This is an update to the safety alert on "Association between Breast Implants and Anaplastic Large Cell Lymphoma (ALCL)" issued on 23 December 2016. [https://www.mdco.gov.hk/english/safety/recalls/recalls_20161223a.html]
According to a recent Safety Communication issued by the United States Food and Drug Administration (FDA), medical device manufacturer, Allergan, was requested by the FDA to voluntarily recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports reporting worldwide cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.
The affected products, sold under the brand names Inamed, McGhan and NATRELLE are identified as follow:
This recall does not affect the manufacturer's NATRELLE smooth or MICROCELL breast implants and tissue expanders.
BIA-ALCL is a type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after a breast implant procedure. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. While the cause is unknown, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.
The FDA's analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.
Based on the currently available information, including the newly submitted data, FDA's analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan's BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.
At this time, the FDA does not recommend removal of these or other types of breast implants in patients who have no symptoms due to the low risk of developing BIA-ALCL.
The Medical Device Control Office has followed up with the local suppliers and noted that the local suppliers have notified all affected hospitals and plastic surgeon customers regarding the recall. The customers are required to identify and immediately quarantine the affected products. They should no longer implant the affected products and all unused products should be returned to the local suppliers.
Patients are advised to speak with their plastic surgeons regarding any questions they have about the risks and benefits of their implant type should they have any concerns.
According to the local supplier, the affected products are distributed in Hong Kong through Y.C. WOO & Company Limited previously and Caster (HK) Medical Supplies Company Limited.
If you are in possession of the products, please contact your suppliers for necessary actions.
For details related to the advice given by the FDA, please refer to the following link:
https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue
Posted on 5 September 2019