FDA Approves Allergan’s New Gel-Filled Breast Implant

California-based company Allergan has received the green signal from the U.S. Food and Drug Administration for its new silicone gel-filled breast implant. 

The product that received the FDA's nod is Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Gel Filled Breast Implant. According to the FDA press release, it has been specified that it can be used by women only above 22 years of age.

FDA's decision was based on seven years of data from 941 women. The complications and outcomes observed were similar to those found in previous breast implants, such as tightening of the area around the implant and infection. Apart from that, fissures were observed in the gel of some Natrelle 410 implants.

"It's important to remember that breast implants are not lifetime devices. 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," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a press statement.

He continues to say that the data displayed a reasonable assurance of two prime factors: safety and effectiveness.

The new products consist of several cross linking when compared to the silicone gels used in Allergan's previously sanctioned Natrelle implant. These cross links make the gel firmer.

The company had to abide by certain conditions that follow the approval. It includes a monitoring of the 3,500 women who have received the Natrelle 410 implants for five years as part of the company's continued access study, and analyzing the Natrelle 410 implants that are removed from patients and returned to the manufacturer.

Till date, there are four FDA-approved silicone gel-filled breast implant products available in the U.S.