Posted on

“Essure Problems” Seek Congressional Probe into FDA Failure To Recall Essure Birth Control Device

Essure

As thousands visit Essure injury lawyers to explore possibility of product liability lawsuit over Essure side effects, an advocacy group is seeking a Congressional probe into FDA oversight of the birth control device. The 30,000-strong Facebook group “Essure Problems” with hundreds of women who had harrowing tales to tell about Essure side effects has been vocal against the FDA’s failure to recall the contraceptive. It alleges that the FDA did not take into account the many reports of Essure injuries despite “inadequate and inappropriate clinical trials from the beginning.”

In a letter addressed to Jason Chaffet, who heads the Congressional Committee on Oversight and Government Reform, the group highlighted following potential reasons to believe that the FDA oversight of the Essure birth control is not up to the mark.

  • Approval Without Sufficient Clinical Trials

The advocacy group claims that the FDA approved Essure without adequate clinical trials. Only two non-randomized, non-blinded studies were conducted. Of the 926 women selected, 181 dropped out and only a fourth subjects were followed for 2 years. There was no control group, which limited an effective assessment of the Essure side effects.

The post-marketing studies were also surrounded with controversies. According an article published in the New England Journal of Medicine, Essure birth control approval is an example of “lack of thorough examination, no well-conducted premarketing clinical trials, and absence of dedicated follow-up in post-marketing studies.” At least 27 women recruited for trials are now part of Essure Problems and openly discuss how the contraceptive forced them to suffer from complications, including post-placement surgery. There were also no trials to assess the side effects of PET fibers in the Essure coil.

  • No Attention To Essure Side Effect Complaints

The FDA, according to Essure Problems, turned a blind eye to adverse event complaints. Despite 10,000 Essure side effect reports to the regulator and discovery of another 32,000 underreported incidents, it took no action. Making matters worse, the FDA did not comply with the request for a meeting by the advocacy group to discuss Essure injury facts for years.

The group even claims that medical reports of trials were altered and Essure side effect complaints were not acknowledged or reported. In 2016, the FDA admitted an error in reporting the problems associated with the birth control.

  • Delay in Safety Warning

Despite thousands of Essure side effect complaints, the FDA delayed in issuing safety warnings. It admitted inaccurate reporting and intentional misrepresentation of safety data, but took no action. Even a November 2015 warning about “dangers of Lubricious Coating Separation” was not extended to Essure contraceptive coil.

Essure Problems also cites the FDA’s failure to rein in “highly aggressive marketing tactics” by the manufacturer making certain claims. The group has also highlighted business relationships between some in the top echelon of the FDA and manufacturers. It even questions the FDA’s failure to recall the birth control device after the February 2016 announcement of a required black box warning and more safety studies saying that such action puts “a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse.”

A study published in the British Medical Journal suggests that Essure side effects put users at a 10-fold risk of surgical treatment compared to laparoscopic sterilization. In the United States, thousands of women affected by complications linked to the contraceptive are considering the filing of a product liability claim.

Contact our Essure injury lawyer or call on 1-800-632-1404 for an evaluation of your product liability claim.

Posted on

FDA Mandates Black Box Warning To Highlight Essure Side Effects

essure attorney

The U.S. Food and Drug Administration, under pressure from activists and women who suffered from Essure side effects, has finally asked manufacturer Bayer to add a “black box warning” to its controversial birth control device. The step was imminent in the face of large number of adverse events reported in print and social media over the years. A joint Essure lawsuit representing two dozen women has also been filed against Bayer for “actively withholding” information on the contraceptive side effects reported to it.

According to the FDA statement posted on its website, the strongest safety warning label on Essure birth control is “to call attention to serious or life-threatening risks.” It also called for additional studies and trials to address Essure safety concerns. Essure was approved in November 2002 as a permanent sterilization option for women. By May 2015, the FDA received over 5,000 Essure side effect complaints highlighting contraceptive failure, migration, unintended pregnancies, abdominal inflammation and pain, uterus and fallopian tube perforation, severe allergic reaction, and miscarriages. Bayer is accused of hiding thousands of post-marketing reports on the birth control adverse events.

Essure device comprises of two nickel-titanium coils with tiny and flexible polyethylene terephthalate inserts. The coil when inserted into the fallopian tubes using a catheter induces scar tissue growth for a three-month period. This ingrowth turns into a barrier inside the fallopian tubes blocking sperm movement. It is a permanent sterilization method and for those who do not want children in the future.

The FDA Essure warning also accompanies a checklist for doctors to ask patients about their experience and provide inputs about safety and effectiveness of the birth control device. Planed to have a sample of size of at least 2,000, the assessment will go on for three years.

Earlier in July 2015, the FDA went for a review of the birth control. However, it ended with the manufacturer being asked to carry on more safety research. Consumer groups and activists are critical of such FDA action and have been demanding a recall of the birth control device. Bayer is also accused of not reporting Essure side effects to the FDA over the years and this could have led to safety assessment years earlier saving thousands of users.

Essure Perforation Lawsuit

A Texas woman has filed an Essure lawsuit claiming that side effects forced her to undergo hysterectomy surgery. She had severe pain, chronic cervical inflammation, and bleeding soon after she had the birth control device. The contraceptive side effects also resulted in fatigue and uneasiness during intercourse and she also developed ovarian cysts, according to the Essure injury lawyer representing her. She had to undergo a total hysterectomy to take out the contraceptive coil.

The Essure lawsuit claims that the plaintiff selected the birth control device, as the manufacturer failed to provide adequate information about potential adverse events linked to the contraceptive. Bayer has been accused of suppressing side effect complaints and misleadingly advertising the birth control coil as a safer sterilization procedure despite post-marketing reports on adverse events.

In February 2016, the FDA acknowledged at least 294 confirmed fetal deaths linked to Essure migration causing unwanted pregnancies. The figures, previously put at 125, were reviewed after the regulator found discrepancies in Bayer’s reporting of Essure adverse events. While thousands have become members of a Facebook group “Essure Problems” to express their anguish over sufferings due to the birth control side effects.

For filing Essure injury lawsuit seeking compensation and damages for complications associated with the Essure birth control device, contact our Essure attorney or call on 1-800-632-1404.