By Mark W. Clemens, MD FACS
Breast Implant Illness (BII) is a recently described constellation of symptoms some women have described after receiving a breast implant either for cosmetic augmentation or breast cancer reconstruction.
The US Food and Drug Administration (FDA) notes in public statements and on their website that they have received reports of some women who experienced symptoms with both saline and silicone gel-filled breast implants. These symptoms are termed “systemic” meaning occurring throughout the body and outside of the breast area. The FDA further explains that symptoms are very diverse between patients and may include fatigue, memory loss, rash, “brain fog,” and joint pain.
Patients and some caregivers have used the term “breast implant illness” (BII) to describe some or all of these symptoms. These symptoms may sometimes develop after only a few months or many years after receiving the implants.
Currently, these symptoms and what causes them are poorly understood and there are no known blood tests or imaging studies to test for or confirm BII. Even when women display these symptoms, blood tests are frequently normal and do not demonstrate any infection or inflammation.
There are no known factors that have been identified that increase risk of developing these symptoms. BII symptoms appear to only affect a small minority of patients receiving breast implants. The FDA notes that in some cases, removal of the breast implants without replacement has been reported to reverse symptoms of breast implant illness. Importantly, the FDA has not detected any association between breast implants and breast cancer or reproductive problems. Currently, researchers are investigating these symptoms to better characterize BII, understand the origins, and relation to breast implants.
For any patients that may experience these symptoms or for any injury with a medical device, the FDA encourages reporting by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
About the author:
Dr Mark Clemens is a board certified plastic and reconstructive surgeon at the MD Anderson Cancer Center, and contributor to the Breast Advocate® App. Dr Clemens’ research interests include outcomes and translational research involving microvascular and prosthetic reconstructive surgery of the breast. He is also a leading authority on breast implant-associated anaplastic large cell lymphoma (bia-ALCL) and co-leads a multidisciplinary clinical and laboratory research team on the investigation of bia-ALCL.