If you are a part of the more than 500,000 women in America who opted for the Essure birth control implant as your family planning option, you may know about the negative side effects that have emerged alongside its usage. Marketed since 2002 as an alternative option to tubal ligation surgery (a.k.a. “getting your tubes tied”), Essure is meant to allow scar tissue to form in the Fallopian tubes in order to prevent fertilization.
However, many women experienced extreme negative side effects that inhibited their daily lives as a result of using Essure. At Steinger, Iscoe & Greene, our team of Essure birth control implant injury lawyers is here to help if you are one of the women suffering from these complications.
Essure is a form of permanent birth control for women who do not wish to go under the knife. It is more than a simple birth control method; it’s meant for full sterilization purposes.
Essure is a small coil device that is similar to a spring. Made of stainless steel and nickel titanium, the coil is wrapped in fibers of polyethylene terephthalate (PET). The coil forms a tiny insert that is around 4 cm long.
The coil is inserted into the Fallopian tube right before it enters the uterus, at the narrowest portion. Essure works because of the tissue in the user’s Fallopian tubes reacting to the PET fibers on the implant.
The tissue becomes chronically inflamed because of the presence of Essure, and over three months the scar tissue grows into the device, blocking the Fallopian tubes. This process is meant to hold the implant in place as well as prevent fertilization.
The U.S. Food and Drug Administration (FDA) approved the use of Essure in November of 2002, and since that approval there have been numerous complaints reported. In January of 2018, the agency conducted a review of these grievances.
From November 2002 to December 2017, there were nearly 27,000 complaints regarding the device. The volume of these complaints spiked in 2012, and from 2012 to 2015 Essure complaints increased by 1400%.
The majority of these complaints were related to the extreme side effects of Essure, noted below. 40 of the reports made to the FDA related to fatalities, including 8 adult deaths and 4 deaths of infants after birth.
Aside from adverse health effects, there were close to 2,000 reports of unwanted pregnancies in women who had the implant. 875 of the reported pregnancies were losses, including 327 ectopic pregnancies.
Side effects reported from Essure usage range from simple to severe. The following have been reported by women using Essure:
These extreme effects left many women in severe physical and emotional distress. To remove the device, surgery is required. Some women required hysterectomies or other abdominal surgeries in order to correct the damages Essure caused.
Because of these side effects, women and their families have turned to Essure injury lawyers to help them figure out their best legal options.
In 2016, the FDA instructed Bayer to investigate the risk of Essure to its users. Following this investigation, the FDA issued a black box warning to alert users of the potential side effects. The black box warning is the strongest warning a prescription can have, indicating the medical device can lead to extreme injury and death.
Despite this warning, many women were oblivious to the potential harm of the product. In April 2018, the FDA ordered Essure to only be sold to patients who have reviewed a thorough FDA-approved Patient-Doctor Checklist. The patient must sign the document in order to get Essure implanted.
Essure is manufactured by Bayer, and the company ended the sale of the implant in the U.S. market in July of 2018, to be completed fully by December of 2018. The sales of the implant outside of the U.S. had already been halted.
The company claims that this decision was in response to declining sales, as the black-box warning from the FDA led to a 70% decrease in use of the product. However, it’s more likely accredited to the high level of outrage against the implant from advocacy groups and effected women. Approximately 16,800 plaintiffs have already filed lawsuits against Bayer because of their complications, as of July 2018.
The dangers of the implant has gained the attention of the public as well, with large news outlets such as The New York Times covering the pleas of women suffering due to Essure. In addition, a Netflix documentary was recently released called The Bleeding Edge, which outlines the lenient ways that some medical devices are allowed onto the U.S. market. This film features Essure, and the announcement that sales would be ending came just one week before the film premiered.
If you or someone close to you used Essure and experienced extreme side effects, including but not limited to extreme pain, unintended pregnancy, internal device breakage or migration, or the perforation of internal organs, reach out to us today. Do not let your rights go unprotected.
Contact the Essure injury lawyers at Steinger, Iscoe & Greene to set up a free consultation. We will review the details of your case and figure out the best course of action for your lawsuit. There are no upfront costs; we only get paid if your case is successful. Call us at (800) 916-8108 or contact us online today.