After several years of complaints and lawsuits filed by tens of thousands of women claiming they sustained serious injuries as a result of having pelvic mesh devices implanted, the federal government is taking new aim at establishing and enforcing guidelines for medical device companies.
The US Food and Drug Administration (FDA) is recategorizing vaginal mesh products as “high-risk” medical devices. Prior to the FDA’s recent announcement about new regulations, the implants were labeled as “moderate risk” devices.
Major drugmakers, such as Endo International, Boston Scientific and Johnson & Johnson, are all makers of plastic mesh devices which are surgically implanted as a treatment for pelvic organ prolapse. The mesh devices are meant to strengthen the pelvic wall when a woman is having issues with constipation, pain or urinary problems. The devices can be implanted vaginally with a small incision or abdominally with a larger incision. The former was thought to speed recovery and, therefore, was preferred by some patients.
However, many women are having significant problems with these mesh devices — hence the lawsuits. In fact, Endo agree to a personal injury class action settlement that amounts to $830 million for more than 20,000 people. The other drug makers are facing similar lawsuits.
Apparently, the problems have arisen in women who had the devices implanted vaginally. The FDA is seeking to apply more stringent guidelines for all mesh products that can be implanted vaginally. Those devices that are surgically implanted with an abdominal incision are not included in the new guidelines. Also, medical devices implanted to treat incontinence or hernias are not included in the guidelines, either.
According to the FDA, pelvic mesh manufacturers must “submit new applications demonstrating the safety and effectiveness of their products.” Now, any company that currently has a mesh device on the market will have to answer to the FDA regarding the safety and efficacy of those products or potentially face government penalties, as well as a product liability lawsuit. Other companies looking to introduce similar products will have to go through a revised FDA application process before obtaining approval.
For more information on the FDA’s move to better regulate pelvic mesh devices, read the NY Times article, “FDA Sets New Rules for Injury-Prone Pelvic Mesh.”
When you or someone you love has been injured because of a doctor’s negligence or due to a faulty medical device, we invite you to bring your case to the experienced and compassionate attorneys at Andres, Berger & Tran. We will fight for maximum compensation and get you the justice you deserve. Contact us today for a free consultation.