Oregon woman has become the latest to claim she was injured by a defective transvaginal mesh surgical device. An Oregon woman has become the latest to claim she was injured by a defective transvaginal mesh surgical device.
She has joined a growing number of American women who have filed a lawsuit against its manufacturer, claiming the company knowingly hid evidence of its drawbacks while promoting it as safe and effective.
According to a release announcing the filing of her lawsuit, the Oregon woman was implanted with the Elevate transvaginal mesh device during a January 2011 surgery. Soon after that surgery, the woman suffered the same fate as many other women who’ve been implanted with a defective transvaginal mesh device.
Her lawsuit claims that because the Elevate transvaginal mesh device is not inert it does not react well with the tissue in her body and caused her to suffer serious side effects including severe pain, organ damage, and urinary problems. This occurs when the mesh device erodes through the vaginal wall and other areas close to where it was implanted.
A lawsuit was filed on her behalf against the makers and companies responsible for marketing the Elevate transvaginal mesh device, American Medical Systems Inc., American Medical Systems Holdings Inc., Endo Pharmaceuticals Inc. and Endo Health Solutions Inc.
She is being represented by the national law firm of Parker Waichman LLP, which represents numerous victims of transvaginal mesh devices. The firm continues to track the latest developments related to defective transvaginal mesh devices and has filed this latest lawsuit in U.S. District Court for the Southern District of West Virginia.
The lawsuit will be combined with other similar claims as part of a Multidistrict Litigation against the defendants known as the In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325).
FDA warned that injuries caused by transvaginal mesh devices
The Elevate and other transvaginal mesh devices were approved by the Food and Drug Administration to treat painful and disabling conditions known as Stress Urinary Incontinence and Pelvic Organ Prolapse.
These conditions affect tens of thousands of women every year and many have opted to use a transvaginal mesh device like Elevate to rebuild pelvic muscles. Transvaginal mesh devices were approved largely through the FDA’s 510(k) “fast-track” approval system that grants access to the market without requiring pre-market safety testing.
This lawsuit and others believe that companies like American Medical Systems and Endo Pharmaceuticals were aware of the side effects caused by transvaginal mesh devices but failed to warn the public of these dangers.
In July 2011, the FDA warned that injuries caused by transvaginal mesh devices were “not rare” and also ordered makers of these devices to conduct post-market testing to show that their products are safe and effective.