Product News and Recalls

Essure Battle May Be Shifting as FDA Schedules Hearing

fda schedules public essure hearingThe fight over Essure may be entering a new phase as the US Food and Drug Administration announced a public meeting to review the data surrounding the female sterilization device. This represents a significant victory for the thousands of women who have been campaigning, primarily via social media, for more attention to be paid to them, their injuries, and the role they believe Essure played in those injuries.

Essure was developed by Bayer as a non-surgical alternative for female sterilization. Up until Essure, women who wanted to end their ability to have children relied on tubal ligation or, in more common terms, having their tubes tied. The procedure was a surgical one that involved hospitalization and recovery time. Essure is a device that is implanted non-surgically in a woman’s fallopian tubes. The device is intended trigger the development of scar tissue around it which, over time, would block the tube and cause sterilization.

Reports of issues with the device began almost immediately after its release with reports of bleeding and intense pain, as well as device migration and perforation of other internal organs.

Complaints to Bayer and numerous federal agencies garnered little attention or response. As a result, injured women took to social networks like Twitter and Facebook to come together, share stories, and coordinate.

That coordination soon turned into a movement, and it is by no means a small one. Essure Problems, the largest Essure associated group on Facebook, boasts close to 19,000 members. Other Essure-focused groups, mostly regional collections of women from specific states, have membership ranging from the hundreds to the thousands.

The FDA meeting is being hailed as a victory by those involved with the fight against Bayer. They hope that it signifies an acknowledgement that there may be a real problem for women all across the country.

Bayer is, of course, touting the meeting as an opportunity to clarify certain facts about the device; specifically what is referred to as its “risk-benefit profile.” All medical devices and drugs are gauged on their potential benefits to a patient versus the risks associated with using them. However, other facts about Bayer and Essure are sure to come to light. Allegations recently surfaced in a Philadelphia case which questioned not only whether untrained physicians were implanting patients with Essure but, in some cases, they were allegedly also using equipment provided by Bayer which was not FDA approved for such use.

Tens of thousands of women will be watching these FDA proceedings very closely and with cautious optimism. The outcome will set the stage for the next phase of their battle – a battle which, for now, appears to be shifting.