FDA Warns Endo’s Transvaginal Mesh Unit About Follow-Up Inspection
Endo Pharmaceuticals received a warning letter from the FDA about one of its American Medical Systems transvaginal mesh manufacturing facilities.
The Minnesota-based facility reportedly needed further corrections and updates, according to a recent FDA inspection. The transvaginal mesh manufacturing facility had been inspected in February 2013, at which time the FDA noted that the facility needed to make some changes.
The most recent inspection showed that the updates to the AMS transvaginal mesh facility were incomplete.
Endo Pharmaceuticals, which faces thousands of personal injury cases related to its transvaginal mesh products, received a warning letter from the FDA regarding the manufacturing facility and will receive another follow-up inspection. In the meantime, the company is allowed to continue to manufacture transvaginal mesh items at the facility.
However, the issue could result in higher expenses for Endo, which already faces massive costs in its transvaginal mesh litigations.
Endo Sets Aside $520 Million for Transvaginal Mesh Litigation
The medical manufacturer reported in February that it had set aside $520 million to settle the remaining transvaginal mesh lawsuits, although so far the company has not proposed that settlement amount in court.
A securities filing from the company noted that Endo had increased its product liability pool to $520 million at the end of last year.
“The increase in our reserve reflects management’s ongoing assessment of our product liability portfolio, including the vaginal mesh cases, the status of the company’s ongoing settlement discussions related to vaginal mesh litigation and the inherent uncertainty as to the ultimate costs of resolving this litigation,” Endo said.
Endo officials also stated that the amount would cover not only settlement deals, but judgments and legal defense related to the transvaginal mesh lawsuits.
The Strom Law Firm Represents Women in Transvaginal Mesh Personal Injury Cases
Transvaginal mesh was originally developed in 1996 and approved by the FDA for organ prolapse that caused vaginal pain and stress urinary incontinence. The original transvaginal mesh, Boston Scientific’s ProtoGen, was recalled in 1999, but due to an FDA approval loophole called 510(k) – which fast-tracks approval of devices similar to previously-approved devices – many other medical manufacturing companies began developing transvaginal mesh devices of their own.
Recently, due to the high number of personal injury claims involving transvaginal mesh devices, CR Bard, Endo Health Solutions, Boston Scientific, Coloplast, and Cook Medical, began settlement talks. Reportedly, these five transvaginal mesh manufacturers faced a total of 30,000 personal injury lawsuits. Johnson & Johnson, meanwhile, has not agreed to any settlement talks and will continue facing bellwether trials in its MDL in Virginia.
It is important to hold medical manufacturers, including manufacturers of transvaginal mesh, to the highest ethical standard. If you or a loved one have had surgery involving transvaginal mesh, and have since suffered painful side effects including bleeding, infection, organ perforation, and constant pain in the lower extremities, you may be entitled to compensation. The attorneys at the Strom Law Firm understand the suffering caused by defective devices like transvaginal mesh, and can help with your case. We offer free, confidential consultations to discuss your concerns, so do not hesitate to contact us. 803.252.4800.