Permanent Birth Control Essure Under FDA Review for Reportedly Causing Pain - Depression and Even Death

The US Food and Drug Administration just announced that they will be holding a public meeting of the Obstetrics and Gynecology Devices Panel on September 24th in order to discuss “the safety and effectiveness” of Essure, a permanent birth control device manufactured by Bayer.

“Some women have reported to the FDA that they have experienced pain or other health problems after Essure placement,” the FDA states on their website.  “Problems have also been reported in clinical studies, and they are addressed in the Essure product information (labeling for physicians and patients). Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.”

According to the FDA’s site, the most frequently reported issues include (in order of most complaints) abdominal pain, heavier periods, headache, fatigue and weight fluctuations, with most of the reports listing multiple side effects. Eleven deaths have been reported, yet confirming whether or not the device was the sole reason for these fatalities is difficult.
So what exactly is Essure? The product’s official website promotes this device as being “99 percent effective,” as well as “the only permanent birth control you can get with a non-surgical procedure.”
“Essure is a small spiral device that is placed in a manner similar to an internal tubal ligation,” Sara Gottfried, a gynecologist and author of The Hormone Reset Diet, tells Yahoo Health. “It’s inserted via the cervix and through the uterus into the fallopian tubes to block fertilization.”

She adds that Essure was approved by the FDA back in 2002, “but adverse events, including multiple deaths, have ballooned in the past few years.”
Back in 2013, famous environmental activist Erin Brockovich (yes, from the movie) launched Essure Procedure, an online forum for women to share their personal stories about Essure. “I believe that collectively we are strong voices that can create change and not only help ourselves but educate and share our stories so that we can help others find the help and comfort they need,” she writes on the site’s homepage. “It is a woman’s right to decide for herself if she wants a certain form of birth control but when they are NOT told of the devastating side effects, well that isn’t right.”
Gottfried concurs. “I have not been a fan of Essure because it doesn’t have a long-enough track record of safety and efficacy,” she states. “I feel like women, in general, don’t get the full informed consent they need and deserve to make decisions about contraception, and Essure is the latest example of that failure.”

Head Transplants: Science or Science Fiction?

Russian computer scientist Valery Spiridonov, suffering from Werdnig Hoffman's disease, has volunteered for the world's first head-to-body transplant.

Valery Spiridonov of Russia wants a new body. His body’s muscles are wasting away from a rare disease called Werdnig-Hoffman disorder, which kills most people by age 20.
Dr. Sergio Canavero of Italy is expected to announce at the annual conference of the American Academy of Neurological and Orthopaedic Surgeons (AANOS) in Annapolis, Md., in June that he’ll attempt to give him one.

"We are now at a point when the technical aspects are all feasible," Canavero, who compared the procedure to cutting a banana with a really sharp knife at a TEDx talk, told New Scientist. He has published a few articles, such as this one, in minor journals.
When contacted by Discovery News, Canavero said he was not currently talking to the press.
The medical and scientific communities, however, beg to differ. In fact, to attempt such a surgery with today’s technology has so many elements of science fiction it’s hard to say which is the most ludicrous: Is it the fact of the 20 or so face transplants done so far, almost all the patients have suffered at least one bout of rejection requiring hospitalization, and one has died? That reattaching the spinal cord is akin to reattaching a bundle of hair that’s been sliced in half, and expecting each individual hair to reconnect with its original half? Or that the brain cannot tolerate more than four minutes without oxygen?
When Dr. Gordon Lee, Director of Microsurgery at Stanford Health Care, first heard of Canavero’s proposal, he figured it stemmed from an Onion article. But he and other open-minded neurosurgeons give Canavero credit for dreaming, and are willing to speculate about whether the surgery will one day be feasible.

“I’m a very open person to new ideas; I would love to be able to talk to him,” Lee said. “But there are some things that are more … far-fetched … than others.”
Before the surgery could move from Star Trek to real life, several things would have to happen. For example, surgeons have been doing various transplants for over 100 years and still have not completely solved the problem of organ rejection.
Of the 100 or so hand transplants that have been performed worldwide, Lee said, there have been a “tremendous number of complications,” and some have had amputations.

Spinal cord injuries continue to frustrate leading doctors in the field. The spinal cord regenerates at a rate of 1 millimeter a day, Lee points out. “So if you take a rule and measure from your neck to your hands, it would take years before body parts would begin to function.” That is, IF it were possible to fuse the spinal cord, and IF the body didn’t reject the head.
Assuming the issues of transplant rejection and regenerating the spinal cord could be solved, protocol calls for perfecting the surgery in much simpler animals first.

Canavero points to the 1970 transplant of a monkey’s head, but that surgery resulted in a monkey that lived, paralyzed, for nine days before its immune system rejected the head. There was no attempt to join the spinal cords. Amphibians have an easier time regrowing the spinal cord, but it’s much trickier in mammals.

“You can’t stick the ends together and expect them to work,” said Dr. Peter Nakaji, a neurosurgeon at the Barrow Neurological Institute in Phoenix. “Imagine taking a bundle of hair and then attempting to squash it back together to find the original hair it came from. Even if they could, the chance of them hooking up in the right places is not just 1 in a billion, it’s 1 in a zillion billion.”
But is there a time in the future when some machine might be able to stitch or meld the right nerves back together?
“It’s not beyond belief, but it’s not anytime in our lifetime,” Nakaji said. “I’m all in favor of the big dream; that’s how we move forward. I wouldn’t want to be one of the people making fun of the Wright brothers. The time may come when we have the technology to do such things.”
Canavero has also compared the surgery to the first flight.

“I agree with the critics, this first one will be more like Kitty Hawk than a Boeing 747,” Canavero told Motherboard. “Then it will be streamlined, perfected. It’ll be faster, you won’t need 150 persons, it won’t last 36 hours, it’ll be done in a hospital next to your building.”
The motivation is there, Nakaji said.
“Will there be a future in which we could swap people around in bodies?” Nakaji said. “It raises the question of who we are, and some very science fiction-y type questions that we don’t know the answers to. But It’s interesting to think about the other crazy ideas that could happen in the future.”

India asbestos industry thrives despite health warnings

Gripping his inhaler as he struggles to breathe, rake-thin Chinnapan Chinnakannu blames his years spent labouring in one of India's scores of asbestos cement factories for his debilitating illness.
When he first started at the factory in western Gujarat state, Chinnapan said he was given protective clothing "but later they stopped providing us with masks and shoes".
"Initially I suffered from breathlessness, but slowly the frequency increased and reached a point where I could hardly work," said Chinnapan, who was diagnosed with asbestosis, or scarring of the lungs, in 2007.
"Slowly I started losing weight, I couldn't even drink water as it made me vomit immediately," the 64-year-old said in his one-bedroom house on the outskirts of Ahmedabad.
A pariah product in most of the West, blamed for thousands of deaths, asbestos is hugely popular in the developing world -- including in India, where it's a $1.4 billion growing industry.
Nations at a UN meeting in Geneva last month tried to add chrysotile, or white asbestos to a list of dangerous substances subject to export restrictions.
But the move was blocked by leading asbestos exporter Russia and other developing nations, a stance supported by India, one of the world's biggest importers.
Activists and unions say India's government must start to recognise the dangers posed by asbestos, whose fibres doctors worldwide say lodges in the lungs causing cancer and other diseases.
More than 50 nations, including all members of the EU, have banned all forms of asbestos, which the World Health Organization says kills at least 107,000 people annually.

 "The time has come to ban this product outright and India must see that. It's just too dangerous," said hazardous materials activist Gopal Krishna.
New Delhi defended its position in Geneva, saying there was "no proof" India's asbestos factories or their products -- used mainly in low-cost housing -- are unsafe.
"We took a call which looked pro-industry but this was done in the absence of credible data (on the health risks)," Shashi Shekhar, India's top official in charge of hazardous materials and chairman of the Central Pollution Control Board, told AFP.
Shekhar said he has commissioned a study into the possible health effects which would take up to two years to complete.
"The whole world is talking about it (asbestos) in a grave way, and so we have to see whether they are right or wrong."
- Business booming -
In Ahmedabad, business is brisk at a huge warehouse where asbestos wholesaler Mansur Satani has little time to talk of health concerns, other than to say they don't exist.
"This is the peak trading period for the year," Satani said as the phone rang constantly in his office.

The industry and other asbestos supporters say curly-fibred chrysotile is safe, and only other forms with more jagged fibres are dangerous.
More than 50 factories throughout India use white asbestos as an ingredient in mainly cement roofing sheets, wall panels and pipes. More than 400,000 tonnes of asbestos is imported every year to feed the plants.
TK Joshi, director of the Centre for Occupational and Environmental Health in New Delhi's Lok Nayak hospital, warned of huge consequences for the industry's workers.
"It could run into thousands (of sick). And that (figure) could rise exponentially in future as the use of asbestos in the last decade and a half has gone up considerably," Joshi told AFP.
But he said exact figures on those already suffering were unknown because of poor record keeping. Many doctors treating patients were also unaware of the symptoms or did not think to ask about exposure to hazardous materials.
More than 300,000 workers are employed in the factories, while thousands more tradesmen install the products, bought at markets and warehouses like the one in Ahmedabad.
"Many cases go undiagnosed leading to an underestimate of the magnitude of harm."
Joshi said he was concerned about a lack of public awareness of asbestos dangers, and poor enforcement of safety laws.
The industry denied its employees were at risk, saying all precautions were being taken, including using machines to handle bags of asbestos to prevent fibres escaping into the air.
Industry association executive director John Nicodemus also rubbished WHO and ILO research on international asbestos deaths, saying they lacked detail.
"That shows that these figures are meaningless and the health concerns are simply overblown," Nicodemus told AFP in an email.
- Money spent on medicines -
Gujarat Composite, which runs the factory where Chinnapan worked, told AFP it adhered to all government-mandated safety requirements, that none of its staff were sick and it was unaware of Chinnapan's case.
Raghunath Manvar, whose non-profit Occupational Health and Safety Association fights for worker compensation, said about 30 were known to be suffering asbestosis in Gujarat, where some 20 factories were based.
"Besides asbestosis, over 100 people are suffering from mesothelioma which is also due to exposure to asbestos," Manvar added.
After being diagnosed, Chinnapan said he fought a long battle for compensation from the state insurance scheme, and now receives 2,700 rupees a month ($42).
He also has a retirement pension from the factory, but with most of the money spent on medicines, Chinnapan must still work to feed his family, something he finds increasingly difficult as the illness takes hold.
"I did not understand what was happening to me. Now almost all my money is spent on medicines and doctors."

Are All Processed Foods Bad for You

It’s clear that all processed foods are bad for you — or are they? Get to the bottom of this mainstream food mystery. Find out which processed foods you should shun and which you should make a run for.

What Is a Processed Food?
The word “processed” has become synonymous with “bad for you,” but that’s not the whole truth. Technically a processed food is a packaged item that has undergone a method of preservation to help increase shelf life. So boxes of cookies and loaves of white bread are processed, but so are canned protein and dairy products.

Processed Foods to Cut Back On

Sugar
Be on the lookout for the “white stuff.” It’s lurking (in high quantities) in places you wouldn’t expect, like flavored yogurts, pasta sauces and savory snacks.

Frozen Entrees
Whether they are low-calorie options or not, TV dinners and the like are not a healthy choice. Instead of whole foods, you’ll find lots of preservatives, sodium and fillers.

Commercial Baked Goods
Check the ingredient lists on pre-made muffins, cakes and cookies — you’ll find a ton of ingredients you can’t pronounce. The homemade version may be more time-consuming, but it will always have the shorter ingredient list.

Condiments
Many bottled sauces pack a double whammy of salt and sugar. Drench your food in these sauces and the calories pile up quickly.
Processed Foods to Eat More Of

Canned Tuna
Yes, canned foods are processed, but it’s hard to beat this affordable and convenient lean protein.

Milk
To keep milk safe, it is processed by pasteurization, a heat treatment used to kill harmful microorganisms. Don’t skip this important source of nutrients, including protein, calcium and vitamin D.

Cheese
Much like milk, cheese is worth keeping around. It does contain more sodium and fat, so keep portions in check.

Frozen Fruits and Veggies
Freezing is a method of processing, but there’s nothing unhealthy about fruits and veggies that have been packed and chilled at their peak of freshness.

Dana Angelo White, MS, RD, ATC, is a registered dietitian, certified athletic trainer and owner of Dana White Nutrition, Inc., which specializes in culinary and sports nutrition.