Product News and Recalls

Dissatisfaction Intensifies Over FDA Inaction on Breast Implant Cancer

dissatisfaction continues over FDA response to breast implant cancerInvestigations into the growing body of evidence indicating a link between breast implants and a certain type of breast cancer are showing a troubling common thread: a complete lack of warning for the patient over the danger.

Numbers seem to support the notion that the decision to receive breast implants is made without much; if any, concern over personal health. 75 percent of the 400,000 breast implant procedures conducted each year are for cosmetic reasons while only the remaining 25 percent are the result of post-cancer treatment reconstruction.

One woman who offered her story to the FDA committee currently investigating the link left no room for interpretation of her statement. “I was not warned” about any risks that might be associated with implants, said Jamee Cook. Years would go by as the former ER paramedic suffered through swollen lymph nodes, fatigue, and a constant low-grade fever. It wasn’t until she had the implants removed that most – but not all – of her symptoms went away.

The cancer – a specific type known as breast implant-associated anaplastic large cell lymphoma – is mostly associated with textured breast implants. However, a growing number of women who have received smooth implants are also reporting instances of the disease. In addition to cancer, various forms of autoimmune responses are being seen that include joint and muscle pain, allergic reactions, and fatigue.

The growing number of adverse events associated with breast implants has received so much attention that a new term is being used to collectively describe them. “Breast implant illness” is now the descriptor used to warn of the dangers of side effects from a procedure that used to be considered with almost no hesitation. As a result, hundreds of women are threatening lawsuits and thousands more have had enough with FDA “investigations” and want the agency to take regulatory action. To some, the delay borders on the absurd.

In the face of growing scientific evidence and data, Diana Zuckerman, president of the National Center for Health Research calls the FDA’s stance “close[d]-minded.” “We have always said that we don’t know what the percentage is,” she says. “Just that for women who are sick, getting [the implants] out makes them better.”

In the meantime, as the FDA lumbers forward gathering evidence, more women than ever face the dangers and uncertainty of a decision made years ago.