After women testified before an Food and Drug Administration (FDA) advisory panel about serious Essure side effects, the FDA has been asked to look into Bayer AG’s Essure sterilization device.

The women who spoke before the advisory panel said that they had experienced a variety of Essure side effects, including pain and bleeding from perforation of the uterus and fallopian tubes. This led the panel to ask the FDA to look into more post-market data on the Essure sterilization device.

While advisers on the panel did not actually vote on Essure sterilization issues, they did ask that the federal agency seriously investigate data related to these allegations of such severe Essure side effects.

Since Essure was approved in 2002, the FDA has received over 5,000 reports of Essure side effects. While the numbers were low in 2011, they quickly rose to the thousands in 2015, bring more attention to the issue.

According to a summary statement released by the FDA, “The panel expressed a general desire to see additional post-market data on the Essure system to better understand the adverse events that were discussed during the meeting.”

“While it was suggested that a randomized controlled trial would be an ideal type of study, many panel members agreed that it would be impractical to conduct such a study at this point in time.”

Essure Sterilization Birth Control Implants

The Essure birth control implants discussed by the FDA panel are meant for permanent implantation in the fallopian tubes. This helps to naturally obstruct the ovaries, which prevents fertilization. According to the device’s website, Essure is the only permanent female birth control device that does not involve surgery.

Bayer has released several warnings about the Essure sterilization device. The product can be a risk to patients who have nickel allergies, since it contains a nickel-titanium alloy. Also, according to the warning, the Essure sterilization device is linked with Essure side effects like chronic pelvic pain.

On top of this, women who get pregnant while implanted with Essure are reportedly more likely than others to have ectopic pregnancies. This is a condition that may be life-threatening and occurs when an embryo begins growing outside the uterus.

Despite the complaints, Bayer claims that its Essure sterilization device has been studied in more than 10,000 women over five years and is reportedly more than 99.8 percent effective.

According to a statement by the company, “Bayer takes all adverse events very seriously. Bayer continuously collects and analyzes all adverse event data it receives and works closely with the FDA in monitoring the safety profile of Essure.”

Essure Side Effects Lawsuits

Many women who have used Essure sterilization have reported serious and severe Essure side effects. These complications include bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage, and ectopic pregnancy.

According to Essure birth control lawsuits, these women were not made adequately aware of the potential Essure side effects linked with the device. Essure side effects lawsuits allege that these devices and their risks were not thoroughly investigated, and that the devices were approved before their risks were discovered.

If you have suffered after being implanted with Essure sterilization, you may be able to file an Essure side effects lawsuit.