FDA Approves Natrelle 410 Silicone Breast Implants from Allergan
410 Implant Offers Natural Shape and Cohesive Silicone Gel
Recent Food and Drug Administration (FDA) approval of the Natrelle 410 breast implant offers yet another option for women undergoing breast augmentation or breast reconstruction. Unlike the “round” look usually found in implants, the anatomically shaped silhouette closely mirrors the natural curves of a woman’s breast while remaining soft to the touch.
Previously only available in Europe and Canada, it was the most selected gel implant in markets there. And because the implant contains a highly cohesive gel, it is designed to hold its shape for a long period of time. The latter is especially good news for patients who have “minimal breast tissue remaining after the removal of a tumor or have lost breast volume over the years,” adds Scott L. Spear, M.D., FACS, chairman, Department of Plastic Surgery, Georgetown University School of Medicine.
Approval was based on several years of data with nearly 1,000 women. Most complications were similar to those found in previous breast implant studies — tightening of the area around the implant (capsular contracture), re-operation, implant removal, rupture and infection. In addition, some implants had cracks in the gel.
Overall, however, the FDA has deemed it to be safe and effective. And, as a condition of continued approval, Allergan must conduct additional studies of 3500 women receiving the Natrelle 410 over the next five years as well as studies of potential long-term complications and occurrence of certain diseases, as well as evaluating women’s perceptions of patient labeling and analyzing manufacturer returns.
Adds Dr. Spear: “The option of a breast implant designed with an anatomical shape that lasts over time is important as it may help [women] obtain the aesthetic look they are seeking.”