Essure

Many women were introduced to a new family planning implant device known as Essure. The device was an alternative to tubal ligation that was promoted as a safe and effective method for sterilization. Unfortunately, many patients experienced more serious side effects than expected, including organ perforation and death.

Thousands of Essure lawsuits have been filed by patients injured by the medical device. However, thousands more patients still have the device inside their bodies, not knowing when it might break down. If you or a loved one was injured by a defective medical product, contact an Essure birth control device attorney to understand your options.

What Is Essure?

Essure is a female sterilization device developed by Bayer, first used in 2002. The device is a metal coil implanted into each fallopian tube, creating scar tissue to form a barrier. This prevents sperm from reaching and fertilizing an egg. Essure is a permanent sterilization option as an alternative to tubal ligation. Essure is a form of permanent birth control that does not have the side effects of hormonal birth control pills.

During implantation surgery, a doctor uses a hysteroscope camera to see inside the uterus. A catheter is inserted with the flexible Essure coil. The coil is implanted, with the same done into the other fallopian tube.

What Are the Side Effects of Essure?

There are side effects of almost any medication or medical device. Side effects range from minor to severe, including death. Some patients had allergic reactions to the metals, causing pelvic pain. In other patients, the devices were not properly implanted and the flexible coils migrated to other parts of the body.

In 2016, the U.S. Food and Drug Administration (FDA) required Bayer to add a black box warning label to the product, including warnings about perforation, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic reactions.

Essure Warnings and FDA Recall

The FDA reported problems with Essure, including adverse events and product problem reports. Adverse events are reported by doctors and medical professionals. Between 2002 and 2023, the FDA received more than 69,000 medical device reports related to Essure.

More than 90% of medical device reports cited litigation. These were patients who were taking legal action related to their chronic pain, suffering, and injuries. The most commonly reported problems were:

• Abdominal pain
• Heavier menses
• Menstrual irregularities
• Device fragmentation
• Perforation
• Headache
• Fatigues
• Weight fluctuations
• Depression and anxiety
• Hypersensitivity
• Hair loss

How Can Essure Cause Medical Injuries?

Like any medical device, it is a foreign object implanted in the body. Over time, the device can break down, fracture, or move inside the body. Without regular monitoring, the patient will have no idea where the device is located or if it has moved. This can also make medical devices more difficult to surgically remove.

The Essure device has been associated with medical injuries in thousands of patients. Some of the complaints included:

• Incompatibility (including nickel allergies)
• Device migration
• Device breakage or fracture
• Dislodged device
• Operating differently than expected
• Implant failure
• Unintended pregnancy
• Improper positioning
• Difficulty in removal

When Can You File a Defective Medical Device Lawsuit?

Many medications and medical devices have side effects that patients and doctors can discuss ahead of time. However, when medical devices have unknown adverse effects, how are patients supposed to react when they have problems? Defective medical devices are responsible for patient injury, suffering, and even death.

If you are injured because of medical negligence, you can file a medical malpractice claim against the doctor. However, if you are injured by a medical device, the doctor may not be responsible. Instead, patients can file a product liability lawsuit against the device manufacturer.

A defective medical device lawsuit can hold the pharmaceutical company liable for selling a defective product. The manufacturer or distributor is liable because they put a dangerous product on the market. Product defects include:

• Design defects
• Manufacturing defects
• Failure to warn of side effects

Medical experts can testify that the product was defective as designed or manufactured, or that the company didn’t warn users about the risks.

How Can an Essure Defect Attorney Help?

There have been thousands of claims by patients and family members related to this form of birth control. A defective medical device lawsuit can help you recover money for your damages, including:

• Medical bills
• Lost income
• Pain and suffering

If a family member died because of injuries related to Essure, you may be able to recover compensation with a wrongful death lawsuit. Damages in a wrongful death claim include loss of support, burial expenses, and healthcare costs.

To get a case evaluation for your dangerous drug or device claim, talk to an Essure medical device attorney for legal advice.