Essure Benefits May Not be Worth Health Consequences

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

The popularity of the Essure birth control device was largely due to the convenience of the alternative to traditional tubal ligation. Essure is a relatively fast non-surgical procedure, without general anesthesia, that can be performed in a doctor’s office. This is an easier process, ensures shorter recovery time, and is therefore, more convenient.

Tubal ligation is an outpatient procedure, but the time and cost of taking a day off work, spending two to three hours being administered anesthesia, the surgery itself, and allowing for surgical recovery from anesthesia is a more arduous process when compared to Essure, that takes about ten minutes, with virtually no recovery time.

How Essure Works

The Essure birth control device consists of two small coils made of a polyester-like fiber and a nickel alloy. It is implanted in the fallopian tubes by way of a catheter through the vagina. The coils are designed to induce scar tissue to form that would block the tubes and keep sperm from reaching the eggs, thereby preventing pregnancy.

While the initial process of tubal ligation (or having “tubes tied”) is more extensive, the birth control effect is immediate. When an Essure device is implanted, a secondary form of birth control must be used for three months after the procedure. This allows the gradual buildup of scar tissue that is necessary to secure the coils in place. After three months, dye is inserted and a radiologist checks to confirm whether or not the tubes are blocked, to assure the procedure has been successful.

National law firm Parker Waichman has extensive and successful experience in defective medical device litigation. Attorneys at the firm are available to answer questions for individuals seeking legal information for potential lawsuits.

Essure Complications

The U.S. Food and Drug Administration (FDA) approved Essure in 2002. It was promoted as a safe and effective form of birth control.  Adverse effects or complications that have either shown up in clinical trials or have been reported to the agency include device migration, abdominal pain, pelvic pain, back pain, bloating, weight gain, heavy menstrual bleeding, ectopic pregnancy, perforated organs, and miscarriage.

Migration and organ perforation are two of the most dangerous Essure side effects. If the Essure device migrates from its initial location, it can perforate nearby organs, leading to some potentially life-threatening complications.

There have been reports in which the Essure implants have been lost within the patient’s abdomen, yet, the patient continues to experience serious inflammation and pain. Less serious, nevertheless, troublesome, Essure adverse effects are headache, hair loss, fatigue, depression, muscle weakness, joint or muscle pain.

Nickel Allergy

It is still under review whether some Essure adverse effects are caused by a systemic allergic reaction to nickel. The coils do not produce any hormones, so it is a possibility there is a correlation, but that is yet to be determined.

Dr. Peter Schalock of Harvard Medical School asked questions concerning nickel, a metal that is in the device and is a known allergen. Dr. Schalock asked, “How can we not have data on nickel allergy when you have a device that is 55 percent nickel and 20 percent of women are known to be nickel allergic? Why is there no data on that in your package?”

The company representative said nickel allergies have been noted in the instructions for use since the device was released but argued that many other medical devices are made of nickel and that skin tests for allergies do not accurately predict whether a woman would be allergic to such a device, Rewire News reports.

Essure Lawsuit

A woman was implanted with the Essure device in 2010.  She allegedly suffered heavy bleeding and severe pain, according to her complaint. She fainted following the implantation of the device and was treated with an adrenaline shot. The plaintiff maintains she and her physician opted for Essure based on representations made by the manufacturer, Bayer.

The plaintiff has a known nickel sensitivity, but neither she nor her doctor were aware that Essure contained nickel, according to the complaint. The plaintiff alleges she would have selected a different contraceptive if she had been more fully informed. The lawsuit alleges chronic pelvic pain, nickel poisoning, and multiple fibroids. The plaintiff had the Essure device removed in September 2015. She allegedly continues to suffer from pain and complications. She maintains that Bayer neglected to warn of the side effects of the device.

Legal Advice and Information Regarding Essure

If you or someone you know suffered injuries associated with the Essure birth control device, you may be eligible for compensation. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).