The Essure Permanent Birth Control System, also known simply as Essure, was approved by the U.S. Food and Drug Administration (FDA) in 2002 and has become a widely popular birth control option for women across the United States.
Originally developed and manufactured by Conceptus, a major medical device manufacturer that was recently acquired by Bayer, the Essure System is made up of two flexible metal coils. The coils are implanted through a non-surgical procedure in which they are inserted into the fallopian tubes, after which scar tissue forms around them. The scar tissue creates a barrier that keeps sperm from reaching the eggs; thus, preventing conception on a permanent basis.
More than half a million women across the United States use Essure; however, as more and more women use this product, more reports of various adverse side effects have surfaced. The Essure lawyers of Abbott Law Group are currently accepting cases and investigating claims on behalf of women who used the Essure System and subsequently developed any adverse side effects.
According to the FDA, there have been a growing number of reports of negative side effects and other adverse events resulting from the use of Essure.
Some of the reported adverse side effects of using Essure include:
In addition, although Essure is meant to be a permanent birth control solution, many women have had surgical procedures to remove the device after suffering severe adverse side effects. Essure has also simply failed to work in several cases, causing unintended pregnancies.
Since its approval of the device in 2002, the FDA has received more than 5,000 reports of adverse events resulting from the use of Essure. As a result of these Essure side effects, many women across the nation are filing Essure lawsuits against Bayer, claiming that the company, along with Conceptus, failed to warn consumers of the health risks of Essure.
As a result of the many safety concerns raised by users of Essure and doctors who have implanted the device, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee in September 2015.
The Advisory Committee meeting was convened to discuss and review the scientific data pertaining to the safety and effectiveness of Essure, hear experts’ opinions on the device’s risks and benefits, and hear the concerns and experiences of women suffering from injuries as a result of Essure’s defects. The Advisory Committee then submitted its feedback and recommendations to the FDA concerning the device.
After reviewing the Advisory Committee’s Essure recommendations, the FDA ordered Bayer to conduct a post-market surveillance study to obtain more information regarding the benefits and risks to consumers using Essure. While there have been many adverse events reported, the FDA stated that it needed more clinical data to better understand any causal relationships between
Essure and the reported side effects compared to women who undergo tubal ligation as an alternative birth control measure. This study will eventually give the FDA more insight into exactly how safe, or dangerous, and effective Essure may be compared to other forms of birth control. Until then, the FDA and consumers will have to rely and make conclusions based on the hundreds of adverse reports coming from patients, doctors, and other healthcare professionals who have used Essure.
In addition to the post-market study, the FDA required Bayer to include a new box warning and Patient Decision Checklist on the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of Essure. The FDA made this decision after the Advisory Committee determined that consumers of Essure were not reliably receiving and understanding appropriate information about the device and the associated risks prior to making a sterilization decision. The Advisory Committee recommended changes to the patient and physician labeling and more aggressive methods to ensure patients are well informed of the risks, and, with this order, the FDA followed the Committee’s recommendation. These FDA-ordered label changes to Essure also indicate that Bayer was not properly warning consumers of the risks involved in using Essure. In the United States, product manufacturers have a duty to warn of any side effects and potential adverse events that could result from the ordinary use of their products. When manufacturers’ conduct fails to satisfy this duty, they can be held liable for any damages that result from its failure to warn. The Essure attorneys of Abbott Law Group are currently reviewing whether Bayer failed in its duty to warn of the risks of using Essure.
In making its new determinations and orders regarding Bayer’s Essure product, the FDA conducted a thorough review of the available information about Essure and the experiences and complaints of patients who have used Essure since the FDA approved it in 2002. The FDA analyzed both patient reports of Essure problems as well as reports submitted from doctors and other healthcare professionals, as well as from Bayer. In its review, the FDA looked a data from November 4, 2002, Essure’s approval date, through December 31, 2015, and found 9,900 medical device reports related to Essure. The most frequently reported patient problems during this period were pain and abdominal pain (6,989 reports), menstrual irregularities (3,210 reports), headache (2,990 reports), fatigue (2,159 reports), and weight fluctuations (2,088 reports). The most frequent device problems reported were patient-device incompatibility (2,016 reports) (for example, possible nickel allergy), migration of the device (854 reports), device operating differently than expected (490 reports), device breakage (429 reports), difficulty in removing the device (280 reports), malposition of the device (199 reports), and difficulty in inserting the device (187 reports). In addition to the hundreds of serious adverse event reports, the FDA received twenty-six reports of death as a result of using Essure. The reports of death related to adult deaths, pregnancy loss, and death of an infant after live birth. Lastly, the FDA received over 600 reports of pregnancies in patients using Essure. The attorneys of Abbott Law Group are currently accepting cases of women who experienced any of the reported adverse events, and are fighting to hold Bayer responsible for the injuries and emotional harm it has caused.
As if the investigation and review of the safety and effectiveness of Essure were not enough, the FDA was also responsible for investigating Bayer as part of a trade complaint regarding allegations of Essure clinical trial misconduct. The Office of Compliance within the Center for Devices and Radiological Health is also in the process of completing its investigation of the trade complaint regarding the allegations, which were initially made in a citizen petition. The main allegation is of clinical trial misconduct, particularly that the medical records of clinical trial participants were altered to reflect more favorable data about participants’ experiences in the Essure clinical trial. The citizen petition also alleged that the sponsor violated the terms of the approval order and violated laws that relate to the manufacturing and marketing of Essure. In its investigation of Bayer’s misconduct, the FDA did identify modifications to the case report forms; however, it found no evidence that Bayer purposefully modified patient responses and medical records to reflect more favorable data for Essure. Regardless, the fact that enough people signed the citizen petition that spurred the FDA’s investigation into this matter tends to show suspicious behavior on Bayer’s part.
The attorneys of Abbott Law Group are currently reviewing claims on behalf of women who used Essure and subsequently developed any of the adverse side effects or events that are listed above. Please contact us today for a free Essure lawsuit consultation to find out if you may be legally entitled to compensation for the past and future medical bills, lost wages, pain and suffering, loss of consortium, and other damages. In addition to possibly receiving compensation for injuries as a result of using Essure, by filing an Essure lawsuit, you can hold Bayer responsible for its wrongful conduct and help prevent something like this from happening in the future. The attorneys of Abbott Law Group have over thirty years of experience trying product liability and personal injury cases, and they know what it takes to go up against a powerful corporation like Bayer. If your case meets the criteria for eligibility to file an Essure lawsuit, our attorneys will fight to obtain the maximum compensation to which you may be legally entitled. Contact us today for a free case evaluation.