Friday, December 27, 2019

Allergan hit in piece on agency's foot-dragging

'Consumer Reports' blasts FDA and continuing risk of silicone-filled implants for breast reconstruction

Allergan, which manufactures silicone-filled breast implants with a textured surface, has come under fire by "Consumer Reports" because of the danger the devices present.

In an unsigned article in CR's December issue, the magazine — which noted that medical items such as pacemakers, artificial joints and implants — "are subject to much less rigorous premarket testing than drugs are."

Diana Zuckerman, Ph.D.
The result? According to Diana Zuckerman, Ph.D., president of the National Center for Health Research, "silicone breast implants were introduced in the 1960 with little or no safety research."

In fact, the piece also asserts, the Federal Drug Administration "didn't begin regulating medical devices or requiring research on their efficacy and safety until 1976, after many devices were already in use."

Even then, CR continues, "the agency didn't require premarket studies until 1991 — when it determined there was insufficient safety research, and soon after put a moratorium on sales."

In 2006, the FDA finally approved silicone implants, which are often used for reconstructive surgery — but only on the condition that manufacturers conduct post-market studies. 

Still, according to the "Consumer Reports" piece, "more problems emerged" and in 2011 the FDA "announced a link between silicone- and saline-filled implants and a form of cancer called anapestic large cell lymphoma (ALCL)."

Although Allergan's research into the device was abruptly halted — without the FDA penalizing or requiring a recall by the manufacturer.

In 2010, the FDA, after learning of "a significant increase" in known cases of of ALCL (aka BIA-ALCL), finally requested a recall (eight years after the agency had acknowledged a risk).  But there's still no system for "manufacturers to find and notify doctors and patients about a recall."

Also, the magazine contends that although Allergan "will pay for replacement implants in the case of a cancer diagnosis or implant defect, it doesn't cover the surgical costs of preventive implant removal. Most insurers won't cover it, either."

For more information on reconstruction and implants, pick up a copy of "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

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