Sunday, October 18, 2015

Birth Control Device Hazardous: Gov't Wrong Again

In 2002, the federal FDA approved Essure, a device consisting of metal coils and other synthetic materials designed to be permanently implanted into the fallopian tubes of healthy women in order to sterilize them.  After years of negative health effects by thousands of women, the FDA is reconsidering the safety of this device produced by Bayer Healthcare Pharmaceuticals, Inc.
"This is a high priority issue for the agency.  The FDA plans to review the findings of this study, along with the latest medical literature on the Essure device . . ."
-- Food and Drug Administration (FDA) statement
For background, click headlines below to read previous articles:

Birth Control Pill Causes Breast Cancer, Vasectomies Cause Prostate Cancer

Contraceptive Pill 'Yaz' Causes Disease, Death

Federal Government Says Pill is Dangerous, but Keep Taking it

'The Pill' Reaches Age 50, but Do the Women Who Use It?

Fictional 'Safe Sex' - Government Losing War on STDs

Pediatricians Push IUDs & Implants on Teen Girls

Also read President Obama's CDC Wants More Worry-free Sex for Teen Girls (fewer pregnancies), but admit Government Failure: Carefree Sex is NOT Possible

On the other hand, studies show that Women Who Give Birth Live Longer and Healthier.

-- From "Essure Sterilization Device Causes 'Serious Safety Concern': Study" by Maggie Fox, NBC News 10/14/15

Dr. Art Sedrakyan of Weill Cornell Medicine in New York and colleagues analyzed data from 8,048 women who got Essure implants and compared them to 44,278 who had standard surgery to block or "tie" their fallopian tubes between 2005 and 2013 in New York State.

"A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern," the team wrote in their report.

"And that surgery is likely to be much more complicated than the laproscopic approach that they should be considering."

The FDA is not considering pulling the device off the market, but will determine whether extra warnings should be added.

To read the entire article above, CLICK HERE.

From "Essure sterilization method under fire" by Elizabeth Cohen, Senior Medical Correspondent, CNN 9/27/15

From November 2002 through May 2015, more than 5,000 women complained to the Food and Drug Administration about the sterilization device, saying it caused problems including unintended pregnancies, stillbirths and debilitating pain and bleeding. On Thursday, the FDA held an all-day hearing on Essure, taking testimony from patients and experts, and promising to announce next steps in the near future.

. . . [Kristiana] Burrell, who also has three stepchildren, said she became pregnant while using the Essure device, even though at the time she was also using a back-up method of birth control.

That baby, whom she and her husband named Ariel Grace, was born in June, nearly three months early. She never took a breath.

Burrell said her obstetrician blamed Essure for the stillbirth, saying the device's coil ruptured her amniotic sac, causing Burrell to go into labor prematurely. She said she now needs a hysterectomy because the device has perforated her uterus.

To read the entire article above, CLICK HERE.

From "Essure Birth Control Implant and Reoperation Need" by Randy Dotinga, HealthDay Reporter (posted at WebMD) 10/13/15

Sterilization with Essure (called hysteroscopic sterilization) does offer benefits compared to other kinds of procedures, Sedrakyan team said, and it's not clear how many of the reoperations were required due to serious medical problems.

Essure procedures were more expensive (a median of $7,800 compared to $5,100) than surgical procedures, the researchers said. And 30 days after the procedure, the odds of a major medical complication were lower for Essure procedures than for surgery.

However, 2 percent of Essure patients required reoperations later on compared to just 0.2 percent of surgical patients. The difference remained after the researchers adjusted their statistics to account for age and other health problems.

To read the entire article above, CLICK HERE.

From "F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant" by Sabrina Tavernise, New York Times 9/24/15

A panel of experts convened by the Food and Drug Administration excoriated the manufacturer of a contraceptive device for not collecting data that they say could have helped predict risks for women. . . .

Women told of autoimmune problems such as eczema, lupus, celiac disease, of cysts, abscesses and tumors, of severe fatigue and losing control of their bowels, and of odysseys through the health care system in search of diagnoses. Many women have sued the company. The company’s supporters say it is not clear what share of those problems, if any, were caused by the device.

Perhaps most troubling was an account by Gabriella Avina, who said she had taken part in the original clinical trials and had worked for the company, explaining the device to women when it first came on the market. . . . She was found to have celiac disease, a thyroid disorder and myasthenia gravis, illnesses that required multiple hospitalizations, chemotherapy and transfusions.

. . . Bayer continued to stand by the device, saying its safety “is supported by more than a decade of science, with more than 10,000 women studied.” . . . It estimates that a million Essure devices have been distributed around the world, about 60 percent of them in the United States.

To read the entire article above, CLICK HERE.

Also read how public schools across America provide sex training for children, and read how various government entities are being injected into the teenage uterus.

And read how the FDA put Unlimited Plan B Abortion Pills in Stores for Kids

In addition, read how increased use of long-acting contraceptives is causing a trend in America: Fewer Children, More Animals/Pets