Safety concerns over new female sterilization device

The Essure device received approval in Europe in 2001 and was approved in the USA in 2002. The study found that women who’d had hysteroscopic treatment were 10 times more likely to need a repeat operation within a year – equalling around in 1 in 50 women.

The study in the British Medical Journal analysed data from 8,048 women who underwent hysteroscopic sterilisation, and 44,278 who underwent laparoscopic sterilisation as outpatients in the United States between 2005 and 2013.

Hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy one year after surgery (odds ratio, 0.84; 95 percent confidence interval [CI] 0.63 to 1.12) but was associated with a substantially increased risk of reoperation (odds ratio, 10.16; 95 percent CI 7.47 to 13.81) compared with laparoscopic sterilization. Thousands of women have said that the device has hurt them.

Essure was linked to an extra 21 re-operations per 1,000 patients undergoing surgery according to the study with the authors warning that this increased rate was a “serious safety concern”. The American College of Obstetricians and Gynecologists considers Essure as effective as surgical procedures and, in a few respects, safer.

The implants are usually inserted under local anaesthetic, and the procedure does not require cuts to be made in the abdomen.

However, a number of problems have been reported following the hysteroscopic approach. They did find that although the device is supposed to be placed without the use of general anesthesia, which can itself be unsafe, about half the women were put under, anyway.

New research raises concerns about Essure, an implanted long-term birth control device that’s already the focus of controversy.

The risks of removal remain unknown because various techniques used have not yet been assessed in clinical studies.

Data from the FDA shows that it received more than 5,000 reports about Essure between 2002 and May this year. Abdominal pain was the side effect most often reported by women to the FDA, followed by heavier menstrual periods. But more women who had Essure experienced complications that meant they needed repeat surgery.

In 482 cases, patients said the device had migrated to elsewhere in their body while 259 reported the device breaking. Reports have also associated it with a higher risk of unintended pregnancy. (“Guns: They’re here to stay!”) Personally, I enjoyed even more her Comedy Central piece contrasting the ridiculous burdens on women trying to obtain birth control, with the relative ease of buying a gun in America.

The researchers say their study found a higher risk of an unwanted pregnancy in women who had had both types of sterilisation than in previous studies.

“This study is important because it looked at Essure women in the real world, not the more ideal world of clinical trials”, said Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer research group.

Essure, manufactured by Bayer Healthcare, is a permanent birth control device that blocks the fallopian tubes; thus, preventing pregnancy. The need of re-operation remained high over years.

“Because there is no confirmation test that could identify potential failure of a laparoscopic tubal ligation procedure, it stands to reason that the comparative reoperation rate would be lower”, said a spokeswoman.

The law firms Leigh Day and Irwin Mitchell confirmed they had been contacted by Essure patients and were investigating claims on their behalf.