The Food and Drug Administration (FDA) recently announced that the number of Essure birth control implant injury reports have risen in the past two years.

Approved in 2002, the Essure birth control implant is manufactured and marketed by Bayer HealthCare and is the first non-surgical sterilization method for women. In late 2015, however, the FDA had analyzed numerous adverse event reports regarding Essure as the agency began to prepare to evaluate the risks and benefits of the product.

The FDA had released a 90 page report in advance of the Obstetrics and Gynecology Devices Panel’s meeting, which discussed the Essure side effects not mentioned on the product’s label.

The Essure birth control implant, while approved by the FDA in 2002, has since received nearly 5,100 injury reports related to complications from the device. In 2011 there had been 115 reports submitted, which increased to 2,260 in 2014.

The most frequently reported Essure side effects include abdominal pain, menstrual problems, and headaches. The panel had also discussed more serious reports of the Essure perforating the uterus and fallopian tubes, which caused numerous side effects like bleeding irregularities, allergic reactions, and pregnancy complications.

When the FDA announced the meeting in June 2015, the agency noted that four deaths had occurred from Essure complications. One of the deaths was reportedly caused by an infection in the area the device implanted, while another death was linked to an embolism during a procedure to remove the Essure coils.

The FDA also indicated that five fetal deaths occurred, from women who had become pregnant despite the birth control implants. However the FDA also noted that these severe injury reports could have been made from inaccurate or unverified information;  it did not ultimately conclude whether or not the device is defective.

Overview of Essure Birth Control Allegations

The Essure is made up of metal and polyester and is implanted by a medical physician through a non-surgical procedure. It is inserted through the vagina and uterus, with each of the coils eventually being placed in each of the fallopian tubes.

Soon after insertion, tissue begins to surround the metal coils, and ultimately blocks conception. Upon its release in 2002, Essure was considered a breakthrough in the field of contraception for women who no longer wanted to be fertile as it was boasted to be safer than traditional tubal ligation. Unfortunately there have been a number of women who allege that they suffered severe Essure side effects and have filed Essure lawsuits.

In February 2015, a law firm in Florida had filed a citizen petition that called for the Essure to be recalled from the market. The petition claimed that the Essure clinical trial records had been manipulated or falsified in order to earn FDA approval for release in 2002.

At this time manufacturing company Bayer is still reviewing the petition and has issued the statement that the company “is committed to patient safety, and it is our top priority at the company.”

Women who have suffered injuries from the Essure birth control implant may be eligible to file legal action against Bayer.