Recently, the FDA released augmented safety requirements for breast implants as the result of updated study findings. Implants now must come with a black box warning and companies must disclose the specific materials used in implants and may only sell implants to healthcare providers who cover the potential risks associated with breast implants. In addition, the FDA is providing new guidelines on screening recommendations for silicone implant rupture and a patient decision check list. You can read the full press release from the FDA click here.
These new requirements and guidelines are a result of the increasing awareness and interest in immune responses to implants. Some women who have had breast augmentation have reported experiencing auto immune symptoms such as: joint and muscle pain, fatigue, anxiety, depression, hair loss, digestion difficulty, and skin reactions. This range of inflammatory symptoms has been referred to as Breast Implant Illness (BII), but BII is not officially recognized as a diagnosis. Often times removal of the implants will completely resolve the symptoms, but not always. BII is not well understood and not well studied as the symptoms are often variable between patients and often symptoms of other autoimmune or inflammatory diseases. Further study of women experiencing these symptoms is necessary to better understand the mechanism behind BII and possible future therapies that would allow women to keep the implants. Furthermore, with the characterization of BIA-ALCL, a specific type of lymphoma associated with textured implants, there is a greater suspicion of the effects that implants can have on the body. The first case of BIA-ALCL was recorded in 1997 in a medical journal, but the link between implants and this specific cancer was not established until 2011. It was not until 2016 that BIA-ALCL gained more traction worldwide after being designated as a unique lymphoma. Further information regarding BIA-ALCL can be found at breastcancer.org.
Encouraging and providing the resources for women to educate themselves prior to choosing implants is essential especially considering the serious repercussions implants can have on women’s overall health. While the new guidelines surrounding labeling of implants will not impact the body’s response to implants, they will ensure that patients are well informed and better equipped to decide if breast implants are the right choice for them. If you are considering implants, consult with a board certified plastic surgeon to ensure you are getting the most accurate and up to date information.
If you’re considering breast implants, contact our clinic at 312-695-6022 or through the request form in the header to schedule a consultation with board-certified plastic surgeon Dr. John Kim. He can help you decide if breast implants are right for you.