Bayer Healthcare’s Essure birth control system may not be as well-known as other forms of birth control, like Yaz, Yasmin and NuvaRing, but based on the number of adverse events that have been reported in connection with Essure in recent years, that may change soon enough. Designed by Bayer to be a permanent form of birth control without having to undergo surgery, Essure has been linked to a risk of devastating side effects in women across the country who have chosen the implant over traditional tubal ligation surgery, including recurring problems like chronic pain, device migration, organ perforation and more. If you believe you have been harmed by possible side effects of Essure, consult a qualified Essure attorney today to discuss your legal options. With an experienced Essure lawyer on your side, you can protect your legal rights and pursue the financial compensation you deserve for your losses.
Approved by the U.S. Food and Drug Administration (FDA) in 2002, Essure is an implantable sterilization device marketed to women as a cheaper, easier and safer form of permanent birth control you can get without undergoing surgery, i.e. a traditional tubal ligation. During the outpatient procedure, two metal coils are placed inside the fallopian tubes, where the device’s polyethylene fibers causes a build-up of scar tissue that, over time, blocks the fallopian tubes and prevents fertilization. Because the Essure implant does not require an abdominal incision or a general anesthetic to be inserted in the fallopian tubes, many women who want to avoid getting pregnant have chosen this method of permanent birth control over others.
When the FDA approved Essure more than a decade ago, the agency granted the device fast-track status through its 510(k) approval process, because it was the only non-surgical sterilization implant on the market and the agency wanted to make it available for consumer use as soon as possible. The FDA’s 510(k) program allows a medical device to enter the market without clinical trials researching its safety and effectiveness, as long as the device is “substantially similar” to another product already on the market. However, critics maintain that Essure’s fast-track approval from the FDA allowed the permanent sterilization device to enter the market without being adequately tested or researched.
According to a growing body of research, women who receive the Essure implant may be significantly more likely to suffer serious complications than women undergoing traditional tubal ligation for permanent sterilization. Some of the most common side effects that have been linked to Bayer’s Essure birth control device in recent years include the following:
Many women who choose Essure over tubal ligation surgery are unaware of the health risks that have been linked to the birth control implant, but the potential for Essure to cause serious side effects in users may not be news to the maker of the sterilization device. According to a citizen’s petition filed with the FDA, an inspector received records of more than 16,000 adverse event reports submitted to the original manufacturer of Essure, Conceptus, between 2011 and 2013, at which point Bayer acquired the company. This means that Bayer may have known about the risk of serious side effects associated with Essure, and chose to withhold this information from consumers and the medical community.
Since Essure first garnered approval from the FDA in 2002, the agency has received more than 5,000 reports of adverse events linked to the controversial birth control implant, including 3,353 reports of chronic abdominal pain, 1,408 reports of irregular periods, 1,383 reports of severe headaches, 966 reports of fatigue, 936 reports of weight fluctuation, and four reports of patient deaths. According to the adverse event reports, one of the patient deaths was tied to perforation of the uterus during device placement, and another was caused by an air embolism during surgery to remove the implant.
One of the most devastating complications from Essure occurs when the implant moves out of position, perforating the fallopian tube, and, in some cases, migrating to other parts of the body, causing serious damage to internal organs and tissues. For women who have suffered device failure, device migration or perforation of the fallopian tube with Essure, it may become necessary to remove the device to resolve the problem. Unfortunately, some women have suffered complications that make it impossible or dangerous to remove the device, and other have required a hysterectomy to resolve the problems.
Also, for women who become pregnant after having the Essure device implanted, which studies have shown happens more often than expected, there may be a higher chance of having an ectopic pregnancy, when fertilization happens outside the uterus, usually in the fallopian tube. Bayer Healthcare may stand behind its Essure permanent sterilization device and market the implant as a safe, affordable and effective way to avoid pregnancy without undergoing surgery, but women across the country who have received the birth control implant have reason to believe otherwise.
Although Essure first entered the market more than ten years ago, consumers and medical professionals are just now being warned that the permanent sterilization device may not be as safe or effective as originally believed. In a study published in the journal Contraception in April 2014, researchers found that 96 out of 1,000 women who receive an Essure implant become pregnant within ten years, a risk that is nearly four times higher than the risk with traditional tubal ligation surgery. The researchers concluded that the risk of pregnancy is higher with Essure (hysteroscopic sterilization) than with tubal ligation surgery (laparoscopic sterilization), because the former is not immediately effective, while the latter is.
Additional studies have examined the potential adverse effects of Essure birth control, and in April 2015, a medical report published in The Journal of Minimally Invasive Gynecology found that the sterilization device increased the risk of complications like chronic pelvic pain, recurring painful and unusually heavy periods, and recurring pain with intercourse. The study followed up 518 Essure participants from a previous study for five full years, and found that, of those participants, 15 underwent hysterectomies, 38% reported unusually heavy menstrual periods on a regular basis, one in 20 experienced recurring pelvic pain, and nearly one in 25 experienced recurring pain during intercourse.
More recently, in October 2015, the British Medical Journal published a study indicating that women who receive Bayer’s Essure birth control implant may face a ten-times increased risk of requiring revision surgery to manage complications, compared to women who undergo traditional tubal ligation surgery. The conclusions of this study were based on an analysis of data involving more than 52,000 women in New York who underwent sterilization procedures from 2005 to 2013. According to the researchers, “A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern.”
In September 2015, the FDA’s Obstetrics and Gynecology advisory panel met to discuss the safety and efficacy of Essure, which at that time had been linked to more than 5,000 adverse events in women. At the FDA panel meeting, more than a dozen women came forward to testify about their experiences with Essure, detailing devastating side effects allegedly caused by the sterilization implant and calling for an Essure recall. Although the FDA decided against issuing an Essure recall at that time, the agency said that it “will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks.”
Earlier in the year, the FDA announced that it would be launching an investigation into the potential for Essure to cause serious side effects in women, including such problems as chronic abdominal pain, headache, fatigue, allergic reactions, weight fluctuations, unintended pregnancy, migration of Essure inserts through the fallopian tubes, heavier periods, and perforation of the uterus or fallopian tubes. In its announcement, the FDA stated that, in addition to complications highlighted in the Essure warning label, “Other reports [of problems with Essure] describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.”
Concerns about the potential side effects of Essure began to emerge several years ago, when dozens of women across the state of Pennsylvania came forward with stories about devastating complications allegedly caused by the permanent birth control device. According to women who have received an Essure implant, the sterilization implant caused them constant pain and serious health issues that required many of them to have the coils removed. For some women, the health problems persisted and eventually required them to undergo a hysterectomy.
The first Essure lawsuit brought against Bayer over complications allegedly caused by its birth control device was filed in July 2014, on behalf of Heather Walsh, a woman whose Essure device migrated out of her fallopian tubes and resulted in five hospitalizations and a hysterectomy, in addition to lingering adhesion and auto-immune disorders. The Essure lawsuit, filed in Philadelphia civil court, accused Bayer of intentionally misleading women about the safety and effectiveness of Essure, and of violating the conditions upon which the device received premarket approval from the FDA.
As more information comes to light about the potential for Essure to cause devastating side effects in women, Bayer faces a growing number of product liability lawsuits and adverse event reports submitted on behalf of women across the country who believe they have been harmed by side effects of Essure. In fact, more than 10,000 women have joined their voices in an “Essure Problems” group on Facebook, started by women (called E-sisters) who have suffered serious complications from the permanent sterilization implant and are rallying against Essure on social media.
Bayer Healthcare has faced significant criticism in recent years, due to problems with its Essure sterilization implant, and even Erin Brockovich, renowned activist and consumer advocate, has taken up the fight against Bayer’s birth control device. Since Essure first entered the market more than a decade ago, approximately 750,000 women have had it implanted as a permanent form of birth control. Unfortunately, many of these women have suffered devastating, irreversible injuries allegedly caused by the Essure implant breaking, misfiring, migrating out of place or puncturing their fallopian tubes. If you have experienced one or more of these complications, and you believe Essure to be the cause, contact an experienced Essure lawyer today for legal help. You may have grounds to file an Essure lawsuit against Bayer Healthcare, in order to seek fair and timely reimbursement for your injuries, medical bills, and pain and suffering.