FDA Recalls Breast Implants Which Are Linked To A Rare Cancer
The Food & Drug Administration has recalled, textured breast implants that were made by Allergan. The FDA also announced that the implants will be recalled globally. The Allergan devices were banned in Europe late last year. The disease which the implants are linked to is anaplastic large cell lymphoma, a rare cancer of the immune system.
The disease develops in the tissue around the implant however it is not breast cancer. If detected early, removing the implant and the scar tissue around it can cure the cancer, however if not detected it can spread and kill the patient. Worldwide, there have been 573 cases of this cancer and 33 deaths reported. Four hundred and eighty one of the cases, are clearly attributed to the Allergan Biocell implants. The FDA reported that of the 33 deaths, the type of implant was known in thirteen cases, twelve of which involved Allergan.
Dr. Jeffrey Shurman, the Director of the FDA Center for devices and radiological health stated “that the data regarding the deaths was particularly informative of our decision”.
In the U.S. breast enlargement is the most popular type of plastic surgery. In 2017 there were more than 300,000 elective breast enlargement surgeries in the United States. There was an additional 100,000 implant surgeries during reconstructive surgery after mastectomies for breast cancer.
For over 20 years, David R. Heffernan, has been an advocate for those injured due to negligence including medical malpractice, wrongful death, personal injury, automobile and trucking accidents, pharmaceutical and products liability and premises liability. He has obtained numerous seven-figure settlements and verdicts for his clients and is dedicated to helping the injured people of Miami receive compensation for their injuries.