Cosmetic Treatments

October 27, 2019

As FDA warns of implant perils, new questions arise about 3D mammograms

Angry women, anxious that officials were failing to protect their health, besieged a federal Food and Drug Administration hearing in the spring. That unusual outcry may have helped push regulators off their bureaucratic backsides, getting them finally to warn about risks of one of the most commonly used medical devices for women: breast implants.

But will a similar gender uprising be required to quash a rising and dubious medical testing of women, the so-called “3D mammogram?”

The FDA’s sudden, fast stepping on breast implants is occurring after years of inaction. Under new rules proposed by the agency, the devices’ packaging would be required to carry “boxed warnings,” the FDA’s most serious caution. The agency also would call on surgeons to step up their discussions with women about implant risks, including for rare cancers. As the Washington Post reported, doctors also would be told to tell patients:

July 30, 2019

Voluntary recall of textured device raises more alarms about breast implants

by Patrick A. Malone

An Irish medical manufacturer voluntarily withdrew its textured breast implant and related tissue expanding devices from markets after the federal Food and Drug Administration tracked a spike in a rare cancer and deaths tied to the products and asked that they be recalled.

U.S. regulators, the New York Times reported, lagged their European counterparts by almost a year in acting to protect women seeking cosmetic and reconstructive procedures involving the Allergan implant:

“Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.”

March 19, 2019

$29 million jury verdict in talc case underscores need for asbestos regulation

by Patrick A. Malone

Although research has shown that asbestos can cause cancer and other harmful illnesses and the federal government has sought to limit and even ban its use, yet another sizable judgment in a tainted talc case and the discovery of the substance in a popular cosmetics line shows how America’s oversight and regulation of risky materials can be too slow and ineffective.

As the New York Times reported, a jury in the San Francisco area has joined similar deliberative panels in accepting claims that longtime use of Johnson & Johnson baby power causes cancers. The state jury decided that J&J must pay plaintiff Teresa Leavitt a total of $29 million because the company knew its talc was tainted with asbestos but failed to warn her and others. Leavitt, who used the product for three decades, was diagnosed in 2017 with mesothelioma, a cancer of the lining of internal organs that is associated with asbestos.

The newspaper said the jury told J&J to pay her “$22 million for her pain and suffering, $5 million to compensate her family members, nearly $1.3 million for her medical costs and $1.2 million for her lost wages.”

December 17, 2018

Johnson & Johnson hid knowledge of talc’s taint with asbestos, reports say

by Patrick A. Malone

Johnson & Johnson, now facing thousands of lawsuits asserting ties between its famed baby powder and patients’ cancers, has campaigned for decades to keep from wide public view information that its talc was tainted with asbestos, a naturally occurring substance and an established cause of some cancers, news media reports say.

Reuters news service published its investigation of J&J’s long efforts to deny and downplay scientific evidence it had about asbestos in a product that has helped to create and define the company as one of the nation’s family friendly consumer product and pharmaceutical giants.

Tens of millions of Americans grew up, with grown-ups dusting them as infants with Johnson’s baby powder, now contributing just “$420 million to J&J’s $76.5 billion in revenue last year,” Reuters reported.

June 28, 2018

No surgery is free of risks or complications, as breast reconstruction study reminds

by Patrick A. Malone

Cancer and surgery — it’s little wonder that even the most resilient patients can buckle a bit when their doctors talk to them about these two issues together and urgently. That’s why new research may be valuable to women with breast cancer, providing them with better evidence-based insight about challenges in their reconstructive options.

The information, which experts said surprised them and may change their views on frequently performed procedures, yet again underscores that surgery can carry significant risks and complications.

In fact, 1 in 3 women who undergo cancer-related breast reconstructive surgery develops a postoperative complication over the next two years, 1 in 5 requires more surgery, and in 1 in 20 of cases, reconstruction fails, the New York Times reported of the published findings of medical researchers, most from the University of Michigan.

June 20, 2018

Lasik surgery: a study in medical risks, complications, lack of official followup

by Patrick A. Malone

Caveat emptor, federal officials are reminding patients anew about an eye surgery that tens of millions of Americans already have undergone and all too many may believe ── wrongly ── is all but risk-free.

In fact, significant numbers of the 9.5 million Americans who had laser-assisted operations, the so-called Lasik procedure, may show vision improvements, but they also may be under-reporting problems connected with their surgeries, the New York Times reported.

The federal Food and Drug Administration approved Lasik in the 1990s, but the agency only recently has supported the gold-standard of medical research, a randomized clinical trial, to check in on long-running complaints about the surgery.

January 18, 2018

President O? Let’s first look hard at her role in hyping health humbug

by Patrick A. Malone

Oprah Winfrey’s recent rousing broadcast speech — both in accepting an entertainment industry group’s lifetime achievement award and denouncing sexism and sexual harassment in Hollywood — also opened the door to a reconsideration of how this talented, smart, accomplished, powerful, and wealthy celebrity icon long has helped to foster a barrage of health and medical humbug, spreading it far and wide in popular culture.

As Stat, a health and information site, recapped about Winfrey:

She connected a cancer patient to ‘junk science,’ a Washington Post analysis says. She promoted charlatans on her show, according to Slate. Former Arkansas governor Mike Huckabee put out a statement … attacking Winfrey for ‘giving a platform to anti-vaccination campaigners and other dangerous health quackery.’

December 22, 2017

It’s not a stretch: Avoid those over-use boo-boos, older yogis are warned

by Patrick A. Malone

For seniors who may be rushing to squeeze in a few more pretzel-twisting sessions to ease their stress from a hectic holiday season, this is a gentle reminder: Take it easy with the yoga. It can be good for you, but don’t overdo it or you may hurt yourself.

The Washington Post reported that the number of yoga devotees has climbed to an estimated 36.7 million Americans, many of whom find that stretching and posing in various styles makes them breathe and feel better, as well being more limber, focused, and relaxed. Yoga also has special appeal to older practitioners, 17 percent of them in their 50s and 21 percent 60 and older, according to a study conducted by a yoga publication.

But public health researchers from the University of Alabama Birmingham, after examining electronic data on almost 30,000 yoga-related injuries that led patients to emergency room treatment between 2001 and 2014, reported that:

November 10, 2017

Some straight dope on pot products, soy foods, essential oils, stem cell hype

by Patrick A. Malone

Let’s give them their just deserts and dispatch them with alacrity. In this week’s hokum alert:

The federal Food and Drug Administration couldn’t make it clearer: Companies pushing products with cannabis in them can’t make unfounded claims about their use in treating or “curing” cancer. It’s just rubbish. The agency ordered the makers of dozens of pot-containing products to stop their hype. Savvy consumers also should stop acting as if they’re stoned and giving any credibility to these claims, right?
The rightly red-faced FDA itself is walking back some of its gullibility about health claims for soy foods and their purported heart healthfulness. The Weston A. Price Foundation, a nonprofit organization that supports good nutrition, called out the agency, pointing out that recent research demonstrates at best a correlation between soy eating and good heart health. The FDA, which had allowed just a dozen claims of health benefits on food packaging, decided soy’s benefits are insufficient to stay in this glowing group (which includes Vitamin D in cutting osteoporosis risks and fruits and vegetables in cancer reductions). Just to be clear: soy isn’t harmful, it is popular (notably in Asian-based diets), and it is a sound, plant-based protein.

November 3, 2017

Elmo and George Washington University get caught up in researcher-PR hype

by Patrick A. Malone

Elmo and the Colonials won’t make it as a new Saturday morning hit cartoon show. But the colorful characters might play a tangential part in some important lessons for consumers and some supposedly serious institutions on preserving the public trust in published, medical-scientific research.

Healthnewsreview.org, a nonprofit and independent watchdog of health information, rightly has taken George Washington University to task for issuing a Pollyannaish, inaccurate news release on a Colonials’ study on whether text messages could help curb expectant moms’ smoking. The hype from the school, about research from GWU’s Milken Institute School of Public Health, first proclaimed:

Text messaging program may help pregnant women kick the smoking habit