Essure implants will no longer be marketed or sold anywhere in the world with the exception of the United States, announced Bayer on Monday, Sept. 18, 2017.

Bayer has combatted numerous patients and women’s advocacy groups who allege Essure implants are dangerous, but Bayer insists the device is being yanked from other markets only because of commercial reasons.

A Bayer statement said, “We would like to reassure the Essure patients and their accompanying healthcare professionals that this decision is made for commercial reasons and that it is not related to a safety or product quality issue.”

The statement goes on to say that communities outside the U.S. became “an environment unfavorable to its prescription,” which led to “a continuous decline in demand” for Essure implants.

Essure Implants Allegedly Not the Easy, Safe Protection Advertised

More than 750,000 women have received Essure implants, and the FDA has received more than 32,000 complaints and 10,000 adverse even reports regarding Essure.

Even though the label indicates women might experience pelvic pain and bleeding upon the implantation’s completion, thousands of women report persistent health complications that greatly interfere with their ability to enjoy life. A Facebook page dedicated to these women’s stories has upwards of 34,000 members.

Essure consists of two small metal and plastic coils that are inserted into the fallopian tubes, which are inserted through the vagina. This ease of implantation drove the first wave of women willing to give the birth control option a try in lieu of undergoing surgery to have their tubes tied.

Over the course of several months following implantation, scar tissue grows in and around the coils, theoretically blocking the fallopian tubes to stop the eggs’ release.

Essure implants are reportedly linked to the following issues:

• The Essure coils are “blindly” implanted into the fallopian tubes through the vaginal canal, making accurate positioning difficult. Even if left in the correct place, coils can migrate or puncture the fallopian tubes, causing great pain and prompting the need for surgical removal.

• The coils are made of a nickel-based alloy. The Centers for Disease Control and Prevention estimates that between 10 and 20 percent of the population is allergic to nickel. Inflammation, joint pain, and rashes can be indicators of a nickel allergy.

• Although Essure implants are designed to be a permanent birth control measure, the metals can degrade due to high nickel ion release, which increases the risk of metal poisoning in patients.

• The plastic used in the surfacing of the coils is made of PET plastic, which is known to degrade and leach toxins when it reaches a temperature of 85 degrees. Because the body is 98.6 degrees, these toxins release into the human body, potentially causing chronic inflammation and possible autoimmune responses.

Despite thousands of reports of debilitating joint pain, heavy periods, fatigue, rashes, headaches, cramping, painful intercourse, and more than 300 reports of ectopic pregnancies, the FDA and Bayer insist Essure implants are safe.

Bayer’s latest statement says, “Essure’s positive benefit-risk profile remains unchanged. Essure’s safety and effectiveness remain supported by more than ten years of scientific research and real-life clinical experience.”

The FDA also continues to say “the benefits of the device outweigh its risks.”

If you or someone you love has been injured by Essure implants, you could benefit from speaking with an attorney regarding your legal rights.