FDA Approves New Silicone Breast Implant
There is a new breast implant choice with the FDA’s approval of Sientra Inc.’s silicone gel breast implant.
Sientra’s implants have been approved for breast augmentation in women 22 years and older and for breast reconstruction in women of any age.
With the latest approval, there are now three silicone gel-filled breast implants approved by the FDA in the U.S. They are manufactured by Allergan, Mentor and Sientra.
“Sientra has successfully broken the existing duopoly in the U.S. by offering surgeons and patients a new choice,” said founder and CEO Hani Zeini, in a statement.
Zeini also said that the company will offer shaped implants in addition to standard round implants.
The approval was based on a three-year clinical trial of 1,788 participants. The trial had similar complications and outcomes found in studies of other breast implants.
“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, MD, deputy director for science in the FDA’s Center for Devices and Radiological Health.
Maisel stressed that women should be aware that breast implants are not lifetime devices and recognize that long-term monitoring is essential.
Post-approval, Sientra will continue to monitor the clinical trial participants for seven years. In addition, they will have a 10-year study of 4,782 women who receive Sientra silicone implants to collect data on long-term complications and outcomes. Finally, Sientra must also conduct case studies to evaluate the association between their implants and five rare diseases, including brain cancer, cervical/vulvar cancer and lymphoma.