UNITED STATES – The company Allergan is recalling certain types of breast implants due to a potential increased risk of cancer. The voluntary recall applies worldwide to the Allergan Biocell textured implants and Biocell textured expanders.
The recall is in response to the U.S. Food and Drug Administration providing updated safety information about the association between breast implants and anaplastic large cell lymphoma. New scientific studies show that people with breast implants might have a greater risk of developing anaplastic large cell lymphoma, which is a cancer of the immune system, not a type of breast cancer. The cancer can form in the tissue surrounding the implant or the fluid around the implant.
The FDA has received 573 reports regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL), and 481 of those reports involved confirmed use of Allergan textured implants. The FDA is also aware of 33 cases of patient death from ALCL, with 13 cases including a brand name of implant. Allergan was the manufacturer of the named implant in 12 of those 13 cases.
Though the implants are being recalled, the FDA has said that it does not recommend that patients have the implants removed if they are not experiencing any symptoms that could be indicative of lymphoma. Patients who are concerned about their implants should make appointments with their doctors and should find out if they have implants that have been recalled by Allergan.
The recall includes, but is not limited to, the following textured implants and expanders:
- Natrelle Saline implants
- Natrelle and McGhan 410 implants
- Natrelle and McGhan 410 Soft Touch implants
- Natrelle 510 Dual Gel implants
- Natrelle Inspira implants
- Natrelle Ritz Princess implants
- Natrelle 133 expanders
- Natrelle 133 Plus expanders
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