For many women who found out about Essure, the first female non-surgical permanent birth control device, it seemed like a fantastic solution to have a simple in-office procedure with little recovery time.
Compared to traditional tubal ligation sterilization surgery or laparoscopic surgery, the option to use Essure seemed like an easy decision, and women could have their own OB/GYN, whom they trusted and felt comfortable with, perform the procedure.
However, what many women who ultimately opted for the device didn’t know was that there were many unintended Essure side effects that they were not aware of, and tens of thousands of women have reported severe personal injury as a result of having the Essure device implanted.
The Essure birth control device is a non-hormonal permanent sterilization solution that consists of two small metal coils made from nickel and polyethylene fibers. These coils are inserted by the assistance of a placement device used by a patient’s obstetrician or gynecologist during an office visit.
The physician inserts the device that allows the coils to secure themselves in the woman’s fallopian tubes. The procedure itself takes about 10 minutes, and women do not have to spend time recovering like they would for surgery.
Once the coils are inserted, they stimulate the body to build an inflammatory response which allows scar tissue formation to surround the device. Eventually, the scar tissue will block the woman’s fallopian tubes entirely. This physical barrier prevents sperm from reaching and fertilizing a woman’s eggs, thereby preventing pregnancy.
After about three months, the woman returns to her physician and a “confirmation test” is performed. The physician makes sure that the device is correctly placed and that a complete barrier exists surrounding the coils.
POTENTIAL ESSURE COMPLICATIONS
The complications reported by Essure patients cover the gamut of a number of chronic and unrelenting symptoms in addition to device failure and further complications related to unintended pregnancies.
Reported side effects of Essure birth control devices include:
- Abdominal pain
- Autoimmune conditions
- Bleeding abnormally
- Cramping in the pelvic or abdominal area
- Death of the patient
- Device migration to a different area
- Ectopic pregnancy
- Fetal death
- Fluid buildup in the blood/hyperkalemia
- Internal organ perforation by the device
- Lightheadedness and dizziness
- Pain in the abdomen, back, leg or arm
- Pain during intercourse
- Painful and heavy periods
- Persistent nausea and/or vomiting
- Severe headaches and migraines
- Unintended pregnancy
- Vaginal infection and discharge
Some women have reported that the side effects are so severe that they can no longer function in a normal capacity and that they have had to quit their jobs, with some being homebound or bedbound as a result of their Essure implantation.
One might assume that if the device is causing problems, a way to solve the problem would simply be to remove the device. However, it is not quite so simple, and many surgeons refuse to perform the surgery because it is so risky.
Some surgeons may choose to do a full hysterectomy, but this procedure comes with complications of its own, such as pelvic organ prolapse, incontinence, development of scar tissue, sexual problems, bowel dysfunction, premature menopause and more.
FDA INVOLVEMENT WITH ESSURE
Following numerous adverse event reports filed by women who developed Essure complications, the FDA met with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to obtain more information about the safety profile of Essure as well as its effectiveness and heard from women who claimed to have suffered Essure complications.
At the time the FDA was reviewing data, four patient deaths, 15 pregnancy losses, and 631 pregnancies were reported by women who currently were implanted with the Essure device.
In September 2016, after a year of collecting data about Essure, the FDA finalized its plan of action to move forward after considering all of the information that was presented during the committee meetings and was received from affected women.
The FDA ordered Bayer, the manufacturer of Essure, to conduct a postmarket surveillance study in order to obtain more information about the risks and benefits associated with the device. The study will continue to review data related to Essure through 2023, with a six-month update released in March of this year, and a one-year update being released later this year.
In addition to ordering the study, the FDA issued a final guidance entitled “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” and a Patient Decision Checklist.
However, critics have raised concerns that patients may never even see the labels of the Essure devices prior to having them implanted, and state that the Patient Decision Checklist is optional for physicians to review with their patients, and not mandatory. With strict time limits to adhere to for office visits, many physicians would likely choose not to review this information with patients, critics claim.
WHAT TO DO IF YOU HAVE SUFFERED AN ESSURE INJURY
If you have suffered Essure injury after having been implanted with the permanent birth control device, you may be entitled to seek legal compensation for your injuries.
It is estimated that thousands of women have already filed lawsuits against Bayer alleging that the birth control device is defectively designed and manufactured and that the manufacturer failed to warn patients and physicians of all the potential side effects. In addition, women filing lawsuits state that they would never have had the device implanted if they were fully informed of all the Essure complications that may have potentially resulted from its implantation.
Women who file Essure lawsuits against Bayer may be able to recover damages related to physical and emotional pain and suffering, loss of economic earnings and may be able to earn punitive damages designed to punish the manufacturer for its alleged wrongdoing.
An Essure attorney is available to provide a free, no-obligation consultation to you to discuss your case and to review the legal options you have available.