If there's one device that global medical device regulators have spent much of the last year worrying about, it's breast implants. But now, and with a nod to safety critics, US regulators have approved a fourth breast implant product for marketing in the US.
Late in 2011, French regulators began to receive reports that breast implants manufactured by Poly Implant Prothese (PIP) were failing at an alarmingly high rate. The ensuing fallout was in many ways the catalyst for an EU-wide movement that is threatening to do away with the current paradigm for medical device clearances.
US regulators were spared this scandal, due in equal parts to luck and due diligence. The US Food and Drug Administration (FDA) first approved breast implants in 1962, but in 1988 reclassified them as a Class III high-risk medical device product. Just four years later, in 1992, FDA issued a moratorium on new approvals after finding that there was "inadequate information to demonstrate that breast implants were safe and effective."
After a 1999 study conducted by the Institute of Medicine (IOM) found the devices to be safe, FDA lifted its moratorium in 2000 with the approval of a saline-based implant, followed by a silicone-based implant in 2006. By 2000, however, PIP's US marketing distributor, Heritage Worldwide, had withdrawn the product after regulators raised questions about the quality of the company's manufacturing operations in France.
It is against this backdrop that FDA regulators have now approved a new silicone-based gel-filled breast implant product manufactured by Allergan Inc. The product, Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant ("Natrelle 410") is indicated for women 22 years of age and older.
Safety was clearly on the minds of regulators throughout the approval process. Allergan's approval was based on seven years of data-an extensive length of time by most measures.
Allergan will also be required to conduct a large amount of postmarket safety monitoring as a condition of its approval. It will, for example, be required to track at least 3,500 patients for an additional five years, conduct a 10-year study to assess long-term local complications, conduct five case control studies to assess the implants association with five rare diseases, study how patients perceive and understand the device's patient labeling, and analyze any implants that are returned to the manufacturer after being removed from the patient.
Even then, regulators said patients need to have realistic expectations about other safety-related aspects of the device as well.
"It's important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential," said Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH).
FDA said there are now four FDA-approved gel-filled breast implant products on the market, manufactured by Sientra, Mentor and Allergan (two products).