Essure Coils Lawsuit Filed Over Controversial Sterilization Procedure

According to allegations raised in a recently filed product liability lawsuit, complications from Essure coils implanted for permanent sterilization caused a Texas woman to experience severe pain, bleeding and possibly an ovarian cyst, resulting in the need for a total hysterectomy to remove the device.

The complaint (PDF) was filed last week by Alba Sanchez in the California Superior Court in Santa Clara, alleging that Bayer failed to adequately warn women and the medical community about the risks associated with Essure sterilization procedures.

Essure is a permanent form of birth control, which is offered as an outpatient procedure where the doctor inserts bendable coils into the fallopian tubes. This process causes scar tissue to form around the coils over several months, which is supposed to block the tubes and prevent pregnancy.

Sanchez indicates that she had Essure coils implanted in August 2013, and almost immediately began experiencing symptoms of pelvic pain, bleeding, fatigue, dizziness, discomfort during sex, chronic cervical inflammation, vitamin D deficiency and other complications.

Evaluation by her physicians confirmed that the Essure coils were properly in place, but at one point there appeared to be an ovarian cyst developing. It disappeared, but the symptoms remained until Sanchez underwent a total hysterectomy in September 2014.

The case joins a growing number of Essure coils lawsuits filed in recent months in courts throughout the U.S., alleging that Bayer misleadingly advertised the birth control sterilization procedure as safe and effective, failing to disclose the large number of adverse events and complications experienced by women throughout the U.S.

Sanchez claims that Bayer hid the side effects of Essure from women to the point that there was no reasonable way she could have known about the potential risks until she came across an online forum comprised of other women who had suffered Essure problems in April 2014.

“Despite the fact that evidence existed that the use of Essure was dangerous and likely to place users at serious risk to their health, Defendants failed to disclose and warn of the health hazards and risks associated with Essure,” the complaint filed by Sanchez states. “Instead, Defendants marketed, advertised, and promoted Essure while failing to monitor, warn, or otherwise ensure the safety of its users in violation of California state law and FDA regulations.”

The lawsuit states that Bayer failed to report serious adverse events and failed to comply with both FDA and California regulations.

Essure Sterilization Procedure Complications

Sanchez and other plaintiffs pursuing cases in courts throughout the U.S. raise similar allegations that Bayer aggressively marketed the device to physicians without providing the proper training, and withheld information about the risk of Essure complications from the FDA, doctors and women.

Between the date the sterilization procedure was approved by the FDA in November 2002, and May 31, 2015, the FDA received more than 5,000 adverse event reports involving Essure sterilization procedure problems suffered by women nationwide.

Amid growing concerns about the potential Essure procedure risks, including allergic reactions, the device migrating out of position, perforating the fallopian tubes or causing other problems, the FDA held advisory panel meetings last year to review the safety of the device and whether an Essure recall should be issued to protect women.

On February 29, the FDA announced that the device will remain on the market, but stronger Essure warnings will be placed in a prominent boxed warning on the label, to make sure women are informed about the potential risks.

The federal regulatory agency is also requiring Bayer to conduct additional studies to better understand the safety of the birth control coils, which many plaintiffs in the recently filed lawsuits allege should have been performed before the sterilization procedure was ever marketed to women and physicians.

Sanchez presents claims of breach of warranty, negligent misrepresentation, fraudulent concealment, intentional deceit, inadequate warnings, manufacturing a defective product, negligent failure to warn, negligence, and violation of California business and professions laws.