Irvine-based pharmaceutical firm Allergan announced Wednesday it has received federal regulatory approval for its latest silicone-filled breast implant, making it available for purchase in the United States.
The product, called Natrelle 410, is for women 22 or older who planning to undergo breast reconstruction or breast augmentation surgery. Allergan said the new implant differs from its competitors because it copies the slope of a breast and holds its shape over a longer period of time, while remaining soft to touch.
Prior to Natrelle 410's approval, Allergan had sold round silicone gel implants and round saline implants in the U.S., said spokeswoman Cathy Taylor. Natrelle 410 has already been sold in Europe and Canada.
The U.S. Food and Drug Administration said its approval factored in seven years of data involving more than 900 patients. The FDA said investigators had seen cracks in the gel of some Natrelle 410 implants, but deemed it safe to sell in the U.S. market.
“It’s important to remember that breast implants are not lifetime devices," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health in a press release. "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."
The FDA gave its approval based on Allergan following through on certain conditions, including the completion of certain studies and another 10-year study involving more than 2,000 patients.
Allergan's spokeswoman Cathy Taylor didn't comment on how much Natrelle 410 would cost patients, saying the company does not give recommendations on the prices surgeons charge patients for any surgical procedure.
"Patients should discuss surgical cost with their individual physicians," Taylor said in an e-mail. "Implantation of shaped devices is a more complex procedure, so some physicians may charge more than they do implant round devices."
Breast aesthetics products represent $91.4 million in sales or about 6 percent of Allergan’s overall revenues. The company made about $1.5 billion in net sales and $324.2 million in net income its fourth quarter.