Mariel Carbone, WCPO Cincinnati: February 09, 2020
Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.
“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”
Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.
Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.
The draft warning outlines three main concerns.
First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.
It also states that implants have been associated with BIA-ALCL.
Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”
The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.
Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.
“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”
Read the original story here.