Product News and Recalls

Essure Now Faces Congressional Ban

essure facing congressional calls for banPlenty of medications and medical devices have faced the wrath of a displeased public. Thanks to the amplifying power of technology, it is now nearly impossible to ignore an organized group of citizens who have determined that a product or company is not aligned with their best interests. Recalls, black box warnings, and changes to entire product lines have occurred as consumers have confronted company after company; forcing them to acknowledge the concerns of their customer base.

The story of Essure, however, is unique. Opposition to Essure, a non-surgical alternative for female sterilization, started almost from the first day the device was released to the market. Reports of bleeding and incredible pain met reports of device migration and organ perforation, and began pouring in to Bayer; Essure’s manufacturer. Some would also go straight to the Food and Drug Administration.

No matter the number of complaints or their severity, however, these reports fell largely onto deaf ears. Corporate and government inaction would then lead tens of thousands of women to take to social media to organize instead.

Finally, in the summer of 2015, the FDA acknowledged the outcry over Essure and scheduled public hearings.

U.S. Representative Mike Fitzpatrick of Levittown, Pennsylvania is not satisfied with a simple set of public hearings. The Congressman is preparing a bipartisan piece of legislation to move through the House of Representatives that would ban the continued use of Essure in the American healthcare market.

Citing hundreds of complaints received by his office, Fitzpatrick complemented Bayer on their position in the market but noted that, in the face of overwhelming evidence, the facts about Essure were indisputable. In a statement prepared and released by the Congressman, he said, “Bayer is a trusted name in the industry. However, right now, one of their products, the Essure device, is harming women and needs to be removed from the market. I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”

Congressional action on consumer product safety issues is rare, with the legislative body preferring to leave regulation to regulatory agencies. However, when moved to act, the result is often in-depth investigations and, at times, criminal proceedings. Such is the case with the current activity over power morcellators; as Congress and the FBI work to determine if a cover-up took place at Johnson & Johnson to mask how much the company knew about the cancer risks posed by its surgical devices.

For its part, Bayer has not formally addressed the Congressman’s accusations or concerns, preferring instead to focus primarily on those levied by the FDA. Lauding its own concern for patient safety, the pharmaceutical giant “stands by the positive benefit-risk profile of Essure,” according to a prepared statement. The company also notes that, as part of its focus on the safety of its customers and patients, it implemented a help line specifically for Essure customers. Patients can call a Bayer-compensated nurse to discuss any issues with their implants.