FDA Orders ‘Black Box’ Warning Label on Essure Long-Acting Contraceptive

By Dennis Thompson
HealthDay Reporter

MONDAY, Feb. 29, 2016 (HealthDay News) — A special “black box” warning should be added to packaging for the Essure implantable birth control device, based on concerns over serious complications, the U.S. Food and Drug Administration announced Monday.

The FDA also ordered Essure’s manufacturer, Bayer, to conduct a new clinical study to gather more data about the health risks the device might pose for “in a real-world environment.”

Essure is a permanent and nonsurgical form of birth control for women. It consists of flexible coils that are inserted through the vagina and cervix into the fallopian tubes, the FDA explained in a statement.

Scar tissue forms naturally around the coils, creating a barrier intended to prevent sperm from reaching the egg as they travel down the fallopian tubes into the uterus.

However, since the FDA approved Essure in 2002, the agency says it has received about 10,000 complaints about the device.

Complications from using Essure can include pain, abnormal bleeding, allergic reaction and tearing of the uterus or fallopian tubes if the device migrates, the FDA said.

Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, spoke about Essure during a news briefing late Monday. He said that the agency has also received 631 reports of women becoming pregnant while using the product, and 294 reports of pregnancy losses.

Still, Maisel said, “it’s important for women to know that Essure is extremely effective at preventing pregnancy. However, in order for it to be effective, the device must be placed properly and women must rely on an alternative form of birth control until they undergo an Essure confirmation test.”

According to Maisel, “like all forms of birth control, Essure is not perfect and women may become pregnant despite use of the device. The lack of an Essure confirmation test is the most common factor contributing to unintended pregnancies in women with Essure.”

Some have alleged that clinical trial records that led to Essure’s approval were altered to favor the device, but Maisel said that an FDA re-analysis of the evidence has concluded these charges are baseless.

“In the end, our analysis did not find evidence of systematic or intentional modifications of study subject responses,” he said. “The agency believes the original clinical data relied upon represents valid scientific evidence.”

In addition to the boxed warning, the FDA also wants Bayer to include a “patient decision checklist” in Essure’s packaging, “to ensure women receive and understand information regarding the benefits and risks of this type of device.”

The checklist would be reviewed and signed by the patient and her doctor. It goes over a series of health issues that should deter a woman from using Essure, and requires that she promise to return to her doctor in three months to make sure the device has been properly placed.

The clinical trial ordered by the FDA will assess rates of complications with Essure and compare them to the complications associated with tubal ligation.

The study also will evaluate how complications affect a patient’s quality of life, and identify reasons why women don’t come back for follow-up testing three months after insertion to make sure that Essure has been properly placed.

The public and industry will have 60 days to comment on this draft guidance from the FDA, the agency said.

More information

Visit the U.S. Food and Drug Administration for more on Essure.

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Young Athletes Pressured by Parents May Resort to ‘Doping’

MONDAY, Feb. 29, 2016 (HealthDay News) — Young male athletes under parental pressure to succeed are more likely to use banned substances to boost their sports performance, a new study finds.

Researchers at the University of Kent in England asked 129 young male athletes, average age 17, about their attitudes on “doping” — the use of prohibited drugs, such as steroids, hormones or stimulants, to boost athletic ability.

These substances, sometimes called performance-enhancing drugs, can potentially alter the human body and biological functions. However, they can be extremely harmful to a person’s health, experts warn.

In addition, the study participants were also asked about four different aspects of perfectionism. The four areas were: parental pressure; self-striving for perfection; concerns about making mistakes; and pressure from coaches.

Only parental pressure was linked to positive feelings about doping among the athletes, the study authors found.

The findings suggest parents need to recognize the consequences of putting too much pressure on young athletes, said lead researcher Daniel Madigan, a Ph.D. student in the university’s School of Sport and Exercise Sciences.

“The problem of pressure from parents watching their children play sports is widely known, with referees and sporting bodies highlighting the difficulties and taking steps to prevent it,” Madigan said in a university news release.

“With the rise of so-called ‘tiger’ parenting — where strict and demanding parents push their children to high levels of achievement — this study reveals the price young athletes may choose to pay to meet their parents’ expectations and dreams,” Madigan added.

The study findings are scheduled for publication in the April print issue of the Journal of Sports Sciences.

The researchers plan to investigate if the same problem occurs in young female athletes, and if there are differences between athletes in team versus individual sports.

More information

The U.S. Anti-Doping Agency outlines the side effects of performance-enhancing drugs.

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How to Sculpt a Waist and Booty Like Sofia Vergara’s

Photo: Getty Images

For some, Sofia Vergara left her fashion mark on the Academy Awards red carpet in that gorgeous navy Marchesa dress. For others, it was all about that white, body-hugging Mark Zunino number she donned at Vanity Fair’s post-Oscars bash. Either way, one thing is clear: Vergara sure does know how to play up her, ahem, assets.

Longing for the Modern Family star’s killer curvy frame? We’ve got moves from two of her trainers for you to try. Ready, set, sweat!

For your waist

Trainer: Anna Kaiser

Go-to move: The Waist Cincher, because “a small waist helps accentuates those gorgeous curves,” says Kaiser.

How to do it: Stand with feet a little wider than hip-width and hands at sides. Bend knees slightly and then reach right hand over as far as possible to the left as you rest your left forearm on left thigh. Reverse motion; as you return to start, bend left knee, lifting left foot behind right leg so that your right hand and left sole touch. Simultaneously, reach left hand over to right as far as possible. This is one rep. Continue alternating sides. Do 10 total reps.

RELATED: The Hilarious Way Sofia Vergara Stays Motivated to Work Out

For your booty

Trainer: Gunnar Peterson

Go-to move: High Knee Step-Ups, because they challenge your balance, forcing each butt muscle to work individually, says Peterson.

How to do it: Stand facing a bench and step your left foot up onto it. Press into your left foot to come to standing one-legged on the bench while quickly raising right knee to chest level. Swiftly lower right leg back down. Perform 10-20 reps, then switch legs and repeat. Do 2-5 sets two to three times a week for a stronger, firmer booty in two to three weeks.

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Lack of Sleep May Give You the ‘Munchies’

MONDAY, Feb. 29, 2016 (HealthDay News) — Lack of sleep may give you the “munchies,” a small study suggests.

Sleep deprivation appears to boost levels of a chemical that makes eating more pleasurable — similar to the effects of marijuana, University of Chicago researchers said.

“We found that sleep restriction boosts a signal that may increase the hedonic aspect of food intake, the pleasure and satisfaction gained from eating,” Erin Hanlon, a research associate in endocrinology, diabetes and metabolism, said in a university news release.

Previous research has linked too little sleep with overeating, unhealthy food choices and weight gain, but the reasons for the connection were unclear, the researchers explained.

This study found that sleep loss increases blood levels of a chemical signal called endocannabinoid 2-arachidonoylglycerol (2-AG). It enhances the joy of eating, particularly sweet, salty and fatty snack foods, according to background notes with the study.

For the study, 14 young and healthy volunteers were monitored. The researchers tracked their hunger and eating habits in two time periods: four days when the participants received about 7.5 hours of sleep nightly, and four days when they averaged only 4.2 hours of sleep.

When sleep-deprived, the volunteers’ 2-AG blood levels rose and remained high through the evening. When they had access to snacks, they couldn’t resist cookies, candy and chips, even though just two hours earlier they had had a meal that provided 90 percent of their daily caloric needs. They also consumed twice as much fat as when they had gotten a good night’s sleep, the researchers said.

Their appetites for unhealthy treats were strongest in the late afternoon and early evening, times of the day when snacking has been linked to weight gain, according to the study published Feb. 29 in the journal Sleep.

“Sleep restriction seems to augment the endocannabinoid system, the same system targeted by the active ingredient of marijuana, to enhance the desire for food intake,” Hanlon said.

The findings support previous research and apply to “normal life conditions,” she added.

For example, “if you have a [candy] bar, and you’ve had enough sleep, you can control your natural response,” Hanlon explained. “But if you’re sleep-deprived, your hedonic drive for certain foods gets stronger, and your ability to resist them may be impaired. So you are more likely to eat it. Do that again and again, and you pack on the pounds.”

More information

The U.S. Centers for Disease Control and Prevention has more about sleep.

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Daylight Saving Time Tied to Brief Spike in Stroke Risk

By Amy Norton
HealthDay Reporter

MONDAY, Feb. 29, 2016 (HealthDay News) — Changing the clocks for daylight saving time may cause a short-lived spike in some people’s risk of suffering a stroke, a preliminary study hints.

Looking at a decade’s worth of stroke data, Finnish researchers found that the national incidence of stroke tended to rise slightly over the two days following daylight saving time transitions — whether the clocks were turned forward or back.

The findings do not prove that daylight saving time is to blame.

On the other hand, it’s hard to imagine other factors that would explain such a specific pattern, said researcher Dr. Jori Ruuskanen, a neurologist at Turku University Hospital.

Plus, he said, there is a known link between disruptions in the body’s circadian rhythms and stroke risk. Circadian rhythms refer to the shifts in the body’s biological processes that happen over 24 hours — largely in response to light and darkness.

Those rhythms can be thrown off in different ways, Ruuskanen said. Shift work and insomnia are two examples, he noted, and both have been tied to increased risks of health conditions, including stroke.

Ruuskanen is scheduled to present the findings in April at the American Academy of Neurology’s annual meeting in Vancouver, Canada. Research presented at meetings is considered preliminary until published in a peer-reviewed medical journal.

Dr. Andrew Lim is a neurologist at Sunnybrook Health Sciences Center, in Toronto, who studies sleep and circadian rhythms. He agreed that daylight saving time could plausibly affect stroke risk.

“Sleep is associated with many physiological changes that are normally thought of as being relatively protective against stroke, like lower blood pressure,” explained Lim, who was not involved in the new study.

When sleep is disrupted, he said, there may also be shifts in those protective biological processes.

For the study, Ruuskanen’s team looked at Finnish stroke figures for the years 2004 to 2013. The investigators then compared just over 3,000 people who’d been hospitalized for an ischemic stroke during the week after a daylight saving transition with nearly 12,000 people who’d suffered a stroke in the two weeks before or after a transition week.

Ischemic strokes are caused by a blood clot in an artery supplying the brain, and they account for 87 percent of all strokes, according to the American Stroke Association.

Overall, the researchers found, stroke incidence was 8 percent higher during the first two days after a daylight saving transition.

Adults older than 65 and people with cancer seemed particularly vulnerable: They were 20 percent to 25 percent more likely to have a stroke right after a daylight saving transition, versus the other time periods studied.

Ruuskanen emphasized that the study found a small increase in strokes at the population level — which means that for any one person, daylight saving time transitions would not have a big impact on stroke risk.

And it’s not that a clock change would trigger a stroke in someone who would otherwise have remained healthy. “This probably means that any ‘extra’ strokes occurring after the daylight saving change would otherwise have occurred some time later,” Ruuskanen said.

Lim agreed that the risk has to be kept in perspective. “In the big scheme of things, the increase in risk is small and transient,” he said, “and the effect of other factors, such as managing blood pressure, is more important.”

That said, Lim added, some planning may help people minimize any sleep disruptions. “It may be generally helpful to adjust gradually to daylight saving time rather than all at once,” he said.

March 13 is the day when clocks spring forward an hour this year. So, people could try going to bed and waking up 15 minutes earlier than normal on the Thursday before, Lim said. On that Friday, bump that up to 30 minutes, and then aim for 45 minutes on that Saturday, he added.

According to Ruuskanen, there is one way to prove whether daylight saving time truly contributes to strokes: “If we, in our country, abandoned daylight saving time and, in a follow-up of several years, saw that the small increase in stroke incidence disappears, it would make a strong argument that it actually is the clock change that raises stroke risk,” he said.

More information

The American Stroke Association has more on stroke risk factors.

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For Cancer Patients, Pain May Rise as Finances Dwindle

By Dennis Thompson
HealthDay Reporter

MONDAY, Feb. 29, 2016 (HealthDay News) — Cancer patients skating near financial ruin will likely suffer more pain and worse symptoms than those who have some savings to fall back on, a new study reports.

Lung or colon cancer patients with two or fewer months of financial reserves had a significantly poorer quality of life than those who had more than a year of funds, according to a study involving more than 3,400 patients.

Patients already stretched thin financially at the time of diagnosis tended to have worse overall health, more pain, greater physical impairment and deeper depression than those with more money on hand, the researchers reported.

A person’s suffering tended to increase as finances dwindled, said study lead author Dr. Christopher Lathan, medical director of the Dana-Farber Cancer Institute at St. Elizabeth’s Medical Center, in Boston.

“There was a very clear relationship,” Lathan said. “The less financial reserve you had, the greater impact it seemed to have on all these measures.”

The study findings were published Feb. 29 in the Journal of Clinical Oncology

Previous studies have shown that income level and access to quality health insurance can dictate your likelihood of surviving cancer, Lathan said.

But a high income doesn’t necessarily mean you’re living within your means, nor does a low income preclude saving money for a rainy day, Lathan noted. So he and his colleagues decided to focus on a person’s financial strain and the effect it has on their cancer.

They gathered data from a cancer outcomes study involving more than 10,000 patients diagnosed with lung or colon cancer between 2003 and 2005. They whittled their pool of patients down to 3,419 who were willing to complete a follow-up interview that included questions about household finances.

About 40 percent of lung cancer patients and 33 percent of those with colon cancer reported limited financial reserves.

The researchers said they found that financial strain had enough impact to be an independent risk factor for increased pain and symptoms, even after taking into account race and household income — two variables closely related to finances that also affect quality of life during cancer treatment.

Financial strain “stands alone,” Lathan said. “It actually had its own effect, separate from race and income.”

The make-or-break point appeared to be two months. “The people at the highest risk were those at the lowest category, which is they could not make it two months or less,” Lathan said.

Exactly why isn’t clear, he said. It could be that people with bad finances find it tough to access quality health care from the start, and delay treatment because they can’t get to the right medicines or the best doctors, Lathan said.

However, it’s also possible these people start out with access to good cancer care, but their access slips away as cancer expenses quickly burn through their money, he said.

The stress that comes from financial insecurity also can play a role, said Dr. Lowell Schnipper, a professor at Harvard Medical School in Boston and chair of the American Society of Clinical Oncology’s Value in Cancer Care Task Force.

Stress is “tightly connected to perceptions of pain,” Schnipper said, noting cancer patients face “intense worry because of all the other obligations people have caring for themselves through what could be a mortal illness.”

The medical community can take steps to assist financially strapped cancer patients, Lathan and Schnipper said.

Social workers in cancer wards can help these patients navigate the complicated medical system, find clinical trials, and overcome basic difficulties such as transportation to treatment and keeping track of their prescriptions, Lathan said.

“You don’t have to fix all of the financial problems of a person,” he said. “You just have to provide some targeted intervention that might have the maximum impact on their outcome.”

Social workers also can help patients sign up for programs that provide free chemotherapy drugs to those who can’t afford the total cost of the drugs or even the copay, Schnipper added.

But first, doctors need to know that the patient has financial problems.

“We should probably be asking that of people when they come to see us,” Lathan said, suggesting financial questions be part of a patient’s initial workup.

More information

For more information on managing cancer care, visit the U.S. National Cancer Institute.

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This Is How Celebs Got Ready for the Oscars

Beauty’s biggest night of the year went down on Sunday, February 28, and celebs brought their A game (and then some) to the red carpet. Seriously, so much makeup goodness, we can’t.

Getting Oscars-ready is an all-day adventure, and sitting in hair + makeup for hours could get a little intense if it weren’t for the dawn of social media. Thanks to Instagram, celebs shared behind-the-scenes beauty moments and we’ve rounded up our favorite looks for you to lust over.

RELATED: A Moment to Honor Daisy Ridley’s Oscars Up-Do

This article originally appeared on MIMIchatter.com.

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8 Hair Products Health Editors Always Have in Their Gym Bags

Any workout you can think of, there’s probably a Health editor who loves it—we have staffers training for marathons, crushing CrossFit WODs, flowing through vinyasas, and everything in between. So we have learned a thing or two about what it takes to transition from sweat to street without looking like a hot mess. Here are the post-workout hair products our team swears by.

Nike Central Training Headband ($15; nike.com)

“On Mondays during my lunch break, I like to take an indoor cycling class at the office gym—but I often need to rush back to my desk and don’t have time to wash and blow-dry my hair. This Nike headband has been a lifesaver. It wicks the sweat from my brow and the nape of my neck, minimizing the time I need to make myself look professional again post-workout.” —Christine Mattheis, Deputy Editor

Photo: nike.com

amika Perk Up Dry Shampoo ($24; birchbox.com)

“I originally discovered this dry shampoo in my monthly Birchbox and have been buying it ever since. It does an amazing job of absorbing oil and grease and giving my hair volume. And unlike lots of other dry shampoos, there’s no white residue left behind on my hair (which as a brunette, can be so annoying). The super cute packaging doesn’t hurt either.” —Kathleen Mulpeter, Senior Editor

Photo: birchbox.com

Neutral Tones No-Crease Hair Ties ($10 for a 30-pack; amazon.com)

“I love that these stretchy ties are gentle on hair (no ponytail creases!) and they won’t dig into skin uncomfortably when you’re wearing one on your wrist. And this 30-pack comes in a range of neutral colors, so you’re guaranteed to find one that blends into your hair color.” —Kathleen Mulpeter, Senior Editor

Photo: amazon.com

Bumble and Bumble Don’t Blow It ($31; sephora.com)

“I hate blow-drying my long hair, especially after a workout when I’m already overheated. But I can’t go back to my desk after a lunchtime workout with wet hair all over the place. So my post-shower routine (after I wash with my favorite cleansing conditioner) is to work Don’t Blow It through my hair and twist it into a loose bun with a fabric tie. After a few hours, I take out the bun and let my hair air dry the rest of the way for a loose, messy wave. The product helps keep frizz under control and gives just enough hold.” —Jeannie Kim, Executive Deputy Editor

Photo: sephora.com

Goody Simple Styles Spin Pin ($7; walgreens.com)

“These are those weird twisty-looking bobby pins you probably ignore in the hair aisle at the drugstore, but I urge anyone with a ton of hair to give them a chance. These are amazing both during high-intensity workouts and for afterward when you need to take a giant mane and whip it up into a fast bun. I used them all through my ballet years, too, and just two or three can hold my hair in place while jumping around. I wear them every single time I work out, but I also just redo my bun after, plop these back in and I’m good to go in minutes. (I also personally think they are harder to lose than regular bobby pins. Ha.)” —Jacqueline Andriakos, associate editor

Photo: walgreens.com

Klorane Dry Shampoo with Oat Milk ($20; sephora.com)

“This is the absolute best dry shampoo I have ever found. I have incredibly oily hair and I sweat a ton. But after I spray this, not only is the grease completely gone, my roots have volume and aren’t lifeless and matted to my scalp (which always happens with other dry shampoos for me). In other words, my hair actually looks like I showered and blow-dried it. Plus, they sell it at Sephora in a mini size, so it takes up no room in my bag.” —Jacqueline Andriakos, Associate Editor

Photo: sephora.com

Moroccanoil Treatment ($15; nordstrom.com)

“I keep a little bottle of Moroccan oil in my bag at all times. When I’m done working out, I put a little drop into my palms, run it through my ends and also where my hair tie has creased my hair. It definitely keeps the sweat from drying out my strands and helps to lessen any damage.” —Alison Mango, Editorial Assistant

Photo: nordstrom.com

Pantene Ultimate 10 BB Creme ($7; target.com)

“For the days I’m washing my hair, I like to use products that do double-duty so I can pack less in my bag. This BB cream for your hair actually tackles 10 jobs, including heat protection, taming flyaways, and frizz control. At first, I was scared it would leave my fine hair greasy, but it gets its many jobs done grease-free.” —Dwyer Frame, Contributing Editor

Photo: target.com

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