Tamara Burns  |  June 29, 2016

Category: Legal News

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Essure LawsuitA recent Essure study has claimed that the U.S. Federal Drug Administration has relied on faulty data to approve a number of medical devices since 2000, including the Essure permanent contraceptive.

The Essure study appeared in the June 2016 publication of Obstetrics and Gynecology and is entitled “Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.”

“Recent controversies surrounding obstetrics and gynecology devices” including the Essure permanent birth control device, “highlight the need for deeper understanding of obstetrics and gynecology medical device regulation,” the Essure study authors from Northwestern University stated.

They continued, stating, “Our results reveal significant weaknesses in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices.”

The Essure study names 18 devices that have been approved by the FDA from 2000 until last year.

Essure Study Claims Medical Devices Were Not Tested Adequately

According to the researchers, the Essure study shows that the approval of the contraceptive device and other medical devices used within obstetrics and gynecology was based on insufficient studies conducted both before and after the approval of such devices.

Essure was given FDA approval in 2002. The device consists of a metal coil that is placed during an outpatient procedure into a woman’s fallopian tubes.

Tissue naturally begins to grow around the tubes, creating scar tissue and forming a physical barrier that does not allow eggs to be released into a woman’s womb to be fertilized.

Thousands of women have filed complaints prior to this Essure study, saying that they developed severe Essure side effects.

The Essure complications women have reported include headaches, irregular periods, rashes, itching, severe pelvic pain, hemorrhage, depression, fatigue, weight gain, device migration into the abdomen, puncture of the fallopian tubes or uterus, ectopic pregnancy and unplanned pregnancies.

These have caused severe complications to the fetus and mother and in some cases, even death.

The Essure study says that of the 18 devices that were reviewed, one third of them were not required to conduct post-market studies to look at the ongoing safety of the devices.

Four of the devices, nearly a quarter of those studied, gained approval even though they failed to demonstrate their effectiveness when the clinical trials were conducted.

Another three devices were withdrawn from the market and of those three, none were referred to or recommended for review by the FDA’s obstetrics and gynecology advisory committee.

The authors of the Essure study also raised concerns over the “21st Century Cures Act,” which allows for reduced medical device regulation to allegedly improve access to care by shortening the approval process for certain devices and pharmaceuticals.

The legislation passed in the House and is now awaiting consideration in the Senate.

“There are provisions that would broaden the definition of the ‘valid scientific evidence’ manufacturers need in order to provide medical benefit, said one of the study’s authors. “Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective.”

The FDA held a meeting last September to discuss concerns regarding Essure complications. The agency stated that as of the end of May 2015, over 5,000 adverse events were reported citing various Essure side effects.

As a result of the meeting, the FDA ordered Essure manufacturer Bayer to conduct a post-market surveillance study to obtain more data about the products risks and benefits.

It also required the manufacturer to include a boxed warning and Patient Decision Checklist to be added to the product label.

Many consumers, however, have taken issue with manufacturers doing their own pre-and post-market safety studies, saying that the data is biased when it is conducted by those involved in the making of a product.

In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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If you or a loved one were injured by Essure birth control complications, you may have a legal claim. See if you qualify to pursue compensation and join a free Essure class action lawsuit investigation by submitting your information for a free case evaluation.

An attorney will contact you if you qualify to discuss the details of your potential case.

Please Note: If you want to participate in this investigation, it is imperative that you reply to the law firm if they call or email you. Failing to do so may result in you not getting signed up as a client, if you qualify, or getting you dropped as a client.

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