Allergan wins FDA nod for Natrelle Inspira breast implants

Allergan (NYSE: AGN) said last week that it won FDA pre-market approval for its Natrelle Inspira cohesive breast implants for women undergoing breast reconstruction, augmentation or revision surgery.

The newly cleared Natrelle Inspira implants combine both a high gel fill ratio and the company’s cohesive gel to create a customized shape, the company said.

“Natrelle Inspira cohesive breast implants are just the latest example of our commitment to innovation in breast aesthetics and plastic surgery, and we are proud that we are able to continue to offer advancements in technology that allow physicians and their patients more options. Natrelle Inspira cohesive allows patients to get the same high gel fill ratio and fullness offered by the Natrelle Inspira line of implants, with our highly cohesive, form-stable gel,” chief R&D officer David Nicholson said in a press release.

“I make it my personal mission to give my patients the best possible cosmetic results after breast reconstruction. I’ve been waiting for a form stable, cohesive round implant. I’ve been waiting for Natrelle Inspira Cohesive,” Dr. Lisa Cassileth of Cassileth Plastic Surgery said in a prepared statement.

In Nov. 2014, Allergan said the FDA approved 2 new styles of its Natrelle 410 silicone-filled breast implants, the Natrelle X and L. The implants were approved for use in women undergoing breast augmentation, reconstruction or revision surgery.

The Natrelle 410 1st won FDA approval in February 2013, but the federal watchdog agency stipulated that Allergan run a post-approval study to keep an eye on its long-term safety and effectiveness.

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