Faulty FDA guidelines caused women to be injured by Essure birth control

Saturday, November 19, 2016 by: Isabelle Z.
Tags: Essure, FDA, birth control

---

(NaturalNews) Women who are looking for ways to avoid unwanted pregnancy are frustrated by the lack of good choices available to them. Hormonal birth control pills have a slew of side effects, condoms are prone to breakage and reduce sensation, and IUDs can cause excessive bleeding or shift into the wrong position.

When the Essure Permanent Birth Control System first came out in 2006, many women felt it was the solution to their problem. With this method, a doctor inserts two metal coils into a woman's fallopian tubes. After a few months, scar tissue grows around the coils, thereby blocking sperm and preventing pregnancy with as much as 99 percent effectiveness.

Unfortunately, this birth control method has failed to live up to its promise of hassle-free permanent birth control. Some of the women who have used Essure have reported persistent pain, reactions to the metal in the coils, uterus perforation and even fetal deaths. For many women, the only solution to the problems caused by Essure is surgical removal via hysterectomy, which is an extreme surgical procedure that entails removing the uterus entirely.

Tens of thousands of women calling on FDA to pull Essure

Thousands of women have expressed regret at having the device inserted, as they must now deal with chronic pain, bleeding and other issues. In fact, the issues are so widespread that more than 30,000 women have formed a group to provide support. The group, known as Essure Problems, is outraged at the way the FDA has handled the situation, blaming its guidelines for their injuries.

Last month, the FDA issued a recommendation that a black box warning be placed on the packaging of Essure. They also recommended that women go over a "patient decision checklist" to help them determine if the system is a good choice for their situation. However, this means very little, because the recommendations are not binding or legally enforceable!

Even if manufacturer Bayer does decide to print the recommended black box warning, many patients won't see it because the device is inserted by their doctor.

The women are horrified by the flippant response of the FDA, particularly in light of the fact that an independent review of the FDA's Essure data discovered that the agency did not report more than 300 fetal deaths that were linked to the device, instead reporting just five deaths. More than 10,000 adverse events beyond the fetal deaths were also uncovered.

Lawmakers unhappy with FDA response

Pennsylvania congressman, Mike Fitzpatrick, has been working to have Congress remove the device from the market. He issued a statement saying that the FDA's recommendations do not go far enough, and he said that if the FDA cannot be relied on to protect women, Congress needs to take action.

Perhaps even more disturbing is the fact that federal law currently protects devices like Essure from claims of liability. While some judges have allowed lawsuits against Bayer to proceed despite the PMA laws, the group would still like to see the dangerous device taken off the market.

While the women originally set out to fight against Essure's manufacturer Bayer, they are now fighting against the FDA as well. A statement by Essure Problems announcing that they were no longer willing to try to work with the FDA said: "What it boils down to is the FDA continuously relies on insufficient and apparently fraudulent clinical trial data, supplied by the manufacturer, that is significantly outdated and inaccurate."

This is far from the first time the FDA has come under fire. The agency is often accused of handling things poorly at best, and being entirely corrupt at worst. Whether it's approving antidepressants in the face of evidence that they cause young people to kill themselves, pushing toxic vaccines, launching regulatory assaults against the CBD industry, or failing to come down hard on Essure and other problematic pharmaceutical offerings, it's clear that the FDA does not have our best interests at heart. That's why it's more important than ever to seek out natural remedies so we don't have to rely on corrupt regulatory agencies.

Sources include:

DrugWatch.com

NaturalNews.com