Implant maker Sientra Inc. must conduct safety studies, FDA says
A new silicone filled breast implant made by Santa Barbara-based Sientra Inc. is the third such implant to be approved by the U.S. Food and Drug Administration.
The approval, which was awarded on March 9, was conditioned with required studies to prove the implants’ safety and effectiveness, as well as risk of disease. The FDA used three years worth of data gathered from studying the effects of the implant on more than 1,700 participants.
“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health, said in the press announcement. “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”
The studies showed outcomes and complications similar to the other approved breast implants. They include: scar tissue/muscle tightening around the implant, known as capsular contracture; re-operation; implant removal; asymmetrical results in appearance; and infection.
The manufacturers of the other two approved silicone-filled implants are Mentor Inc., also based in Santa Barbara; and Allergan Inc., based in Irvine. For more information on breast implants regulations, visit FDA.gov/breastimplants.
Breast implants are used in a surgical procedure to enlarge or reconstruct women’s breasts. Implants are placed either under existing breast tissue or under the chest muscle. The come in different cup sizes and shapes; some are more textured while others are smooth.
Breast prosthetic implants are currently available in the U.S. either filled with a saline solution or silicone gel. The procedure for implanting the prosthetic can cost anywhere between $4,000 to $8,000. Most insurance companies will not provide coverage for breast implants.
The U.S. National Institutes of health continually seek women with breast implants who may be interested in participating in a medical trial. For more information about such clinical trials, visit ClinicalTrials.gov.