Breast Implant Tracking: New FDA Rule
- Posted on: Oct 7 2013
All breast implants are considered medical devices, and currently breast implant manufacturers for the US market include Allergan, Mentor and Sientra. Whether used for cosmetic purposes such as in breast augmentation or enhancement, or in breast reconstruction, all breast implants carry identifying serial numbers so patients can be monitored in case of post-surgical issues. In addition to the system already in place, the FDA has recently passed a rule whereby a new electronic system will begin tracking all medical devices. This new system was designed to protect patients by catching problematic implants – including pacemakers and hip replacements – earlier. Medical devices sold in the U.S. will now be required to carry a unique code, identifying its make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.
Breast implants are available in a variety of options besides size and volume, including saline or silicone gel (regular silicone gel and highly cohesive silicone gel) fill, smooth or textured shell, round or tear drop shape, and low, medium or high projection. As medical devices, all carry potential risks of complications once inserted in breast plastic surgery, such as rupture. The latest measure by the FDA is meant as an additional measure to protect patients in case any problems arise.
Dr. Hutchinson is a board certified plastic surgeon in NYC with a practice dedicated to aesthetic plastic surgery of the breast, face and body. Our office on Manhattan’s Upper East Side offers a fully AAAASF certified Operating Room for the safety, privacy and convenience of her patients. To schedule a consultation with Dr. Hutchinson, please contact us or call us at (212) 452-1400.
Posted in: Medical News