Transvaginal Surgical Mesh Risks Highlighted in PBS Report
A recent report on PBS highlights the problems transvaginal mesh products are causing for many women throughout the U.S., detailing how these devices were introduced without clinical studies by exploiting the FDA’s 510(k) fast-track medical device approval process.
The lawyers at Saiontz & Kirk, P.A. represent women who are pursuing product liability lawsuits against the manufacturers for failing to adequately warn about the transvaginal surgical mesh risks. The March 22nd segment on “Need to Know” on PBS provides a clear example of the devastating and life-changing impact these products can have on a woman’s quality of life:
The episode presents the story of Linda Gross, a South Dakota mother and former nurse who was implanted with a Ethicon Gynecare Prolift vaginal mesh. She developed severe complications that required numerous surgeries, destroyed her ability to have intercourse with her husband, caused her to have to quit her job and left her permanently injured and in pain.
In February, a jury awarded Gross more than $11 million in compensatory and punitive damages after she filed a product liability lawsuit against Ethicon, a Johnson & Johnson subsidiary that manufactured the device. The case was one of the first complaints over transvaginal mesh to reach a jury, and a series of additional trials are scheduled in the federal transvaginal mesh litigation over the next 18 months, which may set the tone for eventual negotiations to settle vaginal mesh cases.
Other portions of the PBS program highlight the need for a new regulatory framework for the approval of medical devices. The show points out that some countries, like Australia, have registries for certain medical devices that track problems, allowing early warning when complications appear to be commonplace. Similar registries are in place in Europe.
In Australia, a hip implant registry noticed metal-on-metal hip replacement systems had a high failure rate and an alarming number of complications, leading doctors there to avoid using them years before doctors in the U.S. realized there was a problem, according to the program.
However, the medical device manufacturing industry is resisting any attempts to reform the 510(k) process or to require more stringent clinical testing of devices before they go to the market, claiming that such efforts at improved patient safety would choke innovation and drive costs up.
TRANSVAGINAL MESH LAWSUITS
For women who have suffered complications from transvaginal surgical mesh used to repair pelvic organ prolapse or stress urinary incontinence, financial compensation may be available as a result of the manufacturer’s failure to properly research their products or warn about the risk of problems.
The lawyers at Saiontz & Kirk, P.A. are reviewing individual lawsuits nationwide for women implanted with mesh products from:
- American Medical Systems
- Boston Scientific
- C.R. Bard
- Cook Medical
All cases are handled on a contingency fee basis, meaning there are no fees unless a recovery is obtained. If you, a friend or family member has suffered vaginal mesh complications, request a free consultation and claim evaluation.