The Food and Drugs Association announced Wednesday that it has approved a new silicone-gel breast implant developed by California based Allergan.
The U.S. health regulator FDA announced Wednesday that it has approved Allergan Inc's new silicone-gel Natrelle 410 implants, designed to increase the size of a woman's breast. The implants can only be used by women above the age of 22.
According to the California based pharmaceutical company, the new implant is firmer than its previous Natrelle implant. The company also noted that their new implant is better than many other in the market as it copies the shape of the breast and holds its shape for a longer period of time. The new implant is also firmer but keeps the breast soft to touch.
Prior to the new implant, Allergan already had a round silicone implant and round saline implants in the markets. The new Natrelle 410 implants are already available in Canada and Europe.
The FDA announced that its approval came after seven years of studying the product and has looked into several factors of the product. While the health regulatory body observed a few cracks in the implant, it said the implant was safe to sell in the U.S. markets.
"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 also mentioned that its approval is based on some conditions that include studying the product for the next ten years.
Allergan didn't comment on the price of the implant saying patients should discuss this topic with their physicians.
"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."
