Bayer Healthcare has announced that it is taking Essure off the market outside of the U.S. The company asserts that its decision to pull Essure off the market was made for commercial reasons because non-U.S. markets are less interested in permanent birth control options like Essure. However, Bayer has dealt with its share of safety problems related to Essure over the years.

The Essure device has been linked to a number of serious complications. There are now more than 4,500 adverse event reports reported to the FDA. Women allege suffering from a range of side effects, including miscarriage, organ perforation, and fatalities.

The severity of Essure side effects led the U.S. Food and Drug Administration to place a Black Box warning on the device in 2016.  The FDA warns about possible complications like persistent pain, perforation of the fallopian tubes or uterus, and other major problems that may lead to surgical removal. A Black Box warning is the highest-risk label provided by the FDA.

Essure sales were suspended in Canada and several other countries this last May. The suspension of Essure sales came after a slew of reports involving a number of Essure side effects, ranging from allergic reactions and abnormal bleeding to perforation of fallopian tubes and revision surgery.

As of yet, despite lawsuits against Bayer over Essure side effects and a plethora of adverse event reports, the company has not pulled the Essure device in the U.S. However, with Essure off the market in foreign countries, some expect Bayer to soon pull Essure off the market in the U.S. as well.

Patients and safety advocates have called for the FDA to stop Essure sales in the U.S. market due to the serious risks that have been associated with the device. Many have demanded more research into these side effects.

Essure Background

Essure is a popular form of permanent birth control, a device made up of two metal coils lined in a thin fabric and placed in a woman’s fallopian tubes in an outpatient procedure. Essure was designed as an alternative to other permanent birth control methods like surgical tubal ligation. Essure was first approved by the FDA back in 2002.

While side effects should be expected from any medication or medical device, many patients who were implanted with Essure claim that the Essure complications are more harmful than should be allowed. Thousands of women have reported serious Essure side effects since the device’s FDA approval.

Essure Side Effects

Major Essure side effects include:

• implant failure
• device migration
• organ perforation
• device fracture
• ectopic pregnancy

Any of these side effects can be quite serious and have dangerous and lasting effects. Some patients who suffer from these kinds of Essure adverse effects require removal surgery, but removal surgery carries its own risks, as well as additional medical expenses.

Filing an Essure Lawsuit

Numerous women have already filed lawsuits against Bayer over Essure side effects, and more keep coming. According to Essure lawsuits, Bayer Healthcare failed to adequately warn patients and the medical community about major Essure complications, placing patients at risk.

If you or someone you love has suffered from Essure side effects or any of these other complications after being implanted with the birth control device, you may have cause to file an Essure lawsuit against Bayer. While filing a lawsuit cannot take away the pain and suffering caused by Essure side effects, it can help to compensate for the financial cost of medical expenses and lost wages.