In December 2018, Allergan’s textured breast implants were recalled in Europe due to them being linked to a rare form of cancer called Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL).
On the 8th February 2019, after two days of public hearings investigating the safety of these medical devices, an expert committee set up by the French regulator Agence Nationale de Securitie du Medicament (ANSM), recommended a permanent ban on the sale of Allergan textured breast implants in Europe. The expert committee cited concerns about the adverse health effects associated with these breast implants used in cosmetic and reconstructive surgeries, including a rare form of cancer BIA-ALCL which is associated with textured breast implants in general. ANSM also cautioned surgeons and patients about using other brands of textured implants.
The cancer is a type of non-Hodgkin's lymphoma and manifests as a malignancy of the cells of the immune system that develops years after the implant surgery occurred. Removing the implant usually eliminates the disease. However, in some cases, if left untreated the cancer can spread throughout the body and become life threatening. Based on current data from the U.S. Food and Drug Administration (FDA), textured breast implants carry a greater risk of BIA-ALCL than smooth implants. The most common test for ALCL is to remove a sample of an enlarged lymph node and check it for lymphoma cells. General symptoms may include a collection of fluid around the breast, pain, itch, lumps and swelling in the breast, loss of appetite and tiredness. Following the ban recommended by the ANSM, the FDA has stated there are now 457 women in the U.S. diagnosed with BIA-ALCL. There have been more than 600 cases including sixteen women who have died of BIA-ALCL reported worldwide.
As of the 18th February 2019, the Health Product Regulatory Authority has yet to respond on its website to the most recent recommendations made by ANSM in respect of the permanent ban.
Understandably, many women who have Allergan breast implants are concerned about whether they are at risk of contracting BI-ALCL. Cantillons Solicitors is investigating potential legal claims for those affected by these implants.
Contact us at Cantillons Solicitors at +353 (0)21 -4275673 or [email protected] if you would like more information.
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