvaginal mesh.
(PRWEB) August 08, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who allegedly experienced painful and disfiguring symptoms after being implanted with the Monarc Subfascial Hammock and Apogee System with Intepro. The lawsuit alleges that the transvaginal mesh products caused injuries, and holds the Defendants, American Medical Systems, Inc., responsible for failing to warn about the dangers associated with the device. The suit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03173). There, it is among the many cases filed into the multidistrict litigation known as the In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325).
According to the Complaint, the Plaintiff was implanted with the Monarc Subfascial Hammock and Apogee System with Intepro in July 2005. The mesh was used to treat her pelvic organ prolapse and stress urinary incontinence, the two uses for which the devices were approved, marketed and sold. The lawsuit alleges that the devices caused the Plaintiff to suffer significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and the loss of her bodily organ system.
The lawsuit also alleges that the Defendants failed to warn about the risks associated with transvaginal mesh. According to the complaint, the mesh is not inert and reacts with the body. This, the suit states, can lead to a host of adverse health consequences including:
- Vaginal erosion (also known as exposure, extrusion or protrusion)
- Organ perforation
- Chronic pain and/or abscess
The lawsuit holds the Defendants responsible for exposing women to these risks, especially since they were allegedly aware of such complications.
The U.S. Food and Drug Administration (FDA) has ordered American Medical Systems and 32 other manufacturers to study the impact of transvaginal mesh on organ damage and other health issues. Last July, the agency said that the mesh has no clear advantage over non-mesh methods for treating pelvic organ prolapse even though it may present additional risks. The FDA went on to say that most cases of POP can be successfully treated without transvaginal mesh.
Recently, a California couple won the first personal injury lawsuit over transvaginal mesh; the landmark verdict awarded the couple a total of $5.5 million in a suit alleging C.R. Bard’s Avaulta Plus caused serious complications.
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 transvaginal mesh, please visit the firm's transvaginal mesh injury page. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney