The release of a long-term report that studied the complications of the birth control implant Essure has led to numerous lawsuits.

Essure was once considered a medical breakthrough in contraceptives for women who wanted to be permanently sterile but didn’t want to undergo surgery. However, thousands of women who allege the contraceptive implant Essure caused them severe pain and injury are asking the FDA to take the product off the market.

The FDA fast-tracked the approval process for Essure 13 years ago, as the small metal and polyester coil provided an alternative to tubal ligation surgery (tubes tied). However, since the contraceptive implant was marketed to last a lifetime, FDA officials were concerned that the initial clinical studies that followed women for a year or two were not sufficient. Approval for the contraceptive implant came with the understanding that study participants would be monitored for up to five years.

The release of that five-year clinical study came last month, an unconventional eight-years after the study ended. The Journal of Minimally Invasive Gynecology reported the following information on the long-term data collected:

• Only 70 percent of original study participants were followed for five years
• 1 in 15 reported continuous painful periods
• 1 in 20 reported ongoing pelvic pain
• 1 in 25 reported painful intercourse
• 38 percent reported recurring heavy periods
• 15 women had hysterectomies (investigators deemed only two were “possibly” related to Essure)

These long-term clinical findings confirm what thousands of women have already reported regarding Essure side effects. Since its approval, more than 4,500 serious adverse event reports have been filed with the FDA from patients who claim Essure caused:

• Excessive menstrual bleeding
• Organ perforation
• Severe back and pelvic pain
• Bloating
• Allergic reactions
• Miscarriages
• Ectopic pregnancy

Essure Birth Control Overview

Essure was marketed as the first non-surgical form of sterilization that could be implanted in a doctor’s office in just 10 minutes. This provided women with an alternative to permanent birth control that didn’t require surgery or a recovery time. The birth control implant was first manufactured by Conceptus before Bayer purchased it. Bayer estimates nearly 750,000 Essure birth control implants are used around the world.

The way Essure is supposed to work is that two coils made of metal and polyester are inserted through the vagina and uterus and placed inside each fallopian tube. This process can be performed without surgery. Over the next few months, scar tissue begins to develop around the metal coils which blocks the fallopian tubes and prevents conception. The process of developing tissue around the coils can take three months, so women who get an Essure implant must follow up with their doctor to confirm the procedure worked before relying on it as permanent birth control.

Essure Lawsuits

Several Essure patients have filed lawsuits against Bayer citing serious long-term complications of the birth control implant. One of them is Kim H., who participated in an early trial of the implant. Kim alleges that once implanted with the device she began having continuous pain in her right hip. She also claims the Essure birth control caused painful menstruation, joint pain, migraines, and fatigue.

Kim alleges due to the serious Essure side effects, she was often unable to work. Kim is seeking $1 million in damages from Bayer HealthCare for injuries and economic loss of wages.