FDA Warns Women of Potential Risks of Essure

The U.S. Food and Drug Administration (FDA) recently announced that it would take actions to provide women with information about the risks of using Essure, a form of permanent birth control. This form of birth control involves inserting flexible coils through the cervix and vagina into the fallopian tubes. After about three months, scar tissue forms around the coils and makes a barrier in order to prevent conception.

danger-1166553The FDA recognized that there are potential complications related to these types of implantable forms of sterilization and that it should take actions in order to address these risks. These actions include requiring a clinical study to assess the risks and requiring warnings on the product labels. The FDA stated that the actions recognize that “more rigorous research is needed to better understand if certain women are at heightened risk of complications.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring that food and drugs are safe for people to use. The FDA’s position is that while Essure is safe for most women, some women may be at risk for complications. Those complications may include pain, tears, bleeding, and allergic reactions.

Potential Avenues of Recovery

Women who have experienced complications after using Essure or another brand of implantable sterilization may be able to sue the company based on a number of legal theories. Individuals filing lawsuits may be able to seek compensation for medical bills, pain and suffering, permanent disabilities, lost income, and even wrongful death. Potential avenues for recovery include a failure to warn, breach of warranties, and negligence.

Failure to Warn

One possible avenue for recovery in these types of cases is suing the company for its failure to warn. Generally, failure-to-warn cases are based on the idea that the company that manufactured the product has a duty to sufficiently warn consumers of potential risks involved with using the product. This could include failing to warn consumers about the risk of side effects of a medication, for example.

Breach of Express or Implied Warranties

A claim based on a breach of an expressed or implied warranty is based on the theory that the company failed to meet the standards imposed by a product’s warranties. The basic elements for a breach of warranty claim are (1) the existence of a warranty (either express or implied); (2) the failure of the product to comply with the warranty; and (3) a connection between the failure to comply and the plaintiff’s injury. Express warranties can be created by oral or written statements. Implied warranties generally are based on the assumption that goods are “merchantable.”

Have You Used Essure or Another Dangerous Product or Medication?

If you have used Essure or another implantable form of sterilization and suffered side effects, you may be able to sue the manufacturer. The specific avenues of recovery available to you are based on the facts of your specific case and the court that has jurisdiction over your claim. It is important to speak with a products liability attorney as soon as possible to ensure that you know when and where you have to file so that your claim is not barred. The skilled Chicago injury lawyers at Moll Law Group can help you assess your claim and your avenues for relief in order to seek the compensation you deserve. To arrange for a free initial consultation, call us at 312-462-1700 or contact us through our online form.

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