'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.|
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.