The U.S. Food and Drug Administration (FDA) has rejected a request from the safety advocacy group Public Citizen to order recalls of vaginal mesh products and ban their future sale.
According to a Law360 news report, the letter released Monday said a recent proposal, which is expected to “rigorously review” these controversial surgical mesh products is enough for now.
Public Citizen filed the petition in 2011 asking that these dangerous and defective products be recalled and removed from the market.
However, in its response to the petition, FDA officials said it proposed earlier this year to require premarket approval for surgical mesh products used to repair conditions such as pelvic organ prolapse and stress urinary incontinence.
These mesh implants have been the target of thousands of product liability lawsuits nationwide. Plaintiffs have alleged serious side effects from chronic pain and incontinence to nerve damage.
For years, these devices have been cleared for sale along the less stringent 510 (k) approval process.
Serious Side Effects
Consumers have certainly paid the price in these cases. Our law firm has heard the stories of many women who have suffered significant side effects.
Many are unable to sit down, walk, work, earn a living or even have intimacy with their partners. This has turned so many lives upside down.
The FDA first voiced its concerns only in 2008 and it could be several more years from now before its proposed order on premarket approvals is finalized and new clinical trials are performed to gauge whether these products should stay on the market.
For thousands of women around the country though, the damage has been done. Their lives have been changed forever.
Protecting Consumers’ Rights
Medical device manufacturers such as C.R. Bard, Johnson & Johnson and Boston Scientific have, over the years, put these mesh products in the market without proper testing – because they could.
We learned during the civil trials that the companies aggressively marketed these devices to women promising to cure their problems and give them permanent relief. A number of women even testified they were not informed about the risks, but were instead told that it would be minimally invasive and have minimal risk.
If you have suffered severe side effects as a result of these vaginal mesh devices, please contact an experienced defective vaginal mesh lawyer who will fight for your rights and ensure that the negligent manufacturers are held liable.
Our legal team has successfully represented injured clients in hundreds of defective products and we may be able to help you too.