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Breast Implants in the News: Are They Still Safe?

With the news coverage from Europe, and after the recent FDA meeting, we've received renewed interest, concern and confusion regarding "Breast Implant Illness" (BII) and Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). These are two distinct conditions. The majority of new information and scientific evidence is regarding BIA-ALCL, not Breast Implant Illness (BII). Please read more about BIA-ALCL here.

The FDA announced May 2, 2019, all breast implant options remain safe and effective and will continue to be available in the U.S.

The short answer is yes. Implants are, and always have been, safe. However, there are no surgical procedures, or medications, that have zero risk or side effects, breast augmentation included. While the majority of woman do well after surgery, and 98% of woman reviewing the procedure on RealSelf say it was “worth it,” a few percent (5% in Dr. Feldman’s practice) of woman have local cosmetic complications, and an even smaller number attribute future health issues arising after augmentation, to their breast implants. In medicine anything is possible, as each patient’s genetics, and environmental exposures, are unique. Therefore, it would be foolish to automatically eliminate breast implants as a possible contributing factor to any patient’s symptoms, particularly since removal is a low-risk, straightforward, operation that can eliminate breast implants as a causative variable. Removal is rare, however. Dr. Feldman has placed over 3,000 sets of implants, and has only removed 3 sets.

The FDA continues to disagree with reports that breast implants elevate risk of developing systemic medical conditions such as breast cancer, autoimmune disease, arthritis, lupus, fibromyalgia, fatigue, Lyme disease, pain or general lack of well-being. These conditions are collectively referred to as “Breast Implant Illness” (BII). The one exception is the EXTREMELY rare BIA-ALCL, which appears to be strongly related to a textured implant shell, however the FDA does NOT recommend prophylactic removal in asymptomatic patients even with textured shells as it is so rare. 99.97% of the implants placed by Dr. Feldman have smooth shells. There are ongoing medical studies to ensure the highest level of patient safety.

"A few of our international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants, based on concerns about BIA-ALCL. In those markets, there are textured implants that are not marketed in the U.S. and where the use of textured implants is much higher, sometimes as high as 80% market share. In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S. The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here. At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act. The FDA believes regulatory action must be based on scientific data."

Of course, there are unverified internet stories about both silicone and saline implants causing health problems, but they have never been proven or reproduced in large controlled medical studies, making it difficult to ascertain their validity. There are many causes of the above-mentioned conditions and developing the symptoms chronologically after implant placement, unfortunately, does not indicate causation. Implant removal will certainly provide anxiety relief and “peace of mind” but unfortunately there is no scientific data to suggest it will improve symptoms beyond that.

Dr. Feldman encourages concerned patients’ see their PCP for evaluation and workup of other, more common, causes of similar symptoms. These include but are not limited to: depression, anxiety, hypothyroid, autoimmune disorders, rheumatoid arthritis, lupus, West Nile virus, Zika virus, Lyme disease, multiple sclerosis, anemia among others. Within a few weeks of surgery, it’s also possible the physiologic stress of surgery itself could cause the symptoms, or triggered a flare up of a preexisting underlying, but previously undiagnosed or unnoticed medical condition.

There are three options for patient’s concerned about BII: removal without replacement, removal and replacement with a different type of device or awaiting results of further workup from PCP. Should discomfort and constitutional symptoms be severe enough to impact daily home or work activity, Dr. Feldman would recommend, and support, implant removal concurrent with additional workup. Unfortunately, implant removal is not a cosmetic procedure, and no guarantee can be made as to what the aesthetic appearance will be after removal, because the priority is on improving health and wellness, not aesthetics.

Please do not hesitate to reach out to our office should you have questions or concerns about your health as it relates to Breast Implant Illness (BII).