FDA Recommends Its Most Serious Warning Label for Breast Implants
The Food and Drug Administration last week issued a “final guidance” regarding the health risk of breast implants, concluding that implant manufacturers should include a black box warning. The warning is the agency's most stringent, named for the black box that frames the language calling attention to "serious or life threatening risks."
The FDA also suggested manufacturers incorporate “a patient decision checklist into the labeling for breast implants to better ensure certain information is received and understood by patients.”
“That's the strongest warning by the FDA that a product carries the risk of serious injury or death,” Dr. Marisa Lawrence, an Atlanta-based plastic surgeon, told Georgia Public Broadcasting.
The updated guidance is a response to findings on the health risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) — a rare but potentially deadly cancer.
There is also the risk of patients developing “breast implant illness,” which can cause fatigue, brain fog, muscle or joint pain and rash, according to the FDA.
Last month, a study published in the Annals of Plastic Surgery found that removing breast implants relieved those symptoms, and others, for patients who had previously gotten breast implant surgery and developed breast implant illness.
The study identified 11 key symptoms — numbness and tingling in the extremities, hair loss, memory loss/cognitive problems, dry eyes and/or blurred vision, breast pain, food sensitivity/intolerance, flu-like symptoms and/or low-grade fever and difficulty breathing, in addition to those noted by the FDA (fatigue, muscle pain, rash).
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Once their implants were removed, the patients in the study noted “significant immediate and sustained improvement” in their symptoms.
Several high profile celebrities have opened up about experiencing breast implant illness and then subsequently removing their implants. Most recently, Ashley Tisdale revealed on Instagram that she opted for implant removal surgery after experiencing “minor health issues” that she believes may have been caused by her implants.
“Little by little I began struggling with minor health issues that just were not adding up — food sensitivities as well as gut issues … that I thought could be caused by my implants. So, last winter I decided to undergo implant removal,” she said in an August post.
“This journey has been one of growth, self discovery, self acceptance and most importantly self-love,” Tisdale, 35, added. “This picture above was taken two months after my explant surgery and I think you can tell just how happy I am to finally be fully me.”