FDA Send Endo Warning Letter Over Vaginal Mesh Facility

FDA_warns_endo_transvaginal_mesh_facilityFollowing an inspection by federal regulators, pharmaceutical firm, Endo International PLC, was sent a warning letter by the U.S. Food and Drug Administration (FDA) over issues discovered at a vaginal mesh facility.

The inspection was conducted at an Endo subsidiary’s Minnesota facility, Endo wrote this week in a regulatory filing with the U.S. Securities and Exchange Commission (SEC), according to Law360. Endo wrote that the April 10 warning letter came after issues were identified by the FDA following an inspection of a Minnetonka, Minnesota facility operated by its subsidiary, American Medical Systems Inc. (AMS).

The FDA’s inspection found three issues that, according to Endo, it self-identified. Endo also indicated that it put a corrective action plan in place and that the plan is expected to be completed after February 2015, according to the SEC filing, wrote Law360. Endo then responded to the FDA with an “accelerated” plan asserting its commitment to fully comply with all laws and regulations, it indicated.

The FDA sent AMS a warning letter, despite the corrective action plan, that indicated that it had reviewed the plan; however, many actions were still open and would require validation through future inspections, according to the filing, Law360 reported. Addressed issues involve process validation, risk analysis, and corrective and preventative actions, according to AMS.

AMS did indicate that it is in the process of drafting a response to the warning letter and also continues to implement its plan; AMS has 15 days to respond to the agency. Meanwhile, AMS is facing thousands of lawsuits in a multidistrict litigation (MDL) brought over its vaginal mesh products and is the subject of a number of state probes, as well. Endo reported having received subpoenas investigating its pelvic mesh products, according to Law360. Last June, AMS agreed to pay $54.4 million to settle some lawsuits that were brought over its vaginal mesh products and which resolved an unspecified number of claims, Law360 noted.

Meanwhile, the FDA has ordered 33 pelvic implant makers to study organ damage and complication rates related to the pelvic devices, wrote Bloomberg Businessweek in a prior report. In 2010, alone, over 70,000 pelvic implant devices had been implanted in women nationwide.

The FDA has indicated that complications associated with vaginal mesh implants are “not rare,” and warned that use of these devices may be more harmful when compared to alternative methods. The agency also recently reported that the most common adverse reactions linked to the pelvic devices may include: Bleeding; dyspareunia (pain during sexual intercourse); exposure, extrusion, or protrusion (mesh erosion through the vagina); infection; organ perforation; pain; and urinary problems.

Pelvic mesh devices are threaded through incisions made in the vagina and are implanted to strengthen the muscles of the pelvic floor, which may weaken due to age, childbirth, and other reasons. The devices help to support internal organs or treat incontinence involved in diagnoses including pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

In 2013, a jury ruled that J&J had to pay $11.1 in damages involving alleged injuries due to its Prolift device in the first case over any of these implants to reach trial, Bloomberg Businessweek wrote.

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