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FDA Sends Mixed Signals on Breast Implants

FDA questions breast implant safety reportThe Food and Drug Administration has agreed to hold a public meeting on breast implant safety while simultaneously saying that it does not agree with claims that the implants may be dangerous.

Led by Dr. Mark Clemens, researchers at the MD Anderson Cancer Center at the University of Texas had previously focused on the risks of an exceedingly rare kind of cancer of the immune system known as breast implant-associated anaplastic large-cell lymphoma, or ALCL. ALCL had been associated primarily with textured breast implants rather than those of the smooth variety because the rough variations in the textured implants could, over time, cause tissue damage and cellular abnormalities. Over the course of a decade of use, Dr. Clemens would claim that a woman’s risk of developing ALCL could be as high as one in 2,200.

However, a new analysis of breast implants in general calls the long-term safety of all types of implants into question, although researchers concede that follow-up with women who have undergone breast augmentation or reconstruction surgery has been less than ideal. More than half the 100,000 women who were enrolled in follow-up programs with the two largest implant providers – Allegan and Mentor – were out of touch with the program within three years.

The risks identified by the researchers ranged from skin disorders and rheumatoid arthritis to stillbirth and melanoma. And, with close to 100,000 records being analyzed in total, the study represents the largest analysis of breast implant outcomes to date.

Still, the FDA isn’t so sure and in announcing the public meeting used the same breath to cast doubt on the study. “We respectfully disagree with the authors’ conclusions,” said the FDA physician who leads the agency’s surgical devices division.

The reasoning for the FDA’s dismissal of the study’s findings has yet to be seen and the agency released no supplementary information in its statement. That said, it is hard to view such action through anything but a cynical and distrustful eye. As information that questions the independence of the agency tasked with keeping the American people safe from the drugs, medical devices, and foods they use continues to surface, proclamations of safety in the face of medical evidence to the contrary is bound to raise some eyebrows.