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The FDA may have approved Essure, but who is liable for damages?

The Food and Drug Administration bears the responsibility of ensuring that food products and consumer drugs are safe. When the FDA overlooks certain problems with products or does not do adequate testing to determine the safety of a product, the public can suffer.

Readers may know there is an ongoing surge of lawsuits filed against the manufacturer of Essure, a type of birth control device. After several reported deaths of women who had the implanted device, there was widespread pressure for the company to pull the product from the market. While the FDA did have an investigation into the claims that the product was dangerous, the product remains on the market, albeit with a warning label.

Who is to blame?

The legal cases involving Essure are complex, and both the manufacturer of the product and the FDA are denying any responsibility in the unfortunate side effects that some women experienced because of this birth control device. The following facts may help you understand more about this potentially dangerous device and its effects on women:

  • The FDA received over 12,000 reports on Essure in 2017 alone.
  • The manufacturer added a warning label on the packaging of the product and additional information for the patient, yet many people believe that these actions were not enough.
  • A majority of the reports on Essure sent in 2017 involved issues when patients removed the devices.

The Commissioner of the FDA stated that the organization was listening to consumers and patients affected by the device, and that they would continue to dedicate their efforts to consumer safety.

There have been several lawsuits filed against Bayer, which is the company that owns Essure. And even though there are many people who believe the FDA also bears responsibility for the widespread issues related to this permanent birth control device, the agency generally has immunity from suit. For the time being, however, the FDA continues to allow the production, marketing and purchase of Essure.

Did you suffer due to Essure?

If you suffered negatively because of the birth control device Essure, you may have the right to bring a civil claim against liable parties. An investigation into your individual case will identify potential possibilities for your situation. 

You do not have to suffer alone, but you can seek the recovery you deserve to appropriately address your financial losses, as well as your pain and suffering.

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Reich & Binstock - Pharmaceutical Injury & Class Action Lawyers

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