The U.S. Food and Drug Administration (FDA) has issued a warning to American Medical Systems following a visit to Minnetonka, Minnesota manufacturing plant that makes pelvic mesh devices, which are at the center of thousands of personal injury lawsuits.
The February visit to the plant by FDA officials led to a recent filing with the U.S. Securities and Exchange Commission (SEC). It’s said that the inspectors observed problems “pertaining to process validation, risk analysis and corrective and preventative action procedures.”
According to the SEC filings, American Medical Systems has since taken action to correct the problem by filing an action plan with the FDA. The pelvic mesh manufacturer will reportedly schedule a follow-up inspection so that FDA officials can confirm that corrective measures have been properly implemented.
American Medical System’s transvaginal mesh patches are the subject of approximately 17,000 transvaginal mesh lawsuits, filed by women who claim that they have suffered unnecessary complications following implantation to treat conditions such as pelvic organ prolapse and stress urinary incontinence.
A recent study performed by the FDA revealed that approximately ten percent of all women who had the pelvic mesh implanted suffered serious complications, including infection, internal bleeding, chronic pain, pain during intercourse and erosion of nearby organs and tissues. About half of all women had to undergo at least one follow-up operation due to mesh-related complications.
This week, the FDA issued a proposal that calls for the re-classification of pelvic mesh devices, which are currently listed as a class II moderate risk device.
Under the proposal, which will be open to commentary for a period of 90 days, transvaginal mesh implants would be re-classified as a high risk, class III device. This new classification would result require manufacturers to subject their implants to objective, third-party clinical evaluation. The clinical data would need to be submitted to the FDA for review and approval before the transvaginal mesh implants are made available to the public.
This move by the FDA would serve to ensure safety and efficacy of the implant devices, which originally received a fast-track approval due to their similarity to the mesh implants used to treat hernias.