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.

Quashing negative emotions may help healing

New Taiwan study finds that music might lessen pain, fatigue, appetite problems of breast cancer patients

Listening to music at home may reduce breast cancer patients' pain and fatigue.

At least in the short run.

That activity, according to a recent story by Carolyn Crist in Reuters Health, can also "ease symptoms like loss of appetite and difficulty concentrating."

Research in Taiwan, the article continues, found that breast cancer patients "assigned to 30 minutes of music listening five times a week had 'noticeably' reduced side effects of cancer and its treatment over 24 weeks."

A report on the study appeared in the European Journal of Cancer Care. 

Why did the music help?

Crist's piece says it aided patients physical and psychological well being "because it distanced them from negative thoughts about cancer."

Professor Kue-Ru Chou

Kuel-Ru Chou, professor in the School of Nursing at Taipei Medical University, senior author of the study that looked at 60 patients, notes that "music therapy is convenient, does not involve invasive procedures, and can easily be used by people in the comfort of their homes."

Home-based "music interventions," she continued in an email to Reuters Health, "can also be used with no cost." 

The study offered patients a choice of classical, pop, Taiwanese and religious music. 

A control group could only select from environmental sounds, which, Crist's story says, "research has shown does little to reduce pain or symptoms"

There is a caveat about the benefits of music, however.

Based on the study's findings, Crist writes, "music therapy may not relieve long-term physical and mental fatigue."

The scribe also explains that the study's authors speculate "because listening to music promotes endorphins, dopamine and serotonin in the brain, the chemicals may spark joy and positive emotions that distract patients from the negative emotions."

In addition, the authors maintain, "music could affect functions of the cardiovascular, respiratory, muscular, skeletal, nervous and metabolic systems as well, relieving muscle tension and pain."

Healing benefits of other things, such as humor, are addressed in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.