Serious Injuries Caused By Two Transvaginal Mesh Implant Pelvic Devices. Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit naming C.R. Bard, Inc. as Defendants. The suit alleges that two transvaginal mesh implants manufactured by the company caused serious injuries to a Kentucky woman. Parker Waichman filed the suit on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03106) where it is one of many cases pending in the multidistrict litigation as part of the In Re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No 2187).
According to the Complaint, the Plaintiff was implanted with the Pelvitex Polypropylene Mesh and the Uretex TO2 Trans-obturator Urethral Support System in January 2006. Along with thousands of other women around the country, the Plaintiff received the pelvic devices in order to correct her pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP is when the organs of the pelvis slip out of place and bulge, or prolapse into the vagina while SUI causes the involuntary release of urine during activities such as laughing or sneezing. These conditions tend to be more common among women who have given birth. Transvaginal mesh attempts to correct POP and SUI by providing extra support to the pelvic walls. According to the lawsuit, however, the devices have only caused painful injuries.
Material Used in The Mesh is Not Inert
The suit alleges that the material used in the mesh is not inert, meaning that it is able to react with the body’s tissues. This, the lawsuit alleges, can lead to an increased risk of vaginal erosion, where the mesh migrates from its original location and cuts through other tissues and organs. The mesh implants also allegedly pose an increased risk of infection, extrusion, perforation, chronic pain and/or abscess.
According to the lawsuit, transvaginal mesh devices were not properly tested for safety because they were approved through 510(k), an approval process that allows devices onto the market without any formal review so long as the manufacturer can prove that it is similar enough, or “substantially equivalent” to a device that has already been approved. Last summer, the U.S. Food and Drug Administration (FDA) said that complications associated with transvaginal mesh are “not rare.” The agency said that the most common complaints between 2008 and 2010 included mesh erosion, pain, infection, bleeding, painful intercourse, organ perforation and urinary problems. Last September, an FDA advisory panel recommended that transvaginal mesh implants be reclassified from “moderate” to “high” risk, a designation that would force manufacturers to conduct safety tests in order to obtain approval.
In July, C.R. Bard lost the first lawsuit over transvaginal mesh. According to Bloomberg News, the company is said to pay $5.5 million to a California couple who alleges injuries and complications from the Avaulta Plus.