In a major reversal, the FDA has asked Allergan to recall BIOCELL® textured breast implants in the U.S. after finding 24 more deaths and a 6-fold increased risk of ALCL.
The recall comes 2 months after Allergan recalled the implants in Canada and 7 months after Allergan recalled the implants in Europe.
Last year, the FDA refused to ban Allergan’s textured breast implants because the agency did not have enough data. Now, the FDA says it has identified 33 deaths and 573 known cases of breast implant-associated ALCL — including 481 attributed on Allergan’s recalled breast implants.
Health authorities first linked textured implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.
A new study has found that silicone breast implants with a textured surface are 400-times more likely to cause a rare type of cancer compared to silicone breast implants with a smooth surface.
The FDA has released a statement that new data shows a direct link to cancer with Allergan’s implants not seen with other textured implants.
The FDA said the latest figures show more than 80% of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.
Contact a Breast Implant Lawsuit Lawyer at Shamis & Gentile, P.A. today if you believe you have a breast implant induced injury case. If you or somebody you know has been diagnosed with side effects of silicone breast implants, you should contact our lawyers immediately for a free case consultation. Please fill out a form to contact our Defective Medical Device Litigation Group. Call us at 305-479-2299 or Text Us About It at 1-833-3-TEXT-ME (1-833-383-9863).