Essure risks are not worth it, say thousands of women who have reported serious side effects.

Essure birth control system is a permanent, non-surgical sterilization procedure for women. It was approved by the FDA in 2002.

Essure uses a pair of implants that are made of stainless steel on the inside and a nickel alloy on the outside. These metal coils are covered in small plastic fibers.

When inserted into the fallopian tubes, Essure implants produce a fibrotic reaction that causes new tissue to grow. After about three months, the fallopian tubes should be blocked, forming a barrier between sperm and eggs.

Essure risks allegedly include:

• Debilitating pain in the ovaries or uterus
• Headaches
• Irregular bleeding
• Nausea
• Flu-like symptoms
• Joint pain
• Muscle weakness
• Abdominal pain
• Painful intercourse
• Back pain
• Heavier periods

Essure Risks Not Seen in Poor Clinical Trials

Critics say Essure clinical trials were allegedly flawed because they followed too few women for too short a time. When the FDA concluded that Essure was 97% successful after one year, that judgment was based on skewed data, according to patient advocates.

Although 926 women enrolled in the study, 181 chose not to have Essure done. Only 85% of the women who actually had Essure were followed up at one year, and only 25% were followed up at two years.

Essure Neglected to Offer Nickel Allergy Warning

Conceptus, the company that created Essure, allegedly convinced the FDA to leave off a label that would have warned people with hypersensitivity to nickel to undergo a skin test to assess whether Essure implantation was appropriate for them.

Conceptus reportedly sought to have the nickel allergy contraindication removed in order to gain a significant advantage over a competitor’s product.

Bayer now owns and markets Essure.

FDA Adverse Events Reports Increase

The FDA reported 5,093 adverse event reports from November 2002 through May 2015. The agency also found 20,000 complaints made by women via social media, reported ABC News.

Famed environmental activist Erin Brockovich has taken on Essure through a website that allows women to share their stories and to sign a petition to get the product withdrawn from the market. She says Essure risks were hidden from women.

“I started this website for women who have had the Essure Procedure so they could share their stories and concerns about Essure,” writes Brockovich on her site.

“Stories from debilitating headaches, nausea, allergic response to the nickel the device is made of, hysterectomies, colon perforation due to device moving, to scans that cannot even find where the device has gone to pregnancy, and the women were told that they could not get pregnant, yet none of the women were told of the serious side effects.”

If you have received this implanted birth control without knowing about Essure risks, you could be eligible to participate in an Essure lawsuit.