Allergan said on Wednesday it recalled its Biocell textured breast implants and tissue expanders across marketplaces, citing concerns over an unusual type of cancer after the U.S. health agency asked the drugmaker to pull off the products.
The Food and Drug Administration (FDA) discovered the use of these breast implants was attached to the increased threat of an unusual type of cancer known as breast-implant related anaplastic large cell lymphoma.
Allergan has already quit selling the Biocell textured implants in Canada and Europe.
Breast implants come in textured as well as smooth formats, with the previous resembling sandpaper, making it less likely to move around inside breast and alter the position.
Textured breast implants are often used in Europe than in the US, with it accounting for merely10% of all breast implants sold in the nation.
Demand for Allergan’s smooth implants could also be influenced, and litigation claims may increase due to the recall, Stifel analyst Annabel Samimy mentioned; however, added that a direct impression from the recall was negligible for the corporate, which is being acquired by AbbVie for $63 billion.
Other textured implants sold in the USA are made by Sientra and Johnson & Johnson’s Mentor section.
The FDA has warned previously that risk of BIA-ALCL is higher in textured implants; however, the danger with Allergan’s Biocell textured implants is about six times compared with textured implants from other producers marketing in America, based on the data provided by the health agency.
The FDA said 573 cases of BIA-ALCL were registered globally as of July 6, out of which 481 sufferers had Allergan implants at the time of diagnosis.