According to a recent study on Essure birth control, the Essure implant may have been initially approved for use based on insufficient or flawed data.

Essure birth control was approved by the FDA in 2002, but thousands of women have since filed adverse events reports, claiming that the device caused extreme and debilitating side effects.

Essure Birth Control Study

The study was published in the June 2016 edition of medical journal Obstetrics and Gynecology.

Researchers at Northwestern Medicine studied gynecological devices like Essure birth control that have been approved in the last 15 years. These researchers focused on devices that have been linked to high-risk complications that were approved between 2000 and 2015.

Researchers reviewed a total of 18 devices, and discovered that only 11 of these 18 devices had undergone random controlled trials to establish their safety and efficacy.

Only 12 of the 18 were required to undergo post-market surveillance so that manufacturers could determine and assess any complications that may occur with women after the initial approval.

Researchers found that three of the devices were removed from the market altogether after they had been initially approved. Two had never been reviewed by FDA physician experts, and the third had been recommended against being allowed on the U.S. market in the first place.

“We looked at the class of devices with the highest potential risk to patients — the devices that had to go through the most rigorous pre-market approval process,” said one of the study’s senior researchers Dr. Steve Xu. “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

Essure was one of the devices examined in the study. Essure has been controversial in recent years, gaining attention for allegedly causing severe complications.

Essure Birth Control Side Effects

Several serious problems with Essure birth control have been reported through adverse event reports and lawsuits. These side effects include, but are not limited to:

• Bloating
• Rashes
• Allergic reactions
• Excessive bleeding
• Organ perforation
• Pelvic pain
• Miscarriage
• Ectopic pregnancy

Essure Birth Control Lawsuits

The  manufacturer of Essure birth control, Bayer Healthcare, is now facing a steadily rising number of Essure lawsuits alleging that research and testing on the devices was insufficient to determine the safety and efficacy.

Lawsuits also allege that the manufacturer failed to adequately warn the public and the medical community about the serious risks linked with Essure birth control.

According to Xu, pre-approval testing standards for devices like Essure birth control may not be high enough.

“There are much higher standards for the approval of new drugs, whether oral, injectable or even topical. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?” said Xu.

If you or someone you love has experienced severe Essure complications after being implanted with an Essure birth control device, you may be able to file an Essure birth control lawsuit.