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Breast Implant Update/BIOCELL® Implant Recall

Despite the closure of my office, I am still committed to the health and well-being of my patients.  Furthermore, my motto has always been,  “An educated patient is a happy patient”, and I have routinely kept my breast implant patients, cosmetic or reconstructive, informed of current information regarding breast implant safety.

As you have likely heard the past week, Allergan, a major manufacturer of breast implants, has voluntarily recalled BIOCELL® Textured Breast Implants and Tissue Expanders across their worldwide markets. Their global action follows a specific request from the U.S. Food and Drug Administration (FDA) for Allergan to voluntarily recall certain breast implants and tissue expanders from the market due to the risk of Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL) (see previous updates on my website Blogs about this topic).  An explanation of this action can be found in layman’s terms in a New Beauty publication found here:

https://www.newbeauty.com/blog/dailybeauty/12832-allergan-recall-biocell-textured-breast-implants-explained/

For my breast implant patients, be aware that the majority (>90%) of all the implants I placed since starting my practice in 1987 were from the manufacturer Mentor, formerly Heyer Schulte. Some of these were Siltex textured implants; Siltex is a micro textured surface, not associated with BIA-ALCL. On occasion, typically for breast reconstruction, I have used Allergan (formerly McGhan and Cox-Uphoff) BIOCELL® macro textured implants. That was many years ago; note the average time frame for developing BIA-ALCL is 8 years, and I can assure my patients that I have not placed any Biocell implants in at least 10 or more years. The recall only applies to BIOCELL®  macro textured implants.

Importantly, for existing patients with BIOCELL® implants, the FDA statement re-emphasizes that they do not recommend the removal or replacement of textured breast implants in asymptomatic patients.The FDA’s recommendations, along with updated data on BIA-ALCL can be seen here:

https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

Allergan has also created the BIOCELL® Replacement Warranty for all patients currently implanted with BIOCELL® textured implants. The details of this effort can be found here:

https://www.surgery.org/sites/default/files/downloads/blasts/BIOCELL/BIOCELL2.pdf

My two specialty societies’ (ASPS and ASAPS)  latest information about BIA-ALCL  can be found here:

https://www.surgery.org/sites/default/files/BIA-ALCL-Talking-Points-6-24-19.pdf