Bayer HealthCare is facing dozens of lawsuits filed by women concerning serious Essure system side effects. Essure was approved by the U.S. Food and Drug Administration (FDA) in 2002 and was advertised as a safe and effective method of permanent birth control.
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, so it is a non-surgical procedure. 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. This is a process that may take three months, reports the New York Times. During that three-month period, an additional form of birth control should be used to avoid pregnancy.
Conceptus Inc. began the development of Essure in 1998. The Essure system failure lawsuit alleges that during that time, when Conceptus began marketing Essure, the company was hundreds of millions in debt. Plaintiffs maintain that debt impacted how aggressively Conceptus marketed its product.
The Essure lawsuit alleges, the hundreds of thousands of American women undergoing procedures such as Essure each year presented an invaluable business opportunity that could aid in pulling Conceptus out of debt. At the time that Essure entered the market, it was the sole product put out by Conceptus, and was subsequently responsible for the way the company approached its debt problem.
In order to promote the perceived safety of Essure and get public acceptance, Conceptus Inc. implemented a plan to allegedly defraud physicians and patients, by means of false advertising and concealment of material facts, according to plaintiffs.
Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered from complications as a result of Essure implantation.
Essure Adverse Side Effects
Bayer HealthCare has steadily marketed Essure as a safer, simpler, and more effective form of permanent birth control than other contraceptive methods currently available to women, plaintiffs claim. However, the Essure lawsuit maintains that Conceptus and Bayer were aware of the serious dangers associated with Essure and the companies allegedly did not provide an adequate amount of safety information pertinent to the system’s risks.
Essure side effects lawsuits allege numerous serious Essure complications that include, but are not limited to: device migration, abdominal pain, pelvic pain, back pain, bloating, weight gain, heavy menstrual bleeding, irregular menstrual cycles, 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.
Essure Legal Issues
The dozens of plaintiffs involved in this Essure lawsuit are from across the United States, from California to Pennsylvania. Had they been sufficiently informed of Essure’s potential complications, they would never have agreed to be implanted with an Essure birth control device and would thereby have totally avoided these risks, according to their lawsuit.
In December 2016, a lawsuit emerged involving a woman alleging that Essure had caused her to suffer severe complications. The woman had the Essure permanent birth control implanted on October 15, 2010, after reviewing different birth control options with her doctor. The plaintiff alleges that Bayer had improperly promoted the permanent contraceptive method without giving adequate information concerning possible complications associated with the device.
Essure birth control is the only non-surgical permanent female sterilization method available in the United States, with Bayer promoting it as a safer and more convenient alternative to tubal ligation (having tubes tied).
The plaintiff had the Essure device implanted by a medical professional, and said she experienced some complications during the procedure. The plaintiff had suffered heavy bleeding, severe pain, and required an adrenaline shot after fainting following the implantation.
The plaintiff alleges that she and her physician had depended on the information provided by Bayer HealthCare when making the decision to use the Essure birth control method.
The plaintiff was previously diagnosed with hypersensitivity to nickel, and would have chosen a different contraceptive method if she had been aware of Essure’s nickel amount. Due to the plaintiff’s nickel allergy, she experienced a number of Essure adverse side effects including: chronic pelvic pain, multiple fibroids, and nickel poisoning.
These adverse side effects brought on by the Essure device forced the plaintiff to have the device removed on September 8, 2015. She continues to suffer from complications. The plaintiff is filing legal action against Bayer HealthCare for neglecting to adequately warn her against Essure side effects. She is seeking damages for multiple counts of negligence and failure to warn, stating she would never have used the Essure birth control if she had been aware of the device’s nickel content.
Legal Advice and Information Involving Essure
Parker Waichman LLP has had years of experience representing clients in numerous medical device injury lawsuits. The firm offers free, no-obligation case evaluations to anyone with questions about filing a lawsuit concerning Essure or any medical device. We urge you to contact us at 1-800-YOURLAWYER (1-800-1968-7529).