Essure Faces Scrutiny due to Added ComplaintsMay 23, 2017
An Essure adverse effects lawsuit has been filed on March 21, 2017 against Bayer HealthCare by a group of 28 women. The plaintiffs maintain that Bayer did not alert them of serious health risks that came to light after Essure began to be sold in the United States.
This lawsuit has originally appeared in the Superior Court of Alameda County, but the defendants claim that it is believed that this case has federal-question jurisdiction and should be tried in federal court instead. The request is to remove the lawsuit from the Superior court to the United States District Court.
Essure Complications Emerge
The plaintiffs allege that they each have suffered Essure adverse effects as a direct result of being implanted with the birth control device. 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. However, the approval was based on studies that examined the cases of less than 1,000 women. At the time of approval, it is alleged that the FDA was not aware that Essure was potentially dangerous.
Since that time, it is claimed that Essure has been the cause of serious health complications including uterus perforation, device migration or fracture, prolonged bleeding, chronic pain, and ectopic pregnancies. These serious Essure adverse effects only came to light after thousands of devices had been implanted in women. In this Essure lawsuit, the plaintiffs believe that Bayer HealthCare became aware of these serious complications and neglected to immediately inform healthcare providers and failed to report this pertinent information to the FDA.
Black Box Warning Added
Even after 16,000 Essure adverse effects complaints emerged, Bayer, allegedly still neglected to notify both the consumers and the medical community of the risks. When the FDA eventually learned about the numerous Essure adverse effects, they called for a black box warning to alert consumers and healthcare providers of the serious potential risks.
A black box warning is meant to alert the consumer to an adverse drug reaction, or undesirable experience associated with the use of a medicine in a patient. Adverse events may range from mild to severe. Serious adverse events are those that may cause disability, are life-threatening, result in hospitalization or death, or are birth defects. Boxed Warning is also commonly referred to as a "black box warning." It is placed on a prescription drug's label and is designed to call attention to serious or life-threatening risks.
The plaintiffs allege that if Bayer had warned their own doctors and themselves about these potential risks, their subsequent health issues may have been avoided. As opposed to warning about serious health problems tied to Essure, the defendants launched an aggressive, nationwide marketing campaign to promote their products, according to the plaintiffs. The women claim this campaign was false and misleading.
The Essure Adverse Effects Lawsuit is in the Superior Court of the State of California, County of Riverside.
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.
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.
These adverse side effects brought on by the Essure device forced a 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 Help 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 (1-800-968-7529).