On July 24, 2019, Allergan voluntarily recalled unused BIOCELL® textured breast implant products.
Each breast implant maker uses a different technique for creating the texture on the implant. The different techniques behave differently, and are not comparable.
The recall is only for the Allergan type of texturing implants that have not been used in patients, and not for Sientra or Mentor textured breast implants. Sientra and Mentor implants use a micro-texturing process, different than the macro-texturing of Allergan.
At this time, the Food and Drug Administration and plastic surgery professional organizations do not recommend the removal of these implants in patients who are showing no signs of breast implant associated anaplastic large cell lymphoma, or BIA-ALCL, a rare cancer of the lymphatic system. But it is wise to be on the lookout for any significant swelling or lump in the breast, especially if that shows up many years after the implant surgery. Ultrasound and MRI are excellent ways to screen for implant-related issues. Onset of BIA-ALCL is typically not subtle, and involves sudden or rapid enlargement of the breast due to fluid, and/or a mass or lump. This very rare lymphoma is part of the implant capsule, scar tissue that forms around all implants, and is almost always cured when the capsule is fully removed. At this time, fewer than 600 cases have been identified worldwide. Allergan is offering the smooth device implant replacement at no charge to the patients, however, additional costs (i.e., surgical fees) are not covered.
Mauricio J. Castellon, MD, FACS, Melbourne based board-certified Plastic Surgeon, and founder of the Castellon Plastic Surgery Center, has been appointed president of the Florida Society of Plastic Surgeons (FSPS).
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