Bayer Faces Essure Lawsuits. Bayer continues to face lawsuits alleging injuries from Essure, it’s female sterilization device. Plaintiffs in the litigation allege that the permanent birth control device caused adverse events such as immune response, allergic sensitivity, chronic pain, device migration and unintended pregnancy. Lawsuits allege that Bayer failed to warn patients or the medical community about these risks. Essure complaints have increased substantially in recent years, ultimately prompting a label update, among other things.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in drug and medical device injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing an Essure lawsuit.
Essure consists of two metal coils inserted into the fallopian tubes. The device, marketed as a non-surgical option for women who no longer want to have children, is designed to permanently prevent pregnancy as scar tissue grows around the coils, blocking sperm from fertilizing the egg. Essure was originally manufactured by Conceptus, which was bought by Bayer a few years ago.
The U.S. Food and Drug Administration (FDA) approved Essure in 2002. From the time of approval until Dec. 31, 2015, the FDA received 9,900 adverse event reports associated with Essure. Since 2013, most reports have been voluntarily submitted by women implanted with the device. According to the FDA website, the most common Essure adverse events reported were: pain/abdominal pain (6989), heavier menses/menstrual irregularities (3210), headache (2990), fatigue (2159), and weight fluctuations (2088). Most complaints reported multiple symptoms, the agency said.
The FDA also listed the following as the most common device problems: patient-device incompatibility (2016) (for example, possible nickel allergy), migration of the device or device component (854), device operating differently than expected (490), device breakage (429), device difficult to remove (280), malposition of the device (199), and device difficult to insert (187).
In response to growing complaints, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee in September 2015. The panel discussed recommendations for adverse events reported among Essure users, including autoimmune response and allergic reaction, persistent pain, device removal, migration, perforation and bleeding.
After hearing testimony from women, physicians and Bayer, the panel of experts concluded that Essure may not be appropriate for certain women, such as those with hypersensitivity or allergy to nickel, chronic pelvic pain, other autoimmune disorders and previous uterine surgery. Patients should fully understand the risks and possibility of adverse events before deciding to undergo Essure implantation, the panel said.
“Maybe some more bolder specific information needs to be given to patients…about autoimmune responses, what it is…a highlighted bulleted piece as opposed to a big long list with lots of information,” said nonvoting panel member Deborah L. Myers, MD, from the Women and Infants Hospital of Rhode Island, Providence, according to Medscape.
Some women told the panel they believe that allergic reactions to Essure caused autoimmune response problems. One panel member, a Harvard dermatologist, said Conceptus should have further investigated the effect of Essure in women with allergies or nickel hypersensitivity. In its recommendations, the panel said the FDA should order Bayer to conduct more studies on how Essure is related to allergic reactions or auto-immune irritations.
Parker Waichman notes that Bayer is facing Essure lawsuits alleging various adverse events, such as autoimmune response.
Essure Clinical Trial Data Altered, Participants Allege
There has been controversy involving Essure, as some users and advocates have called for the device to be removed considering injury reports. Additionally, Essure made headlines regarding clinical trial data used to approve the sterilization device. Some women who participated in the clinical trials allege that their responses to survey questions were not accurately recorded.
In October 2015, NBC New York reported that several Essure clinical trial participants believed their responses were not documented appropriately. The news station’s I-Team first interviewed a participant who complained of the issue in 2013. NBC reports that, as of October 2015, two other women say that investigators did not accurately record their responses to questions about comfort and pain.
In response to the allegations, an FDA spokesman stated to NBC, “The FDA is aware of allegations from women who participated in the original Essure clinical trials that the feedback they provided about the comfort wearing the device was not recorded accurately by clinical staff,”
NBC reviewed case reports of three patients who cited severe pelvic pain, but their comfort level was recorded as either “excellent” or “very good”. Clinical trial data indicates that 99 percent of participants rated the comfort of Essure as good to excellent. Bayer denies allegations of inaccurate reporting.
An assistant professor of obstetrics at Yale, Aileen Gariepy, told NBC she believes that the clinical trial data underestimates the number of injuries associated with Essure after implantation. “This is incredibly concerning that patients who were enrolled in the clinical trials are reporting that they were coached for their answers or that their answers were changed,” she said.
FDA Updates Essure Warning, Patient Checklist
In November 2016, the FDA announced labeling updates for Essure. A boxed warning, also known as a “black box” warning, now discloses reports of implant perforation, device migration, allergic reaction, pain and other potential adverse events.
Some Essure users have complained of perforation, where the coils poke through the fallopian tubes and migrate to a different part of the body. The updated label warns of persistent pain after the procedure, changes in the menstrual cycle, allergic reactions and symptoms similar to autoimmune diseases such as joint pain and fatigue.
Following Essure implantation, common adverse events include pain, cramping, nausea, dizziness and vaginal bleeding.
In addition to the new boxed warning, Essure will also now come with a new patient checklist. This document includes important checkpoints that physicians should review with patients considering Essure, ensuring that they fully understand the risks.
Bayer will be conducting further research into Essure adverse events for the next five or six years. The company will be monitoring 1,400 women implanted with Essure and 1,400 women who underwent laparoscopic surgery for sterilization. The study will compare the rate of adverse events between these two groups, and identify complications such as chronic pelvic pain, heavy bleeding, autoimmune disorders and unplanned pregnancy.
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