FDA Foot-dragging Protected Bayer While Putting Women's Health at Risk

Essure medical complaints to the FDA didn't make it to the public's attention for over 15 years

Friday, December 14, 2018 - The US Food and Drug Administration (FDA) has recently issued a report stating that "over 15 years - Nov. 4, 2002, when Essure was approved, through December 2017 - it received 26,773 reports of problems, including pain, heavier periods and irregular bleeding, headaches, and fatigue. Patients also reported that the device had become dislodged or had broken. And the agency has received reports of eight adult deaths related to Essure," according to an article on NBC News website. (1)

Such devastating news comes as no surprise to many of the hundreds of thousands of women who have had the device implanted to prevent pregnancy, experienced severe side effects and have now filed Essure birth control lawsuits. What is a shock, however, is how long it took the FDA to act. For over a decade, women who experienced severe physical and psychological complications from the faulty birth control device were told by their gynecologist that their symptoms were "all in their heads" and that Essure could in no way be causing them. The lack of action on behalf of the FDA has resulted in millions of women's health and possibly their lives being put at risk when all that was needed was for Essure women to be listened to and their complaints to be taken seriously in the first place.

Essure women have complained for over a decade that the device either broke into pieces or migrated intact to other organs with the female reproductive system. The most likely place for the metal Essure coil to land is in a woman's uterus. Upon recognizing that a foreign object had entered it, the uterus naturally contracts to expel the invader. These contractions cause severe and constant pain from cramping. In addition, the more the uterus contract, the deeper the sharp metal Essure coil is embedded into the uterine tissue causing lacerations, perforations, and internal bleeding as well as mind-numbing and constant pain. Women report such an Essure malfunction causes pain so great that they have been forced to be bedridden, losing their jobs and also destroying the relationship they had with their children and spouses. When women with the Essure device implanted went to their doctor to describe the pain, they were told that they must be imagining the symptoms.

As it turns out, a great many Essure doctors are on the Bayer payroll and take payments that are technically legal, yet seemingly unethical for activities doctors account for as speaking and teaching engagement and consultation fees. When pressed Essure doctors are unable to show proof that any speaking or teaching engagement ever took place making the fee little more than a bribe to recommend Essure and also to cover for the device's side effects. Certain Essure doctors have received over $100,000 in total for such ethically questionable activities. (2)

In 2018, the FDA finally stepped in to hold Essure doctors accountable for failing to advise their patients of Essure's potentially life-altering side effects. As of May of 2018, doctors were required to explain to their patients and have the patient sign a paper that contained a checklist of Essure's side effects that women had experienced and were reported to the FDA. While many Essure doctors ignored the checklist and implanted Essure anyway, many women got the message and declined the birth control device. Enough women rejected the Essure implant in 2018 that Bayer decided to voluntarily pull Essure from the market worldwide citing the device as no longer being economically viable.

Sources:

(1) https://www.nbcnews.com/health/womens-health/women-sounded-alarm-essure-birth-control-device-now-fda-cracking-n865531

(2) https://edition.cnn.com/2018/07/27/health/essure-bayer-doctor-payments-eprise/index.html

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