Are Essure Birth Control Implants Dangerous?
Since the Essure Birth Control System was brought to market in 2002 by Bayer AG, over a million units have been sold and implanted—the majority of the devices are marketed to American women. Essure is an invasive birth control device consisting of two metal coils inserted into the fallopian tubes to prevent unintended pregnancies.
However, the last 15 years have proven that the device is far from perfect, and thousands of women have reported serious injuries and health issues directly related to Essure implants. As of 2016, over 10,000 Essure-related medical device adverse event reports were submitted to the U.S Food and Drug Administration (FDA). In February, 2016, the FDA ordered Bayer to conduct a 7-year study on Essure complications. In the meantime, injuries continue to accumulate and numerous class-action lawsuits have been filed against Bayer and pharmaceutical developers for failing to properly test the medical devices before bringing them to the market.
Essure has been linked to at least four adult deaths, 15 fetal deaths and hundreds of unwanted pregnancies. The FDA has received countless other reports of serious side effects, submitted by physicians and suffering patients. Any patient with an injury due to implantation of an Essure Birth Control System may have a successful claim and can recover mounting medical costs, lost wages, and damages for physical and emotional trauma.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio toxic tort attorney representing plaintiffs nationwide in a wide variety of civil litigation claims against pharmaceutical and medical device companies.
Dangerous Essure Side Effects Reported by Patients & Doctors
The most commonly reported complication of Essure is pain following surgery. In almost 10,000 reports analyzed, pain is mentioned in nearly every one. Making matter worse, sometimes the pain does not subside. Chronic pelvic pain, abdominal bloating, migraine-type headaches and severe fatigue appear to be most common adverse health events reported. Other complications include:
- Weight changes
- Hair loss
- Allergic or hypersensitivity reactions
- Joint or muscle pain
- Nausea and vomiting
- Muscle weakness
- Vaginal bleeding
- Abnormal weight gain
- Abdominal bloating
- Hives and rashes
- Impairments of short-term memory
The Long-Term Risks of Essure Birth Control Implants
Compared to women who have sought alternative, minimally-invasive sterilization operations, women who receive Essure implants are ten times more likely to need a second operation, according to a study published in the British Medical Journal. Other long-term risks to patients reported to the FDA include:
- Unintended pregnancy
- Ovarian cysts
- Chronic abdominal, pelvic or back pain
- Abnormally heavy menstrual periods on a recurring basis
- Perforation of the uterus or fallopian tubes
While scientific evidence shows that Essure is an effective means of sterilization, hundreds of unintended pregnancies have occurred. Some neonatal or pregnancy complications have been reported and the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement. There may also be a risk of pregnancy outside of the uterus (ectopic pregnancy), likely to result in serious complications.
Compensation for Victims of Essure-Related Injuries
Since Essure was introduced in 2002, doctors and patients have reported hundreds of health issues. More recently, Bayer was forced to adhere to new labeling requirements clarifying the potential risks the device poses to women. But in many cases, the damage has already been done. As a result, thousands of injured plaintiffs have filed claims against Bayer. With Essure still on the US market, it is likely more injuries will occur and more lawsuits will subsequently be filed.
If you or a loved one has suffered an injury after implantation of an Essure birth control device, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.