Last week the FDA convened a meeting of the General and Plastic Surgery Devices Panel at the FDA’s Headquarters, to discuss the benefit-risk profile of breast implants.
The main areas of question and concern raised by the public and health care providers is “breast implant related illness” which is a range of autoimmune-related symptoms, and breast implant associated anaplastic large cell lymphoma (BIA-ALCL), which is a very rare reaction correlated with some textured implants.
After two days of thorough discussion with representation from top researchers, plastic surgeons, and the public, the FDA did conclude that:
Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size or to rebuild (reconstruct) breast tissue after mastectomy or other surgeries the breast.
There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. Implants vary in size (volume), shell thickness, shell surface texture (smooth or textured), and shape (round or tear-drop).
Since the moratorium of silicone implants in the 1990s, improved cohesivity (stickiness) of silicone gel, has improved the safety profile and returned silicone implants as the gold standard of both cosmetic and reconstructive breast augmentation options. Implants are no longer the liquid silicone as in the past, but “gummy”. For example, if you were to cut an implant in ½, it would stay as two solid pieces. There is minimal to no risk that a ruptured implant would spread outside of the breast capsule (the scar tissue surrounding the implant).
The best way to prepare for your implant surgery is to have an open conversation and ongoing communication with your plastic surgeon.
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