Product News and Recalls

New Look at Long-Term Essure Data Adds Fuel to Fire

The female contraceptive market is a crowded one. A variety of options exist, each one tailored to meet a woman’s specific needs or desires for her particular contraceptive method. Some are physical, some are chemical, and others use a combined approach. As a result, a conversation with a physician or gynecologist about contraception can run the gamut.

About 13 years ago, one of the methods that would have come up during such a conversation was Essure. Essure is a small coil that is implanted into a woman’s fallopian tubes. Unlike some contraceptive methods that leave the door open for future pregnancies, Essure’s goal and purpose was to make the woman permanently sterile.

Until Essure, the only option a woman had for permanent sterilization was surgery. Essure offered complete sterilization in ten minutes with a very quick recovery and no surgery. As a result of this new option, Essure was fast-tracked through the FDA’s approval process.

Once approved, reports began streaming in of complications. And, until recently, those consumer reports were among the only criticisms of the device. Formal medical studies about the side effects and complications of Esssure were few and far between.

Until now.

A five-year trial involving 518 women ended in 2007. Now, some eight years later, the data from that trial is finally being made available. The results are striking.

Only 366 women of the original 518 involved in the study were followed through the full five years. Of those:

  • 15 had hysterectomies with 2 being “possibly” related to Essure.
  • 38% experienced recurring heavy periods.
  • 1 in 20 experienced pelvic pain.
  • 1 in 15 had painful periods.
  • 1 in 25 experienced recurring pain during sex.
  • 21 perforations of the fallopian tubes, an expelling of the device, or migrations were recorded
  • 8 surgical sterilizations or operations to remove a coil occurred

A previous study of 269 women, of which only 171 were followed for the full five years, yielded much of the same results. The smaller study also, however, included a pregnancy.

Pregnancy is not that uncommon with Essure. Yale School of Medicine professor Dr. Aileen Gariepy believes that almost 10% of women using Essure would experience a pregnancy over the course of ten years.

At least 4,000 complaints have been filed with the FDA about Essure, claiming everything from pain and discomfort to pierced organs and migrations. Records also exist of over 16,000 complaints given directly to Essure’s original manufacturer, Conceptus. Bayer would later buy a majority stake in Conceptus, thus inheriting Essure.

Bayer and Conceptus keep the information surrounding Essure highly secret. One can see just how secret by trying to read this report filed by Conceptus in June of 2006. The level of redaction it contains rivals documents released by the NSA or CIA. The companies also refuse to state how many women in America have been implanted with the device, stating only that the device has been sold in at least 23 countries with approximately 750,000 of them in use globally.

The level of secrecy surrounding Essure, a consumer device, combined with the volume of complaints about its side-effects – both formal and informal – has caused a social movement of thousands of women to call for the removal of the device from the market. One such group has over 17,000 members on Facebook. Protestors have also taken to the streets in an effort to make their demands known.

The situation surrounding Essure has been long and complicated; made even more so by the secrecy of the companies involved in its manufacture and sale. Lopez McHugh is monitoring Essure activity and will continue to release updates as they are made available.