On July 24, US time, Allergan's official website issued an announcement that biopel breast implants and tissue dilators were voluntarily recalled worldwide. "BIOCELL brine-filled and silicone-filled plush breast implants and tissue expanders will no longer be distributed or sold in any of the markets currently covered."
At the same time, the official website also said that the FDA (United States Food and Drug Administration) does not recommend that patients without symptoms remove or replace the hairy breast prosthesis, and said that the smooth and microporous breast prosthesis and tissue dilator are not affected.
Previously, the US FDA issued a notice saying that in order to protect individuals from the increased risk of mammary transplant-related anaplastic large cell lymphoma (BIA-ALCL), as these risks are related to breast implants of Allergan's product BIOCL fur technology, the US Food and Drug Administration (FDA) asked Allergan to recall its BIOCELL breast implants and tissue dilators.
Breast prosthesis-associated anaplastic large cell lymphoma (BIA-ALCL), a rare specific type of lymphoma, was discovered in 2011 and is currently affected by 573 people worldwide, 80% of whom have used Allergan's hairy breast prosthesis (a prosthesis with a rough surface that does not slide easily in the body, but constant friction causes tissue inflammation), and 33 deaths, of which 15 have used this prosthesis.
According to Allergan China's official website, the global recall does not affect Allergan's Naqili glossy breast prosthesis and MICROCELL breast prosthesis and tissue expander. Allergan's two breast implant products listed in China are Natchelle and McGonagall, and The products of Naqili and McGonagall are divided into rough surface and glossy surface, and the recall is the wool product, and the glossy surface is not affected.
Domestic breast experts discussed the release, the incidence of BIA-ALCL is extremely low, the country has not yet seen reports, and it is currently believed that the overall safety of breast prostheses does not affect. Patients who have been implanted with prostheses do not need to worry too much, and regular follow-up examinations are recommended, and if breast enlargement or lumps and other abnormalities are found, they should see a doctor in time.
Since 2014, our section has largely not used the fur prosthesis of McGonagall and Naqili involved in the recall. Here to remind you that beauty seekers after breast implant augmentation recommended to review once a year (physical examination + B ultrasound), if necessary, nuclear magnetic resonance imaging (MRI) examination, fda recommends that 3 years after surgery every 2 years for MRI examination, according to the domestic situation recommended that 8-10 years must be done MRI, and then every 2 years to do it, in order to find problems in time and solve them as soon as possible.