The FDA is doubling down on transvaginal mesh devices, responding to growing safety concerns by slapping the products with its most serious designation and calling for additional information from manufacturers before signing off on related devices.
The agency is reclassifying surgical transvaginal mesh devices for pelvic organ prolapse (POP) from Class II to Class III, which is typically reserved for high-risk devices. Regulators are also requiring that manufacturers submit a premarket approval (PMA) application "to support the safety and effectiveness" of their products, the FDA said in a statement.
Companies that already have products on the market have 30 months to submit a PMA application, and manufacturers with new products will need to submit a PMA before the FDA gives its stamp of approval. But the latest requirements don't apply to mesh products used to treat other conditions such as urinary incontinence.
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| CDRH's William Maisel |
Heightened scrutiny for the devices "will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, head of the FDA's Center for Devices and Radiological Health, said in a statement. And the agency plans to keep up its oversight, saying that it will "continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures," Maisel said.
The latest action builds on the FDA's previous attempts to crack down on mesh devices. The agency has gotten "thousands" of reports of complications related to mesh for transvaginal POP repair, regulators said in a statement, including severe pelvic pain, pain during intercourse, bleeding and urinary issues if the mesh erodes into surrounding tissues. Taking this into consideration, the FDA has recently beefed up its oversight of the products.
In 2008 and 2011, the FDA issued safety communications to doctors and consumers about a spike in adverse event reports tied to mesh used for urogynecological procedures. Regulators also convened a panel of experts in September 2011 to discuss how it should regulate transvaginal mesh devices. The panel's recommendations prompted the agency to order manufacturers to conduct postmarket surveillance studies for the devices. In 2014, the FDA laid out its plan to reclassify the devices as Class III and to require companies making the products to submit a PMA application.
Meanwhile, women who suffered from faulty mesh products continue to strike back at manufacturers of the devices. Industry giants such as Johnson & Johnson ($JNJ) and Boston Scientific ($BSX) are facing thousands of suits from women who claim that the company's devices caused them pain and injury, scoring few victories along the way. In April, Boston Scientific shelled out $119 million to settle about 3,000 cases over mesh products.
Other companies including Endo International ($ENDP) are taking a different route, settling all outstanding rather than battling it out with plaintiffs in court. In 2014, Dublin-based Endo added $400 million to its legal stockpile to settle "substantially all" of suits regarding mesh products sold by its American Medical Systems (AMS) unit.
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