|Allergan's Natrelle 410--Courtesy of Allergan|
Allergan ($AGN) scored early in 2013 with a long-awaited FDA approval for Natrelle 410, a breast implant designed to mimic human anatomy. The product, approved for reconstruction and augmentation surgeries, has been available overseas for some time. It is unique due to a novel kind of highly cohesive silicone gel that holds its shape over time without becoming too firm.
The FDA's approval means the U.S. market now has four approved silicone breast implant products made by three companies: Allergan, Mentor and Sientra, a relatively small number reflecting continued regulatory caution over implants of this type. For Natrelle 410, it took 7 years of data from 941 women for Irvine, CA-based Allergan to earn the FDA's blessing. The FDA's signoff also came with a number of costly conditions, including the requirement that Allergan conduct a 10-year postmarketing study of more than 2,000 women who received the implant postapproval to explore long-term complications and possible disease risks.
Allergan expects breast implants, or "breast aesthetics," to generate between $380 million and $390 million in net sales for 2013, out of an estimated $6.1 billion to $6.2 billion in overall product sales. That's a decent slice of Allergan's pharmaceutical and device product roster that will become increasingly important in the months ahead, now that it has sold off its obesity intervention business to Apollo Endosurgery for $110 million.
Allergan wins FDA approval for novel breast implant
Apollo Endosurgery raises $90M to help pay for Allergan's obesity intervention business