Thousands of women may have experience Essure complications from the birth control implant manufactured and marketed by Bayer Healthcare Pharmaceuticals.

The device, which is intended to render the recipient permanently sterile, is currently the subject of citizen petition urging the U.S. Food & Drug Administration (FDA) to order an Essure recall.

Among other things, the petition charges that Conceptus, Inc., which launched Essure birth control 13 years ago, perpetrated fraud during its clinical trials.

What Happened?

The Essure System, a form of permanent birth control originally manufactured by Conceptus and then bought by Bayer, was first submitted to the FDA in April 2002 and then swiftly approved by the FDA in November 2002.

Essure birth control works by inserting a nickel-titanium and stainless steel coils (which are wrapped in polyethlene terephthalate) into the fallopian tubes, where the devices irritate the area into developing fibrous tissue, which blocks the fallopian tube and prevents eggs from descending.

Notably, when approving the device, the FDA imposed several requirements on the manufacturer, including requirements that the manufacturer create an adequate training program for physicians, that the warning label include information about failure and success rates, and that the manufacturer continue carefully gathering and evaluating data from clinical trials and from use by physicians.

Although the FDA had required Conceptus to complete its study of the safety and effectiveness of Essure within five years of approval, which would have been 2007.

However, those results were not published until April 24, 2015, nearly eight years too late. Even that late study may have not been properly conducted: only 70 percent of the patients had actually been followed for five years.

Controversy Grows Over Essure Complications

Essure complications have continued to attract media attention. Famed consumer activist, Erin Brokovich has been leading the fight to have Essure pulled from the market.

And in April 2015, a woman involved in the Essure clinical trial told the press she believed her medical records had been altered.

Additionally, The New York Times published a thorough review of Essure in May 2015, reporting that the FDA “has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs.”

The Times also showcased two accounts of women who experienced Essure complications.  Angie F., a 42-year-old mother of four from New York, claims she suffered severe pain and nonstop bleeding for two years after receiving the Essure birth control implant in 2009.

Eventually her doctors found that the Essure coils had broken apart and embedded into in her uterus.  Angie had undergone numerous surgeries, including a hysterectomy to try and remove the broken Essure coils.

In fact, in order to caution others about Essure side effects, Angie created a Facebook page to to warn friends and family about the risks and dangers of the device. Her Facebook page currently has an estimated 17,000 members.

“If I had any idea of the possible consequences of Essure, I would never have chosen it,” said Angie, who still takes pain medication daily to control her pain.

Another woman negatively affected by Essure complications, says she suffered serious symptoms that prevented her from working full time.  Kim H., a 28-year mother to a 7-year old son, volunteer to participate in an early clinical trial for Essure birth control in 2000.

However, shortly after receiving the Essure implant, she experienced a constant sharp in her right hip, along with painful menstrual periods.  She also claims she became very lethargic, suffered from migraines and joint pain to the point she could no longer work full time.

“It felt like I had a really severe case of the flu, and those were the good days,” Kim shares “I had years and years of doctors telling me I was crazy.”

Kim has brought a $1 million lawsuit against the birth control maker seeking compensation for her Essure side effects and lost income.

If you have developed serious Essure complications as a result of the Essure birth control implant, a product liability lawyer can offer you a free and confidential consultation and advise you of your legal options.