The FDA has approved a breast implant offered by Allergen plc for women undergoing reconstructive or revision surgery.
The Natrelle Inspira SoftTouch, which can also be used for breast augmentation, is a new option offering a medium firmness cohesive implant, according to an Allergan release.
Natrelle is the only breast implant line with three levels of cohesive gel, the release added.
The FDA approved Natrelle for breast augmentation with silicone-filled implants in women aged 22 years or older. It has also granted approval to the implant line for augmentation with saline-filled implants in woman age 18 and older.
Complications associated with breast implants include repeat operations, implant removal or replacement, rupturing of silicone-filled implants, deflation of saline-filled implants and severe scarring.