Three years ago, the FDA banned the use ofcertain silicone breast implants. Now they have issued another warning that textured silicone implants are associated with lymphoma and should be monitored. The director of the Department of Plastic and Reconstructive Surgery at Rambam Health Care Campus (Rambam) in Haifa, Israel, weighs in.
Professor Assaf Zeltzer. Credit: Rambam HCC.
Some textured silicone breast implants for breast augmentation and reconstruction with high average surface roughness are associated with a rare lymphoma, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Silicone debris may cause chronic inflammation, leading to BIA-ALCL and related morbidity. In a recent consensus statement regarding this risk, the American Society of Plastic Surgeons reported that of 1344 BIA-ALCL cases known of worldwide in January 2023, 59 had died. Hence, based on the newly published data, the FDA issued a new recommendation that textured implants be closely monitored. Since the incidence of this type of cancer is relatively uncommon, and removing the implant carries its own risks, the FDA reminded patients to consult with their healthcare provider regarding their ongoing care.
Professor Assaf Zeltzer, Rambam’s director of the Department of Plastic and Reconstructive Surgery, elaborates, “Twenty years ago, the first cases of BIA-ALCL were noted, and the FDA recommended the removal and replacement of Poly Implant Prothèse (PIP-type) implants, among others. The FDA’s latest announcement does not unequivocally recommend removal of the implants.” He points out that it is a reasonable step, “especially if a woman has symptoms or suspicions indicating a possible problem, but there is no need to panic.”
“In most cases, the problem appeared years later. There are only a few BIA-ALCL cases in Israel, but it is important to be aware of the problem. The classic symptom is swelling of the breast caused by an accumulation of fluid some ten years after implantation. Plastic surgeons are aware of the problem and carefully follow their patients. If someone presents with these symptoms, physicians must rule out lymphoma.”
It should be noted that the lymphoma caused by a textured implant is not the same as breast cancer. If diagnosed early on simple removal of the implant, surrounding fluid, and scar tissue should be enough. Unlike breast cancer, radiation and chemotherapy are not required.
“Bottom line, there is no need to panic, just be aware,” concludes Professor Zeltzer. “In their recent announcement, the FDA expressly referred to textured implants, and we have not used them in Israel for several years. Israel’s Association of Aesthetic Plastic Surgeons supports the FDA’s recent announcement. Israel’s plastic surgeons are professional, explain the problem to their patients, and a yearly examination is recommended.”
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