The FDA hearings on breast implants in March 2019 prompted a large number of phone calls to our office. The patients had two main questions about breast implants…BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma) and BII (Breast Implant Illness).
We have addressed the BIA-ALCL issues in previous blogs on this website. Briefly stated, BIA-ALCL is a secondary cancer (lymphoma) of the breast strongly associated with textured implants especially the Allergan 410 or “gummy bear” implants. A number of plastic surgeons in St. Louis heavily promoted and placed many of these implants in patients. One of the key witnesses at the FDA hearings is from the St Louis area. She had Allergan 410 implants placed for breast reconstruction after mastectomies only to develop BIA-ALCL about two years after. I have never used these 410 implants and have a preference for Mentor smooth wall implants.
Breast Implant Illness (BII) is reminiscent of the silicone breast implant controversy and subsequent moratorium of the 1990’s that I had to deal with as a young new plastic surgeon. BII is a self-identifying problem that patients’ attribute to their implants. These complaints may include fatigue, chronic pain, depression, neurologic issues, headaches, joint pain, hair loss, etc. There is no test available to determine BII and therein lies the problem. There is no existing way to prove or disprove causation or association. In 1999, the Institute of Medicine Committee on the Safety of Silicone conducted an extensive review of scientific literature and concluded there was no demonstrated clear link between silicone implants and any systemic illness. Implants were released for general use again in 2006 with few restrictions.
But all the concerns came back after an article in January 2019 looked back at 100,000 breast implant patients. Unfortunately the data collection had many limitations and the “conclusions” drawn should have only been “associations.” The limitations on data collection included mixed populations (silicone and saline implants, augmentation and breast reconstruction patients), a high attrition rate (~ 70% of patients did not have follow-up visits or reports), and a mixed basis for disease diagnosis (self-reporting vs physician determination). This recent data was also in disagreement with many recently published peer reviewed studies.
The important take home points are what I counsel to all my patients during our pre-operative consultation:
- Implants are not a lifetime one and done. Sometime in the future you will have to have another surgery which could be in 6 months or 50 years from the time of initial implant placement.
- Implants do obscure some of the breast tissue on mammograms.
- Implant patients do not have more advanced or more aggressive breast tumors and the implants do not interfere with appropriate treatment of the breast cancer.
- Textured implants have been associated with breast lymphoma but I do not use textured implants.
- Scientific studies have failed to demonstrate a clear link between silicone implants and any disease or illness. But some patients have severe enough symptoms that the implants are removed.