FDA to Hold Public Meeting on Safety and Effectiveness of Essure Birth Control Device

Great news for the thousands of women who for years have complained to no avail about health problems they developed following placement of the Essure birth control device. The FDA has scheduled a public meeting on September 24, 2015 in Washington, D.C. to review data about the safety and effectiveness of Essure, and is seeking comment from the public about their experiences with Essure. If you believe you have suffered health problems due to Essure, this is your opportunity to add your voice to the chorus of complaints involving this medical device.

Essure is a birth control device offered as a non-surgical option to tubal ligation and laparoscopy. The FDA first approved Essure in November 2002 for use by women ages 21 – 45 years old. It is the only FDA-approved non-surgical permanent form of birth control available in the United States. Conceptus Inc. originally developed and manufactured the device from the time of its FDA approval in November 2002 until Bayer HealthCare (“Bayer”) acquired it and the rights to manufacture, market and distribute Essure in 2013.

Essure placement can be done without surgery and with minimal recovery time and can be completed in about 10 minutes in a doctor’s office. A healthcare professional inserts the soft, flexible metal coils made of a titanium-nickel alloy through a catheter into the vagina and cervix finally placing them in the fallopian tubes. Over the next 3 months, scar tissue develops around the coils blocking sperm from getting into or eggs from getting out of the fallopian tubes thereby preventing the eggs from being fertilized and moving into the uterus. At the 3-month mark, x-rays are taken to confirm the tubes are completely and permanently blocked.

A Litany of Complaints and Health Problems after Essure placement

Since its FDA approval in 2002, more than 750,000 women have had the device placed; however, the FDA has also received more than 5,000 reports from women describing adverse reactions and health problems including,

  • Excessive bleeding
  • Abdominal pain
  • Back pain
  • Perforated tubes or uterus by the coil
  • Coil movement and broken device
  • Pregnancy
  • Increased risk of ectopic pregnancy (pregnancy in the fallopian tubes)
  • Depression
  • Chronic fatigue
  • Allergic reactions to nickel in the device
  • Bloating
  • Weight gain

The FDA is also investigating reports of 4 Essure deaths and 5 fetal deaths from miscarriage occurred in women who still got pregnant after the device was placed.

E-Sisters versus the big bad Bayer

The E-sisters as they’re known—the women who believe they suffer negative health issues because of Essure—have banded together on social media platforms to vent their frustrations, find understanding from other women who also suffer negative health effects from Essure, and a crusade for the device to be banned from the market. To them, this public meeting means their collective cries are finally too loud for them to be ignored by their doctors, the FDA and the device maker, Bayer.

On the flip side, Bayer argues that these thousands of women are “not representative” of the typical Essure patient and that Essure is perfectly safe given the more than 750,000 women who have the device without complication. Bayer also points to a 5-year study which failed to show any additional safety concerns or increased risks beyond those already known at the time of FDA approval, and no evidence of chronic fatigue, depression or weight gain, although it’s worth noting these studies were conducted by Bayer and Conceptus, both of which have a vested interest in the success of Essure.

If You Want to Tell Your Story, Here’s What to Do

 If you or a loved one feels you were injured by Essure, or have suffered health problems since its implantation, now is the time to send your story to the FDA. You can submit data, information and your views either in writing or electronically, or appear in person to speak at the meeting, but there are submission deadlines you need to follow. Open this link to get all the information on all deadlines and procedures to submit your complaints and concerns. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm455642.htm

What’s Next?

The FDA will consider a multitude of options after the meeting. The biggest question to be answered is whether Essure is causing all the health problems about which these women complain. If the FDA finds Essure IS causing these problems, it could order Bayer to make labeling changes warning of additional possible risks and side effects; it may require Bayer to conduct additional research on Essure’s safety and effectiveness; it could order more research on the long-term effects of the device on the overall health of the woman not just on its effectiveness in preventing pregnancy; or it could remove the device from the market. Not surprisingly, the women who have been injured by the device hope it is removed from the market.

For now, the FDA has updated its list of short and long-term risks from Essure, which you can find here: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452250.htm