Allergan, a healthcare products manufacturer based in Irvine, California, announced that it received approval from the United States Food and Drug Administration for its Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants. However, the regulatory approval comes with some caveats. According to a press release by the company, the FDA will require the company to conduct post-approval studies to determine long-term efficacy and safety for the device.
In its press release, the company detailed the patient benefits of the Natrelle 410. Compared to traditional round gel implants, the Natrelle 410 features a highly-accurate anatomical shape that imitates that natural slope found in the breast. In addition, the implant is filled with a specialized silicone gel that will hold its shape for a very long time while remaining soft and malleable.
David Pyott is the CEO and president of Allergan. In prepared remarks, he said, "The Natrelle 410 is the most-selected shaped gel implant in markets where the product is already available, such as Europe and Canada." He continued, "We are pleased that the FDA has recognized the benefits and safety of the Natrelle 410, and has now made the product available as an additional option for women in the United States."
As of now, there are four silicone breast implants available in the U.S. with FDA approval. Allergan’s implant joins implants from industry giants like Sientra, Mentor and Johnson & Johnson.
While the Natrelle 410 breast implant does have some benefits over its competitors, it is subject to the same issues that plague other brands. This includes tightening around the site of implantation and the need for revision surgeries. In addition, breast implants are prone to infection and implant asymmetry.
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