FDA Gives Green Light to SoftTouch Breast Implants, Creating New Option for Patients

The U.S. Food and Drug Administration (FDA) approved NATRELLE INSPIRA ^® SoftTouch breast implants for women who are undergoing breast reconstruction, augmentation or revision surgery.

The breast implants have a medium firmness gel, or cohesive, implant option, according to Allergan plc, the producer of the implants.

"Adding NATRELLE INSPIRA^® SoftTouch breast implants to our already robust line of offerings gives Allergan the most extensive variety of implants in the industry and provides doctors with a wide range of options," David Nicholson, Chief R&D Officer of Allergan plc, said in a press release. "Now, the INSPIRA^® line of breast implants help physicians to better meet diverse, patient-specific needs based on available breast tissue and desired outcomes.We're delighted to have this offering available in the U.S. since they are so popular with doctors and patients internationally."

The approval of NATRELLE INSPIRA^® SoftTouch breast implants is adding to the family of products in the US NATRELLE line, which offers implants ranging in firmness and form stability.

Silicone-filled implants are approved for women who are at least 22 years old and have undergone breast augmentation, and saline-filled implants are approved for patients who are at least 18 years old who had breast augmentation.

Women who have active infection anywhere in their body, existing breast cancer or precancer, who did not yet receive adequate treatment or women who are pregnant or nursing, should not get breast implants

Some complications that may arise with the implants include: reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants and severe scar tissue that may form around the implants.

“This is one of the most exciting times in the history of breast surgery and what a great time for women, who are looking to have augmentation or have to have reconstruction," said Allen Gabriel, M.D., F.A.C.S., of PeaceHealth Plastic Surgery, in a statement. "My patients now have so many options available to them thanks to companies like Allergan who are supporting ongoing research and innovation in this area."