J&J/Mentor wins U.S. sign-off for silicone breast implant, with conditions

The FDA has signed off on Johnson & Johnson/Mentor's ($JNJ) latest silicone breast implant, a milestone seven years after the agency allowed them to be sold again in the U.S. The company's MemoryShape Breast implant is now the fifth silicone breast to have domestic approval and shares the market here with products made by Allergan ($AGN) and Sientra, regulators note.

Silicone implants were pulled from the market for more than 14 years over safety concerns. The FDA concluded the implants can be safe, but it doesn't mean companies get a free pass. Mentor may be able to start selling its implant, but the company faces a heavy number of approval conditions and requirements, reflecting a rigorous silicone breast approval process in the U.S. that contrasts with the European Union.

In Europe, regulators are now looking at developing tougher medical device approval standards, driven in part by a scandal over substandard silicone breast implants made by the now-defunct French company Poly Implant Prothèse.

Mentor won approval for its tear-drop shaped implant (meant to be more like a natural breast) based on six years of data from 955 women, according to the FDA approval announcement. But the company didn't have a flawless product. Regulators note that it had "similar rates of complications and outcomes as previously approved breast implants," including a need for removal, asymmetry, wrinkling and gel fissures or cracks.

Those 955 women in the pivotal study will continue to be monitored until the company has 10 years of data mapping MemoryShape's safety and effectiveness. Additionally, Mentor will launch a new study involving a whopping 2,500 women with the implants with a focus on gathering 10 years of data about long-term complications such as reoperations or implant rupture and also potential "disease outcomes" like rheumatoid arthritis, cancer or reproductive problems.

And there's more. Among other requirements, regulators want Mentor to pursue five case control studies involving 10,750 women to look at any potential links between silicone breast implants--including the MemoryShape models--and rare diseases such as connective tissue disease, neurological disease, brain cancer and lymphoma. Mentor must also study how women view its patient labeling. And any implants removed from patients and returned to the manufacturer must be analyzed in an effort to determine what went wrong.

"It is important to remember that breast implants are not lifetime devices … they should recognize that long-term monitoring is essential," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

- read the FDA announcement
- here's the company's release

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