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Faulty Data Used for Essure® Approval?

June 10, 2016 · FLEMING | NOLEN | JEZ, L.L.P.

According to a new study conducted by researchers at Northwestern University, some of the high-risk medical devices used in the areas of gynecology and obstetrics may have been approved based on flawed data. The study claims that the United States Food and Drug Administration (FDA) approved numerous health devices over the last 15 years, and that the approval process should use clinical studies more rigorous than required.

The new study used data on 18 devices that the FDA approved between January 2000 and December 2015. This included clinical indications from endometrial ablation, contraception, and fetal monitoring. The results of the study were as follows:

  • Four devices (22%) were approved despite failing to demonstrate efficacy during the clinical trials.
  • Six devices (33%) were approved despite not being required to undergo post-market study.
  • Three devices (17%) were approved and then later withdrawn from market.

According to the study, Essure® — the permanent birth control made available for women — was approved by the FDA after reviewing short-term evidence and later, there was insufficient post-market study to determine ongoing safety. The results of the study are released just in time for lawmakers in Washington who are planning to strengthen the way medical devices are reviewed by the FDA through a new legislation.

In the study, the authors discuss the Essure® device, which has come under scrutiny as of late due to numerous reports of side effects and adverse events. Women have brought forward complaints of serious pain, unintended pregnancy, organ damage, and more. This permanent birth control works as two nickel coils are placed into the woman’s fallopian tubes. Over time, they will begin to cause scar tissue to develop and wrap around the open areas of the coils. This is supposed to permanently prevent reproduction.

At Fleming | Nolen | Jez, L.L.P., we have been approached by women who have been harmed after using Essure®. Some end up with severe pain, others may have to undergo a hysterectomy to remove the device. These are situations that no woman should have to deal with, and they could have been prevented with proper reviews and post-market regulation. If what this report says it true, it could prove to be a valuable resource for the women looking for answers.

The FDA has been urged by numerous sources to take action in regards to the Essure® and its current standing on the market. We have filed numerous Essure® lawsuits and will continue to do so to help the fight in the matter. There have been forums held by the FDA to evaluate the medical device and even a public outcry for the FDA to remove Essure® from market. If the new study is accurate, this could put added pressure on the FDA, as well as Bayer — the manufacturer of Essure® — to take action and remove the device from market. The FDA has a duty to thoroughly and rigorously evaluate any medical device attempting to reach the market, as well as perform post-market studies to ensure the device remains safe for the public. Without proper evidence, these devices should not be approved.

At Fleming | Nolen | Jez, L.L.P., our Essure® attorneys are hopeful that action will be taken by the FDA soon. We have heard from women suffering from side effects associated with this contraceptive device. Don’t allow yourself to be harmed by something that should be considered dangerous. You may have legal rights and our firm is here to discuss them with you. We have been following the case of Essure® for quite some time now and we understand where the process stands, what action is taking place, and what needs to be done to help those who have been wronged by this medical device. Call us today.

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