Controversial Essure Birth Control Implant Entirely Removed from Market

Bayer’s controversial Essure birth control implant has been completely removed from the market in the United States, a year-long move originally prompted by thousands of reports of injuries and deaths occurring after Essure implantation, and federal regulators indicate that 99% of unused Essure implants distributed before U.S. sales were discontinued in 2018 have been retrieved by the manufacturer. Furthermore, the U.S. Food and Drug Administration (FDA) reports that hundreds of women who received the permanent birth control implant prior to the 2018 recall have been enrolled in a study to evaluate the long-term risk of complications from Essure. If you were implanted with Essure and you have suffered a serious side effect like device migration or perforation of the fallopian tubes, contact a knowledgeable product liability lawyer as soon as possible to discuss the possibility of filing an Essure lawsuit against Bayer.

Potential Side Effects of Essure

Essure is a permanent birth control device implant that was approved by the FDA in 2002 for female sterilization and marketed by Bayer as a safe and effective form of long-term pregnancy prevention. Intended as an alternative to tubal ligation surgery, Essure is a soft, flexible coil designed to be implanted in the fallopian tubes. Over the course of a few months, scar tissue is meant to build up around the implant and keep sperm from reaching the eggs, thereby preventing conception. Essure was designed to remain in place for a lifetime but the device was approved based on short-term safety studies and has since been linked to a number of devastating long-term side effects in women, including the following:

  • Device migration
  • Device expulsion
  • Chronic pain
  • Allergic reactions
  • Vaginal bleeding
  • Perforation of the fallopian tubes
  • Unintended pregnancy
  • Autoimmune disorders
  • Hysterectomy
  • Ectopic pregnancy
  • Wrongful death

Timeline of Essure Regulatory Action

Since approving Essure for sale in the United States in 2002, the FDA has received thousands of reports of side effects associated with the birth control implant, ranging in severity from mild pelvic pain and unintended pregnancy to severe pain, bleeding and death. In November 2016, in response to growing concerns about the potential for Essure to cause serious long-term complications in users, the agency added a black box warning to the Essure label highlighting the serious or life-threatening risks linked to Bayer’s permanent contraceptive device. Two years later, in April 2018, the FDA limited the sale of Essure to “health care providers who agreed to review Bayer’s Patient-Doctor Discussion Checklist with patients, and gave them the opportunity to sign it, before Essure implantation.” Three months later, the agency announced that the birth control device would no longer be sold in the United States as of December 31, 2018.

Essure Postmarket Safety Study

It was more than a year ago that Bayer stopped selling and distributing its Essure implant in the United States and last week the FDA issued an update on the complete removal of Essure from the market. According to the FDA, which worked directly with Bayer to ensure that previously sold but unused Essure birth control implants were returned to the company by the end of 2019, more than 99% of unused devices distributed before December 2018 have been returned to Bayer, with only 10 devices still unaccounted for. Unfortunately, prior to Essure being removed from the market, approximately 750,000 women were implanted with the birth control device and may now be at risk for serious and potentially life-threatening complications.

In addition to retrieving unused Essure implants, Bayer is required to conduct a postmarket surveillance study to evaluate the risk of long-term complications among women implanted with Essure. As part of its postmarket study obligations, Bayer will be monitoring 340 women who were implanted with Essure and comparing their long-term outcomes to 788 women who underwent laparoscopic tubal ligation. “We believe clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation,” the FDA reports. “We will continue to provide updates on our ongoing postmarket evaluation of Essure to the public as new information becomes available.”