Essure Lawsuit Filed After Severe Pain, Complications Resulted in Need for Hysterectomy

According to allegations raised in a recently filed product liability lawsuit against Bayer, complications from an Essure birth control implant caused an Arizona woman to suffer excruciating pain that ultimately led to the need for a total hysterectomy. 

Christine Barreiros filed the complaint (PDF) last month in the U.S. District Court for the Northern District of California, indicating that Bayer failed to adequately warn her and other women about the risks associated with Essure sterilization procedures.

The lawsuit also claims that the manufacturer failed to properly notify the FDA of reports involving Essure problems where the device migrated out of position or caused a multitude of different problems for women throughout the U.S.

Barreiros indicates that she had Essure coils implanted in both her fallopian tubes on July 30, 2013, to provide long-term protection against pregnancy. Soon after, she began experiencing constant and severe ovarian and pelvic pain, migraines, pain during intercourse, heavy bleeding, as well as emotional pain and mental anguish.

Not knowing the cause, she underwent a total hysterectomy, leaving her permanently sterile. The lawsuit indicates that it was not until she conducted internet research in 2015, that she discovered that other women who received an Essure implant has suffered the same problems.

The case joins a growing number of Essure lawsuits filed in recent months, alleging 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.

“Most egregiously, Defendant was not only actively and fraudulently concealing adverse reports of migrations and perforations from Plaintiff, but also from the FDA,” the lawsuit states. “This active concealment is not mere allegation, but evidenced by FDA findings and its citations to Defendant for failing to report eight (8) perforations.”

Essure Birth Control Safety Concerns

Essure is a form of birth control implant offered as an outpatient procedure by many medical facilities to provide permanent protection against pregnancy.

During the Essure procedure, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

In recent years, there have been growing concerns about the safety of Essure implants, with thousands of women reporting severe complications after receiving the device.

Between the date the birth control product was approved in November 2002 and May 31, 2015, the FDA has received at least 5,093 adverse events involving Essure complications.

The Barreiros lawsuit notes that the FDA and the Department of Health issued citations against Bayer for failing to report and actively concealing eight incidents of Essure perforating women’s organs, erroneously using non-conforming material in the implants, failing to use pre-sterile and post-sterile cages, using an unlicensed facility to manufacture Essure coils, and doing so for three years without a license.

She is seeking both compensatory and punitive damages for manufacturing and design defects, negligence, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, and fraud by concealment.