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.

Valsartan, larsartan, irbesartan risks cited

Finding cancer-causing contaminants causes FDA to recall blood-pressure drugs 

Millions of bottles of generic blood-pressure meds have been recalled after a contaminant that causes cancer was found.

According to a recent story on the Tech2.org website, the Federal Drug Administration (FDA) ordered the recall after determining that folks who've taken certain hypertension meds over the past four years may have been exposed to small amounts of impurities following a change in the way companies manufacture the active ingredient.

The carcinogens, the article continues, "are a chemical byproduct of the process used to synthesize the active ingredients in medicines, which includes valsartan, losartan and irbesartan."

Agency leaders, the story says, have estimated that "between 1 and 2 million people may have taken the drugs with the impurities."

The recalled products, a USA Today story says, "are part of a large class of drugs called angiotensin II receptor blockers, or ARBs, which relax blood vessels. Many of these commonly prescribed drugs are not part of the recall."

But, overall, "the risk to individual patients remains very small, although this doesn't diminish the significance of this episode or our concerns," read a joint statement from FDA Commissioner Scott Gottlieb and FDA Director Janet Woodcock.

David Light

David Light, founder and chief exec officer of Valisure, an online pharmacy that chemically validates the drugs before shipping them to consumers, said "companies may not be cleaning the active ingredients as a cost-saving measure," noting, too, that "it would not have been unexpected that the synthesis process would cause pollutants."

Details on risks of drugs that might worsen medical conditions can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a book that I, Woody Weingarten, aimed at male caregivers.