Women who receive an Essure birth control implant for pregnancy prevention may be at risk for side effects such as device migration and perforation of internal organs.

Last year, the first Essure lawsuit was filed against Bayer Healthcare over Essure side effects allegedly caused by the birth control device and many more complaints are expected to be brought against the medical device maker in the coming months, as more information comes to light about the risk of Essure complications.

Essure Side Effects

The birth control implant is offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

However, this permanent birth control device has demonstrated a strong tendency to migrate, which can lead to perforation of the fallopian tube or the uterine wall.

Additionally, women have experienced other Essure side effects, which include severe pain and cramping, blood clots, infection, pelvic pain, depression, weight and extreme fatigue. According to the FDA, nearly 100 women have had to undergo hysterectomies due to Essure side effects.

FDA Responds to Essure Complaints

The FDA has received hundreds of adverse event reports over the past decade involving problems that could be linked to Essure side effects. From 2002-2013, the FDA received approximately 988 reports citing adverse events related to Essure, with over 500 of them occurring in 2013.

After thousands of injuries and several deaths of women implanted with the Essure sterilization device – touted as a safer and less invasive alternative to surgical tubal ligation – the FDA is taking action.

In response to a petition signed by more than 2,100 women urging the federal agency to remove Essure from the U.S. market, the FDA announced recently that it will launch an investigation into the allegations made by the petition’s signers.

The Essure device consists of a pair of metal coils designed to be implanted in a woman’s fallopian tubes, where they induce sterility by irritating the sensitive lining, causing a buildup of scar tissue that blocks passage of sperm and ova between the ovaries and the uterus.

The device was given conditional pre-market approval by the FDA in 2002, a process that grants the manufacturer lifetime immunity from lawsuits related to the device, as long as the company upholds the terms of the approval.

The FDA says this practice – known as “preemption” – is fair because the scrutiny manufacturers must undergo to qualify for pre-market approval is so rigorous that any significant risks would be caught long before the device ever hit the market.

But the petitioners say Essure’s pre-market approval process was unusually rushed, and ultimately rendered invalid by the numerous lies and cover-ups its manufacturer used to fool the FDA into thinking the device was safe.

Essure Lawsuits

Last year, a woman filed the first Essure lawsuit in Philadelphia challenging the application of federal preemption to Essure lawsuits, alleging that the doctrine should no longer apply to Essure. If the case is successful, it could pave the way for other Essure victims to file lawsuits seeking compensation for their injuries. If you or a loved one has taken Essure and experienced severe side effects, you may be eligible to file an Essure lawsuit.