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FDA Warns Endo Over Vaginal Mesh Facility

Apr 17, 2014

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

The inspection took place at an Endo subsidiary’s Minnesota facility, wrote Endo in a regulatory filing with the U.S. Securities and Exchange Commission (SEC) this week, according to Law360. According to Endo, the April 10 warning letter followed up on issues identified by the agency after an inspection of a Minnetonka, Minnesota facility operated by its subsidiary, American Medical Systems Inc. (AMS).

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

Despite the corrective action plan, the agency sent AMS a warning letter indicating that it had reviewed the corrective action plan; however, many of the actions remained open and will require validation through future inspections, according to the filing, Law360 reported. Addressed issues are associated with process validation, risk analysis, and corrective and preventative actions, according to AMS.

AMS indicated that it is in the process of drafting a response to the warning letter and s also continuing to implement its plan. AMS has 15 days to respond to the agency. Meanwhile, AMS is facing thousands of lawsuits in multidistrict litigation (MDL) brought over its vaginal mesh products and is also the subject of a number of state probes. 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 involving its vaginal mesh products which resolved an unspecified number of claims, Law360 noted.

Meanwhile, the FDA has ordered 33 pelvic implant makers, including to study organ damage and complication rates related to the pelvic devices, wrote Bloomberg Businessweek in a previous 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 has 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 these 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 that are 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.

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