FDA Reclassifies Transvaginal Surgical Mesh Used To Repair Pelvic Organ Prolapse As High-Risk Medical Device

162017_132140396847214_292624_nOn January 4, 2016, the FDA announced that it was issuing two final orders regarding surgical mesh used to transvaginally repair pelvic organ prolapse (POP). One final order reclassified transvaginal surgical mesh used to repair POP from a Class II medical device (moderate-risk medical devices) to a Class III medical device (high-risk medical devices), and the other final order requires manufacturers of surgical mesh to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh used for transvaginal repair of POP before those medical devices can be approved for marketing.

Manufacturers of surgical mesh used to treat transvaginal POP that are already on the market will have thirty months to submit a PMA for those medical devices.

The FDA’s orders apply only to surgical mesh used for transvaginal repair of POP, and do not apply to surgical mesh used for stress urinary incontinence (SUI) or for abdominal repair of POP.

Surgical mesh has been used in the United States for transvaginal repair of POP since the 1990s (surgical mesh has been used in the United States for abdominal repair of POP since the 1970s, and surgeons in the United States have been using surgical mesh to repair abdominal hernias since the 1950s).

The FDA’s most recent orders regarding surgical mesh come after an advisory panel of experts in 2011 recommended that more data was necessary to establish the safety of the medical device. The FDA had previously warned physicians and patients in safety communications issued in 2008 and in 2011 about an increase in adverse event reports related to surgical mesh used for urogynecological procedures. The FDA had issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP. The FDA’s new orders follow two proposed orders in May 2014, to reclassify the devices from class II to class III medical devices and to require manufacturers to submit a PMA application.

In announcing the new FDA orders, the deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health stated, “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

Source

Many lawsuits have been filed in the United States against manufacturers of surgical mesh used to treat POP, alleging that patients have suffered substantial harm, including severe pelvic pain and organ perforation. On May 28, 2015, a Delaware jury awarded the plaintiff $100 million ($25 million in compensatory damages and $75 million in punitive damages) against the manufacturer of the transvaginal mesh that was implanted in the plaintiff that she alleged was defective and caused her to suffer vaginal scarring and other serious medical conditions due to alleged erosion of the surgical mesh following her surgery.

If you or a family member were implanted with vaginal mesh or other surgical mesh and suffered complications, injuries, or chronic pain afterwards, you should find a mesh claim lawyer in your U.S. state who may investigate your surgical mesh claim for you and represent you in a claim against the manufacturer, distributor, and/or supplier of the surgical mesh, if appropriate.

Visit our website to submit a short, secure form, or call us toll-free in the United States at 800-295-3959, to find surgical mesh claim attorneys who may assist you.

Turn to us when you don’t know where to turn.

This entry was posted on Tuesday, January 5th, 2016 at 5:15 am. Both comments and pings are currently closed.

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