FDA Has Restricted the Sale of Essure Birth Control ImplantsEssure Permanent Birth Control Injuries and Complication Lawsuits

South Carolina defective medical device attorneys fighting for the injured

Essure is a permanent birth control device designed as a less invasive contraceptive option than traditional tubal ligation. Since the product became available, women have suffered debilitating pelvic pain, perforation of their fallopian tubes, bleeding, and other symptoms causing many to undergo surgery to have the Essure device removed.

The South Carolina dangerous medical device attorneys at McGowan, Hood & Felder, LLC, represent clients who have suffered injury from defective medical devices. We are here to obtain justice on your behalf. If you were injured because of Essure or know someone who was, let us help.

What is Essure?

Essure was approved by the U.S. Food and Drug Administration (FDA) in November 2002 as a Class III device through the Pre-Market Approval process (PMA). Essure was originally manufactured by Conceptus, but Bayer acquired it in 2013.

Essure is comprised of two metal coiled springs that are implanted in the fallopian tubes. Over time, scar tissue develops around the implant. The scar tissue is intended to block the opening of the fallopian tubes, thus preventing pregnancy.

What is the problem with Essure birth control?

While implanting the Essure birth control device takes just ten minutes and is usually painless, thousands of women have reported complications after the Essure device has been implanted, such as severe abdominal pain, heavy menstrual cycles, headaches and allergic reactions to the nickel, severe headaches, and depression. Other women reported unintended pregnancies, miscarriages, and stillbirths while the Essure device was implanted.

Steps taken to help protect women

In 2016, the U.S. Food and Drug Administration (FDA) required a “black box” warning for Essure, with safety statements to better communicate to patients and healthcare providers the significant side effects or complications associated with these devices and information about the potential need for removal. Their guidance included a Patient Decision Checklist, which listed the following information that should be addressed with potential users:

  • Notification of the permanent (and if applicable, irreversible) nature of sterilization in general, and the implant more specifically;
  • Recognition of available alternative contraceptive modalities and their safety and effectiveness;
  • Situations in which the device should not be used or implanted (e.g., contraindications);
  • Steps, if any, that need to be followed before the implant can be relied upon for contraception and the importance of compliance with those steps;
  • Information on effectiveness and chances for unintended pregnancy and ectopic pregnancy, including a statement that no contraceptive device is 100% effective;
  • Significant and/or common adverse events, including patient-reported outcomes, which may occur during or immediately following device placement;
  • Clinically significant longer-term adverse events or outcomes that have been reported in clinical trials or via other device use experience – including significant events that may persist from the time of implantation and those that may appear for the first time later after implantation;
  • A brief discussion of the types of signs, symptoms, or events that may represent device-related complications for which the patient should seek prompt evaluation;
  • A disclosure of the device materials and any risks that may be associated with them, including allergy/hypersensitivity and Magnetic Resonance Imaging (MRI) safety information, if applicable; and
  • Information related to device removal and/or reversal (e.g., reasons for removal, techniques, outcomes).

In 2018, the FDA restricted the sale and distribution of Essure birth control. The FDA now requires doctors and healthcare facilities to review the Checklist with their patients, and both the patient and the doctor must sign the form before the device may be implanted. The FDA revised the black box warning to include instructions regarding the patient-doctor checklist and acknowledgement form requirement.

Bayer has stopped selling Essure outside of the United States.

What are some examples of Essure birth control injuries and complications?

Consumer Safety reports that “26,773 complaints about Essure were filed with the FDA from late 2002 through late 2017.” Bayer estimates that there are more than 750,000 women worldwide who have had the device implanted in the 15 years since the device has been available.

Some examples of the types of adverse effects and complications from the Essure birth control device include:

  • Hysterectomy after Essure implantation
  • Device migration
  • Fragmentation of device
  • Perforation of Fallopian tubes, uterus, bowel and other organs
  • Adverse metal allergy reactions
  • Ectopic pregnancy
  • Unintended pregnancy
  • Miscarriage, still birth
  • Bleeding
  • Nausea
  • Cramping
  • Pelvic pain

A research study published in the British Medical Journal (BMJ) found that the Essure birth control device does not provide any more effective contraception for women than a traditional tubal ligation, but it carries a tenfold higher risk of requiring reoperation within a year.

How many women filing Essure birth control lawsuits?

Consumer Safety reports that thousands of women have filed lawsuits against Bayer in federal and state courts. At this time, no class-action or multidistrict litigation (MDL) has been established at either level, though that could change given then number of cases.

How can an Essure birth control injury attorney help your case?

When you work with our South Carolina defective medical device attorneys, you benefit from our decades of experience obtaining justice for countless other clients who have suffered needless injury. We investigate your claim and document your injuries. We leverage our skill and experience to recover compensation for your injuries and losses. Our dangerous medical devices attorneys hold those responsible for your injuries liable for your damages.

Schedule a consultation with a South Carolina firm that will fight for you

The attorneys at McGowan, Hood & Felder, LLC, are here to obtain justice in the form of fair compensation for our clients who have sustained injuries from defective medical devices. We take on tough defective product liability cases in South Carolina and represent people with cases throughout the country. Please call 888.302.7546 and schedule a free case evaluation with a defective medical device attorney or fill out our contact form.

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