One in Ten Essure Birth Control Implant Removals May Result in Complications

According to updated information provided by the FDA, 10% of Essure birth control removal procedures may result in complications like device migration, device fracture, perforation of the uterus or fallopian tube or bleeding. Essure is no longer available in the United States, but before it was removed from the market, the female sterilization device was implanted in hundreds of thousands of women, many of whom are now pursuing legal claims against Bayer for serious and potentially life-threatening injuries allegedly caused by Essure. Just last month, Bayer announced that it would pay about $1.6 billion to resolve nearly all of the roughly 39,000 Essure lawsuits filed on behalf of women across the country who allege that the birth control implant caused them to experience painful and debilitating complications. If you or someone you love has suffered serious side effects allegedly associated with Essure, contact us today to find out how we can help.

What is the Problem with Essure?

Essure is an implantable permanent birth control device approved by the FDA in 2002 as a nonsurgical alternative to laparoscopic tubal ligation for female sterilization. Essure was meant to be implanted in the fallopian tubes of women who wanted to avoid pregnancy and the device’s flexible coils were designed to cause scar tissue to form within the fallopian tubes, thus preventing sperm from reaching an egg. For more than 15 years before it was removed from the market, Essure was trusted by hundreds of thousands of women and their doctors to provide permanent pregnancy protection. Unfortunately, many of these women experienced unintended pregnancy and/or painful and debilitating side effects occurring during or after Essure implantation or upon removal of the device, including the following:

• Allergic reaction
• Ectopic pregnancy
• Migration of the device to other parts of the body
• Perforation of the fallopian tube or uterus
• Device fracture or breakage
• The need for surgery to remove the device

Essure Black Box Warning

In 2016, amid thousands of adverse event reports, the FDA required a new black box warning for Essure, meant to make patients aware of the potential for the implant to cause complications like allergic reaction, pain, device migration and perforation. The agency also ordered Bayer to conduct a post-market surveillance study in order to help the FDA better understand the benefits and risks of Essure and the rates of complications including unplanned pregnancy, pelvic pain and the need for surgery to remove the implant. In addition to requiring the black box warning and post-market surveillance study, the FDA also restricted the sale and distribution of Essure to healthcare providers who agreed to review a patient decision checklist with patients and give them the opportunity to sign the checklist before receiving an Essure implant.

Essure Removed from the Market

Amid growing concerns about the safety of Essure, the birth control implant was removed from the market in most countries in 2017, but Bayer continued selling the device in the United States until December 2018, and it was available for implantation until December 2019. Earlier this year, the FDA reported that a search of the agency’s adverse event reporting system turned up more than 47,000 Essure-related reports of complications like device migration, device dislocation, device breakage or fracture, implant failure and difficulty removing the device, occurring between November 4, 2002 and December 31, 2019. There were also 3,829 reports of pregnancies in patients with Essure from 2002 through 2019, including 866 live births and 1,929 pregnancy losses, 481 of which were ectopic pregnancies.

Risks Associated with Essure Removal

Many of the problems allegedly associated with Bayer’s Essure birth control implant are reported to occur during the implant removal process, which usually requires surgery to cut the coils out of the patient’s body. In fact, upon conducting an analysis of the more than 17,000 medical device reports submitted in connection with Essure in 2017 and 2018, the FDA found that 85% of those reports involved the device being removed from a patient. Essure is designed to remain in place permanently, but removal may become necessary if a patient is experiencing persistent pain or a hypersensitivity reaction, which can affect women who are allergic to Essure’s nickel component. According to updated information provided by the FDA this month, 80% of the Essure removal reports cite litigation and the top six reported reasons in the Essure removal reports were:

• Pain – 60%
• Genital hemorrhage – 14%
• Device dislocation/migration/expulsion – 12%
• Perforation – 11%
• Suspected allergy to metals – 4%
• Device breakage – 3%

The FDA also found that 10% of the Essure removal reports involved complications believed to be directly related to the removal of the birth control device. These complications included device breakage, coil migration, uterine or fallopian tube perforation, procedural or post-procedural hemorrhage, and device fragments remaining in the patient after removal. For more information about the potential side effects of Essure, or to find out if you are eligible for compensation through an Essure injury claim, contact Consumer Safety Watch today.