Paul Tassin  |  January 20, 2017

Category: Legal News

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EssureThe fight continues over Essure birth control implants, as care providers and patient advocates debate the merits of keeping the devices on the market.

Essure birth control implants work by blocking the fallopian tubes from the inside. The implants are designed to be placed inside the fallopian tubes, where over the course of a few months they stimulate the growth of new tissue that eventually occludes the fallopian tubes, preventing sperm from making contact with eggs.

Essure entered the market in 2002 after earning approval by the FDA. Since that time, thousands of patients have come forward complaining about complications they say are far beyond what they were led to expect when they decided to be implanted with Essure birth control implants.

In some women, Essure implants have moved out of position, punctured the fallopian tube, or migrated elsewhere within the abdomen. Others report metal allergies that could be related to the implants’ nickel content.

Women suffering from Essure complications have reported a wide range of symptoms including headaches, abnormal menstruation and intolerable abdominal pain.

By the close of 2015, the FDA had received over 10,000 adverse event reports of complications blamed on Essure.

FDA Lets Essure Birth Control Implants Stay on the Market

The FDA took up the issue a couple years ago, initiating a review of these after-market reports. The agency solicited testimony from a number of women who strongly urged the agency to take the product off the market.

This past year, the agency decided otherwise. Instead of taking Essure off the market, the FDA mandated a new black box warning to be included on Essure’s labeling.

The agency also took the novel step of drafting a three-page checklist listing possible Essure problems to be included with each set of Essure implants. The FDA intends for doctors to review and sign the checklist with their patients before they agree to undergo the Essure procedure.

Critics point out that while the FDA can require label changes and a new checklist, it can’t force doctors to use them. Some doctors have said they consider the checklist intrusive and an administrative burden that might discourage some doctors from using Essure birth control implants.

Planned Parenthood has stated publicly that while it will continue to review the risks and benefits of Essure with patients, it will not ask patients to sign the patient checklist.

Critics also take issue with the FDA’s decision to allow Essure to remain on the market. Reportedly, organizations including Planned Parenthood and the American Congress of Obstetricians and Gynecologists support keeping Essure on the market.

A representative of the ACOG told The New York Times that while there are clearly complications that can occur with Essure birth control implants, there’s not good enough data to determine the magnitude of the problem.

Critics say those organizations’ support of Essure could boil down to money. They claim an Essure procedure nets more revenue for a provider than does more traditional laparoscopic tubal ligation.

Compelling patients to review the negative information in the new warning and checklist could encourage patients to opt for a less profitable procedure, they claim.

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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Join a Free Essure Class Action Lawsuit Investigation

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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Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.