A number of lawmakers are calling for the Food and Drug Administration (FDA) to force Bayer to issue a recall for the Essure birth control implant.

The lawmakers are calling for the federal agency to withdraw its original approval amid reports of complications and Essure problems experienced by women across the country.

Pennsylvania Rep. Mike Fitzpatrick introduced the E-Free Act in the House on Nov. 4, 2015. If approved, it would revoke the pre-market approval given by FDA to Essure’s original developer, Conceptus, in 2002.

This would require Bayer, who currently owns and distributes the birth control implant, to remove Essure from the U.S. market.

The FDA is currently reviewing data on adverse events associated with Essure and is expected to publish its recommendations in late February 2016.

About Essure

Approved by the FDA in 2002 via the agency’s “fast track” system of review, Essure is a non-surgical and permanent form of birth control, or female sterilization, which has two flexible coils that are inserted through the vagina. The problem is that these Essure coils contain a nickel-titanium alloy which many women are allergic to and causes a plethora of health issues.

Worse, reports indicate the Essure device has a tendency to migrate elsewhere in the body after implantation. Women may require multiple surgeries to remove the device and/or address any internal damage caused by the device, including perforated or damaged organs such as the uterus and the fallopian tubes.

Essure Problems and Complications

In June of 2015, the FDA added information to it’s website related to the risks associated with Essure. The FDA has received at least 5,093 adverse event reports since Essure birth control was approved in 2002.

There were 152 complaints filed in the FDA’s Manufacturer & User Facility Device Experience (MAUDE) database in 2012; last year the number of complaints filed in the database jumped to 2,259, a 1,386 percent increase.

Some of the reported Essure problems include:

• blood clots
• serious rashes
• allergic reactions
• excessive bleeding
• organ perforation
• severe cramping and pelvic pain
• miscarriage
• ectopic pregnancy
• implant migration
• surgery

If the Essure implant separates, breaks or moves, attempted removal often requires multiple surgeries, sometimes requiring removal of the uterus entirely.

A study published on October 13 in the medical journal the BMJ indicated women who undergo the Essure birth control procedure may be ten times more likely to need additional surgery due to complications than women who undergo tubal ligation, an alternate form of female sterilization.

If you or a loved one opted to have Essure coils implanted for purposes of permanent, non-hormonal female sterilization and suffered adverse side effects, you may be entitled to compensatory damages.