Bayer Healthcare’s Essure birth control system may not be as well-known as other more popular forms of birth control, like Yaz and Yasmin, but the risk of side effects from the medical device are equally as alarming. Essure is a permanent sterilization device consisting of small coils that are inserted into the fallopian tubes during a transcervical procedure, and the implant works by promoting the growth of scar tissue in and around the coils, thereby preventing pregnancy. However, an Ohio doctor recently attributed a woman’s death to the Essure birth control system, and other severe side effects like perforation of the fallopian tubes and migration of the device to other parts of the body have been linked to the sterilization device. If you believe you have been harmed by serious side effects of the Essure birth control system, contact a knowledgeable Essure injury lawyer today to explore your possible compensation options.
With increasing concerns about the potential for Essure to cause severe side effects in users, many women are seeking safer alternatives to permanent sterilization, even if it involves undergoing surgery. There are a few possible alternatives to Essure for permanent birth control, including:
Essure is an implantable birth control device manufactured by Bayer Healthcare and marketed by the company as the only form of permanent birth control women can get without undergoing surgery. The device features two nickel-coated coils that are inserted directly into the fallopian tubes, where inflammation caused by the implant’s polyethylene fibers causes a build-up of scar tissue that obstructs the tubes and permanently prevents fertilization. Essure was approved in 2002, through the FDA’s controversial fast-track 510(k) process, which allows certain medical devices to enter the market without clinical trials being conducted, as long as they are “substantially similar” to products already available for consumer use. Unlike other forms of permanent birth control, i.e. tubal ligation, Essure does not require a general anesthetic, nor does it require an abdominal incision, which is why many women have chosen Essure over other birth control methods. However, since the device first entered the market, thousands of women implanted with Essure have suffered serious side effects allegedly caused by the medical device.
Essure has been marketed by Bayer Healthcare as a safe and effective form of permanent birth control without surgery, and the medical device has been available in the United States since it first gained approval from the FDA more than a decade ago. However, serious concerns have been raised in recent years about the safety of the Essure birth control system, and at least one lawsuit has already been brought against Bayer over serious Essure complications. Among the side effects allegedly linked to the Essure birth control system are the following:
The first concerns about the potential risk of Essure side effects were raised in 2013, when thousands of women began to come forward to talk about the “excruciating” pain and serious health issues they suffered after receiving an Essure implant. Although Essure has been aggressively marketed by Bayer as a cheaper, more convenient and safer alternative to a traditional tubal ligation procedure for pregnancy prevention, several thousand women who opted for the Essure birth control system over the years have suffered devastating side effects allegedly caused by the implant, with some requiring a hysterectomy to remove their reproductive organs along with the defective birth control device.
The side effects potentially associated with the Essure birth control implant are so severe that famed consumer advocate Erin Brockovich has stepped forward to raise public awareness about the risk of Essure side effects among women, questioning the premarket approval the device received from the FDA that allowed it to enter the market for consumer use. In most cases, premarket approval protects a manufacturing company from any product liability lawsuits, but several lawsuits filed against Bayer over Essure side effects allege that the company violated the conditions for the premarket approval by “actively concealing” adverse reports from the FDA, thereby rendering the premarket approval invalid and exposing the company to litigation.
2014 – More than 10,000 women rally against Essure on a Facebook page started by victims of alleged Essure side effects, and the administrators of the page travel to Germany to testify before the Bayer stockholders meeting, attracting international attention for their cause.
July 2014 – The very first Essure lawsuit is brought against Bayer in Philadelphia civil court, accusing the company of intentionally misleading consumers and doctors about the potential side effects of the birth control implant.
June 2015 – A federal judge is tasked with deciding whether to allow five lawsuits against medical device maker Conceptus, the original manufacturer of the Essure birth control implant, to continue despite the company’s protected status by the FDA. The complaints allege that Conceptus violated the conditions of its premarket approval and should no longer receive protected status.
September 1, 2015 – A product liability lawsuit is filed against Bayer in the U.S. District Court for the Northern District of California, on behalf of a woman whose right fallopian tube had to be removed due to complications from Essure.
2015 – The FDA launches an investigation into the safety and effectiveness of Essure, after receiving a petition for an Essure recall that alleged fraudulent activity on the part of Conceptus, the original maker of the birth control implant.
May 2015 – A New York Times report indicates that the FDA has received more than 4,000 reports of side effects or complications involving Essure, including reports of severe pelvic and back pain, heavy or prolonged menstrual periods, and coils that punctured the fallopian tubes and caused damage to other organs.
June 2015 – The FDA adds a new page titled “Essure Benefits and Risks” to its website, highlighting the alleged long-term side effects of Essure, including pelvic pain, perforation of the uterus, device migration, unintended pregnancy, and rash and itching associated with a nickel allergy.
September 21, 2015 – The FDA posts a 90-page review of Essure online, warning that post-marketing data regarding the safety and effectiveness of Essure is limited.
September 24, 2015 – The FDA’s Obstetrics and Gynecology Devices Advisory Panel convenes to re-examine the safety and effectiveness of Bayer’s Essure birth control implant. More than 20 women testify at the hearing, calling for an Essure recall, and the panel rules that Essure may not be an appropriate form of birth control for certain women.
February 2016 – The FDA issues a press release announcing that Essure will be required to carry a “black box” warning highlighting the potential for the sterilization implant to migrate out of position and perforate the uterus or fallopian tubes.
April 2014 – The journal Contraception publishes research comparing the effectiveness of Essure versus traditional tubal ligation for pregnancy prevention. According to researchers, 96 out of 1,000 women who receive an Essure implant become pregnant within 10 years, which is nearly four times the risk of pregnancy with tubal ligation.
April 2015 – A medical report highlighting the long-term effects of Essure birth control is published online in The Journal of Minimally Invasive Gynecology, with researchers linking the permanent sterilization device to chronic pelvic pain, recurring pain with intercourse, and recurrent painful and unusually heavy periods after five years.
September 2015 – An editorial published in the New England Journal of Medicine points out that the FDA’s advisory panel meeting comes more than ten years after Essure first entered the market in the United States, raising doubts about the effectiveness of the FDA’s pre-marketing and post-marketing regulations.
Since it first approved Essure for consumer use in November 2002, the FDA has received more than 5,000 adverse event reports associated with the controversial birth control implant, including 3,353 cases of chronic abdominal pain, 1,408 cases of irregular periods, 1,383 cases of severe headaches, 966 cases of fatigue, 936 cases of weight fluctuation, and four deaths, one due to uterine perforation during placement and one due to an air embolism during surgery to remove the device. According to a citizens’ petition filed with the FDA, an inspector was given records of more than 16,000 adverse event reports made to Essure’s original manufacturer, Conceptus, from 2011 to 2013, when Bayer acquired the company, which means Bayer may have known about the risks of Essure from the very beginning. Lawsuits brought against Bayer over alleged Essure side effects in the future will likely include the following allegations:
According to Bayer, approximately 750,000 women have already received an Essure implant for permanent pregnancy prevention, and as more information comes to light about the risk of Essure birth control side effects, many more product liability lawsuits are expected to be filed against Bayer Healthcare in the coming months. If you received an Essure birth control implant in the past, and you have since suffered side effects like migration of the device, chronic pain, unintended pregnancy, or perforation of the fallopian tubes, you may be entitled to financial compensation for your injuries. Our consumer advocates at the Consumer Justice Foundation are dedicated to protecting the rights of consumers harmed by dangerous medical devices, and can help put you in touch with a knowledgeable attorney who has experience handling Essure injury claims.