Allergan announces worldwide withdrawal of Biocell textured implants
Allergan announced this morning that it is withdrawing its Biocell textured breast implants and tissue expanders.
The move follows increased scrutiny on textured breast implants and their connection to BIA-ALCL, an uncommon lymphoma that can develop around breast implants. The U.S. Food and Drug Administration (FDA) requested that Allergan withdraw specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL, and Allergan agreed to voluntarily issue the withdrawal as a precautionary measure.
Biocell saline-filled and silicone-filled textured implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. The company urged healthcare providers to cease implanting its Biocell products and return any unused devices to Allergan.
The withdrawal does not affect the company's Natrelle smooth or Microcell breast implants or expanders.
"As plastic surgeons, patient safety is always our top priority," says ASPS President Alan Matarasso, MD. "The Society will continue to study BIA-ALCL through the PROFILE registry and provide updated information and resources to physicians and the public. This development underscores the need for all plastic surgeons to enter all breast implant cases into the National Breast Implant Registry (NBIR) and all BIA-ALCL cases into the PROFILE registry."
The FDA notes that women who have these implants but no symptoms, do not need to have them removed. Common symptoms include breast enlargement, pain, asymmetry, lump in the breast or armpit, overlying skin rash, hardening of the breast or a large fluid collection typically developing after receiving an implant and, on average, after 8 to 10 years.
ASPS provides a wealth of information on breast-implant safety and BIA-ALCL, including facts, statistics, informed-consent language, insurance coverage information and a list of frequently asked questions for both doctors and patients at plasticsurgery.org/alcl.
The PROFILE registry contains a total of approximately 288 cases of BIA-ALCL in the US and 735 worldwide since the initial case report in 1996. The PROFILE registry contains cases which are voluntarily reported and may not accurately reflect the actual number of cases.
"Through the National Breast Implant Registry (NBIR), a collaboration between The Plastic Surgery Foundation (The PSF), ASPS and the FDA, plastic surgeons are gathering data to improve safety of the device," says The PSF President Andrea Pusic, MD, MHS. "It is very important for all plastic surgeons to enter all implant-based cosmetic and reconstructive breast surgery cases into NBIR and any BIA-ALCL cases into PROFILE."
ASPS members are encouraged to participate in the National Breast Implant Registry and can register at thepsf.org/nbir. Additionally, the FDA recommends that any suspected or confirmed cases of BIA-ALCL be reported to the PROFILE registry at thepsf.org/profile; to the FDA's Manufacturers and User Facility Device Experience (MAUDE) database; and to the device manufacturer.