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:
- There is a lack of scientific certainty about risk implants pose, and
- A call to further research is needed
ABOUT BREAST IMPLANTS
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.
When considering breast implant surgery please know that:
- Breast implants are not considered lifetime devices. Over time the chance of complications, most commonly rupture, increases. Understand that after breast implant surgery, most, if not all patients will require or request additional breast implant related surgery in their lifetime, whether to remove, replace, or lift the breast as it changes over time.
- Communicate with your surgeon. Surgery is not a “one and done” phenomenon. Surgery is a lifetime relationship with your provider.
- Keep and maintain records of your implants. Every patient receives cards with unique serial number describing the exact specifications of the implants. This will help you and your providers plan the most appropriate revisions if necessary.
- Know that monitoring is important. With saline implants, imaging is not necessary outside of routine breast cancer surveillance such as mammograms. However for silicone guidelines recommend a bilateral breast MRI every 3 years after implant to evaluate integrity of implants (rule out rupture).