|Allergan won FDA approval for Natrelle 410--courtesy of Allergan|
Allergan ($AGN) picked up FDA approval for Natrelle 410, a breast implant designed to mimic human anatomy, and the agency has cleared the device for reconstruction and augmentation surgeries.
Natrelle 410 is already on the market overseas, where Allergan says it's the most popular implant choice. The product is filled with a novel highly cohesive silicone gel, helping it hold its shape over time while remaining soft to the touch.
The FDA looked at a study of 941 women outfitted with Natrelle 410, deeming the implant safe and effective but requiring Allergan to conduct a series of postmarket studies, following patients for 10 years and reporting back rates of revision procedures, rare disease development and other adverse events.
For Allergan, getting its most popular implant approved in the U.S. could mean a big boost in medical device sales as it prepares to unload its obesity unit this year. Earlier this month, the company announced that it is all in on selling off the business that makes the once-popular Lap-Band, but it's unlikely to fetch a large closing price, as the unit's revenue plummeted 21.5% to $159.5 million last year. Lap-Band has faced lawsuits, safety concerns and failed bids for expanded indications since its 2009 heyday, and the Orbera intragastric balloon system hasn't sold well enough to balance that out.
Allergan has already started reporting its obesity revenues as a discontinued operation, but the company is projecting a strong 2013 even without Lap-Band. In addition to the planned rollout of Natrelle 410, Allergan expects big sales for eye drugs Alphagan and Restasis, plus another giant year for Botox, which the company projects to bring in up to $2 billion on its own.
- read Allergan's statement
- check out the FDA's announcement