Parker Waichman Representing Colorado Woman in AMerican Medical Systems Transvaginal Mesh LawsuitMay 25, 2012 | Parker Waichman LLP
A Colorado woman is the latest to file a lawsuit against the makers of a transvaginal mesh surgical device, claiming it has led to a series of painful and life-altering complications.
The woman is being represented by the national law firm of Parker Waichman LLP, which currently represents several other women who’ve been seriously injured and incurred rising medical costs after receiving a transvaginal mesh device to treat either Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP). The lawsuit was filed this week in U.S. District Court for the Northern District of California.
According to a release announcing the filing of the lawsuit, the Colorado woman received the American Medical Systems' Perigee System with InteXen LP and the Apogee Systen with InteXen LP during a surgical procedure in May 2010 to treat conditions brought on by both SUI and POP. Since that surgery, the woman has suffered myriad complications caused by the defective transvaginal mesh devices, including “significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, and loss of bodily organ systems.” Since that initial surgery, she has been forced to endure fruitless revision surgeries and continues to suffer pain and discomfort.
American Medical Systems is facing dozens of lawsuits filed by women who’ve also received transvaginal mesh devices in surgeries to repair these common problems. Many of those federal lawsuits have already been consolidated as part of Multidistrict Litigation against the company in U.S. District Court for the Northern District of West Virginia. This company, along with more than 30 other manufacturers of transvaginal mesh devices are likely to face thousands of lawsuits filed by women injured by these devices, which were not properly tested for safety prior to being approved for use in surgeries by the Food and Drug Administration. Because these devices are similar to other surgical mesh products used for years in other procedures, the makers of transvaginal mesh devices used this fact to get them approved through the agency’s 510(k) “fast-track approval” system. American Medical Systems’ devices were approved through that process.
Since the beginning of 2008 however, the agency has received nearly 3,000 adverse event reports from women who’ve been injured by transvaginal mesh devices. This has prompted a Congressional inquiry in which lawmakers have required the 33 makers of transvaginal mesh devices to conduct full post-market safety studies on their products. Last year, the FDA updated its stance on transvaginal mesh devices and determined that it’s uncertain whether women are experiencing any clinical benefit from these devices. It also ruled that injuries caused by transvaginal mesh devices were not “uncommon” as it had previously determined.
In her lawsuit, the Colorado woman claims she’s suffered myriad complications, including ‘vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess.”