Patient Safety News: FDA Meets on Breast Implants Associated with Causing Cancer
The U.S. Food and Drug Administration (FDA) held a two-day meeting in March 2019 to hear from patients, physicians, manufacturers and other experts about the risk that certain breast implants have in causing cancer. The FDA has received notice of 457 cancer cases from women with the implants through last year. The purpose of the hearings is to determine whether the implants should be banned and what kind of warnings manufacturers should be mandated to provide in the meantime.
Scores of women testified at the hearings about getting sick and that their plastic surgeons only warned of routine risks from the implants. The discussion among experts also revolved around the effects of different types of implants and whether textured devices, which are preferred by some surgeons, also are accompanied by a higher risk of cancer.
These patients have not actually been diagnosed with breast cancer; instead the women effected have a form of lymphoma called anaplastic large cell lymphoma, a slow-moving disease that attacks the immune system. The FDA first announced the link between breast implants and the development of anaplastic large cell lymphoma in 2011 and in 2016 he World Health Organization determined the breast implants could lead to this cancer.
“It is outrageous that women’s health is disregarded when the evidence is overwhelming and unequivocal that these breast implants cause cancer,” Berman & Simmons attorney Susan Faunce said. “How many more women need to get sick or worse, die, because the FDA is failing to regulate these devices?”
Attorney Faunce leads the firm’s mass tort practice and is pursuing claims for compensation on behalf of patients who have developed serious complications from dangerous drugs and medical devices.