In 2002 Bayer Healthcare Pharmaceuticals LLC got the FDA’s approval for their product Essure. Marked as the only permanent birth control with a nonsurgical procedure, Essure is an alternative to a woman having a tubal ligation (tubes tied), however, the birth control device has been linked to serious side effects and complications. Studies show that Essure can allow pregnancy and cause abdominal pain, bleeding, vaginal infection and, in severe cases, death.
Initially, Essure was FDA approved and was available in stores all over the U.S. The device was approved based on how well it prevented pregnancy, how safe the procedure to implant the inserts was, and how safe the inserts continued to be for the patient after implantation. Now, the FDA is currently reconsidering their approval after a large number of patients reported that they experienced adverse complications because of Essure.
How Essure Works
Essure is a small, flexible coil insert made from a nickel and titanium alloy. First, a doctor implants tiny inserts into each fallopian tube. The entire process takes 10 minutes and no anesthesia is required. The inserts are soft, designed to conform to each woman’s body shape, and do not contain hormones. Over a three-month period, scar tissue forms around the inserts, creating a barrier that prevents contraception. Bayer asserts that when used properly, Essure is 99% effective.
Essure is meant for women who are certain that they do not want any more children. This form of birth control is not effective for women who have had a recent pelvic infection, have had their tubes tied, have an allergy to contrast dye, have an allergy to nickel, or who are already pregnant before deciding to use Essure.
The health complications are due to the fact that the inserts contain nickel-titanium alloys, a material known to cause allergic reactions. Once the inserts are placed in the body, they release nickel into the tubes and patients who are allergic to nickel may have serious allergic reactions. Symptoms of a reaction include rash, itching, and hives. If you are currently using Essure and are experiencing these symptoms, you may be in danger of facing detrimental side effects. In addition to allergic reactions, Essure can cause other complications, including:
- Pain/Abdominal Pain
- Heavier/ Irregular Menstruation
- Weight Fluctuations
- Device Breakage
- Malposition of the Device
Nickel is a very common allergen and can cause contact dermatitis. Contact dermatitis causes an itchy, red rash. It can also cause dry patches of skin resembling a burn, blisters, and severe itchiness. Although the amounts of nickel released in the fallopian tubes by Essure are minute, the damage caused is severe and painful.
In addition to these side effects, Essure is reported to have caused at least 26 deaths, including four adult deaths, miscarriages, and infants that died shortly after birth. A more recent analysis of Essure adverse events indicates that the device may have caused more than 300 fetal deaths.
Can Essure Be Removed?
For a long time, Essure was believed to be non-reversible. Now, although the process is fairly new, patients can reverse the procedure. Removing Essure coils is a surgical procedure which takes about 30-45 minutes and is conducted under general anesthesia. Openings are made into each fallopian tube and the coils are carefully removed so they remain intact. The openings in the fallopian tubes are then sealed. The entire procedure can cost thousands of dollars. If you underwent the Essure procedure, and you are reversing it in order to have a child, it’s important to know that your chances of pregnancy are not ideal. After Essure removal, your chances are around 35% – 40%.
In response to thousands of complaints from women about Essure, in 2015 the FDA convened a meeting of its Obstetrics and Gynecology Devices Panel. The panel made a number of recommendations, including that certain women—especially those with allergy or hypersensitivity to nickel, chronic pelvic pain, autoimmune disorders, or prior uterine surgery—should not use Essure.
The panel also took Bayer to task for failing to collect data that might have helped predict risks for women. Echoing other experts, panelists pointed out shortcomings in Essure safety studies. In a piece published by the New England Journal of Medicine, doctors point out that pre-marketing approval of Essure was based on nonrandomized, non-blinded studies that lacked a comparison group. Similar problems exist with post-approval studies, say the doctors.
An FDA panel member noted during the meeting, “Although relatively low rates [of adverse events] were reported in many of these publications, significant limitations must be taken into account when reviewing the data.”
A Bayer official told the panel that the company received 15,000 Essure adverse event reports in the United States. Women claiming to be harmed by Essure gave powerful testimony about health problems the device caused them. They reported autoimmune problems, abscesses and tumors, fatigue, severe muscle weakness, loss of bowel control, and other issues.
In February 2016, the FDA ordered Bayer to conduct a new Essure post-marketing safety study “designed to provide important information about the risks of the device in a real-world environment
A number of Essure lawsuits have already been filed against Bayer, and much more is expected. Among other things, lawsuits allege:
- Essure is defective
- Essure is unreasonably dangerous
- Bayer failed to comply with federal safety laws
- Bayer knew about Essure side effects but failed to provide proper warnings
- Bayer insufficiently tested Essure
- Plaintiffs would not have used Essure had they been properly warned about its side effects
Contact Jones Brown Law
Our Jones Brown Law team has experience helping countless victims of defective drugs and devices. We understand each case is different, however, we will help you recover what you are entitled to and we understand what you are going through when you are dealing with a defective drug lawsuit or a defective medical device lawsuit. If you or a loved one implanted the Essure device and feel that it has negatively impacted your health, our attorneys can help.
Our Jones Brown Law team has experience helping countless victims of defective drugs and devices. We understand each case is different, however, we will help you recover what you are entitled to and we understand what you are going through when you are dealing with a defective drug lawsuit or a defective medical device lawsuit. CLICK HERE to take our Jones Brown Defective Medical Device Evaluation to get started with your Essure lawsuit.