Essure® Birth Control System May Have Used Fraud to Get FDA Approval

Over 5,000 women have filed complaints to the FDA regarding extremely painful and at times life-threatening side effects from the permanent birth control system, Essure. Many petitions and consumer complaints point out that Essure’s former and current manufacturers, Conceptus, Inc. and Bayer, received premarket approval (PMA) for the system and as a result cannot be sued for compensation. However, these same petitions also suggest that Bayer and before it, Conceptus, may have committed fraud during clinical trials in order to receive PMA status.

E-Sisters: A Growing Network of Women Harmed by Essure

Essure is marketed as a simple, affordable, and painless method of birth control, but Essure user Sarah Payne would argue otherwise. “It was like a ripping,” she said, “…like someone’s taking your muscles or your insides and trying to pull them apart. It would take me to the floor.” Payne believes that the metal birth control device caused severe inflammation that triggered early menopause.

“It’s not worth it,” said Crystal Plumlee when discussing Essure. Plumlee tried the system and now suffers from fatigue, joint pain, severe headaches, irregular menstruation, and weight gain. She told a local news station, “It might seem easier, but it’s not worth it in the long run.”

Plumlee and Payne’s experiences have been echoed by thousands of other women who call themselves “E-Sisters”. These are women who suffered terrible side effects for years all while being ignored by doctors and corporate manufacturers. Some of these women even lost their jobs after being accused of being hypochondriacs or exaggerating their symptoms. Not until the thousands of complaints were compiled and made public did medical professionals and finally, the FDA, begin to take these complaints seriously.

Some of the harmful effects of Essure are as follows:

  • Severe pelvic and abdominal pain
  • Autoimmune disorders, such as Lupus
  • Widespread, chronic pain
  • Severe rashes
  • Loss of teeth and hair
  • Coil migration, which can pierce internal organs
  • Miscarriages and stillbirths
  • Death

What Is Essure and How Does It Work?

The Essure system is comprised of two nickel-titanium alloy coils that, once implanted, cause scar tissue to build up inside of a woman’s fallopian tubes. As the tissue of the fallopian tubes grow into the metal coils, the tubes are blocked and rendered sterile. Obviously, the device can be very dangerous to women with nickel allergies. Similarly, the coils can move around inside of the body and even cut or pierce soft tissues. Though the method is supposed to be 99.83% effective in the best of cases, several women, like Ellen Hanrahan, have still gotten pregnant despite using the birth control system as directed.

Corporation Manipulated Trial Studies

When applying for PMA status, Essure manufacturer, Conceptus held a clinical trial for the birth control system. Kim Huddleston participated in Essure’s trial and even though she experienced considerable abdominal pain only 3 days after being implanted, the company altered her complaints so as to make Essure look less dangerous.

A petition filed on behalf of hundreds of women harmed by Essure suggests that clinical trial participants had their answers crossed out and changed to minimize the level of pain and adverse side effects experienced. The petition states that “this is not a mere allegation of fraud but fraud supported by sworn testimony of several of the actual clinical trial participants for Essure…”

An advisory panel lead by Diana Zuckerman of the National Center for Health Research (NCHR) found similar cases of fraud. Participants in the clinical trial later reported to Zuckerman that when they clearly marked that yes they had experienced pain or health issues, their answers were changed to “no.” Similarly, when participants tried to offer comments or explanations of the pain they experienced, their writing was physically crossed out.

In response, the FDA has updated its description of Essure, but it hasn’t yet stated if or when it will re-evaluate the product or pull it off the market.

Are You in Pain from Essure?

If you or a loved one have experienced severe side effects and pain from using Essure, you should learn more about your legal options. Contact Sokolove Law for a free and confidential consultation. Billion-dollar corporations should not be able to rob women around the country of their basic well-being and happiness. Find out what options are available to you now.

Author:Sokolove Law Team
Sokolove Law Team

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Last modified: December 28, 2016