FDA Commissioner Scott Gottlieb, halts Essure Distribution

| Oct 9, 2018 | Defective Medical Devices |

doctor with stethoscope and pens

The FDA informed Bayer that the Essure birth control device will not be sold or distributed after this year. In April, the FDA took actions to restrict the sale of the device while they assessed the safety and effectiveness of it after many were experiencing serious side effects. Side effects of women who had the device implanted include perforation, fainting, device migration, and fluid buildup in the blood.

In addition to taking Essure off the market, the FDA has ordered Bayer to conduct a post-market surveillance study to better evaluate the safety of the device. In the past, the FDA also required Bayer to place a warning on the box and include a checklist to help women decide if the device is right for them and inform about potential risks. Since these actions, they have seen a 70% decrease in sales and distribution of the device in the U.S.

Commissioner Gottlieb states in the press announcement published July 20, that they will continue to “remain vigilant” and “continue to monitor adverse events.” Patients who have the device currently should consult their doctor immediately if they think they are experiencing a serious side effect.

Medical Device Safety Action Plan

The FDA’s Medical Device Safety Action Plan claims to “encourage innovation to improve safety, detect safety risks earlier, and keep doctors and patients better informed.” Steps of the Action Plan are:

  • Establish a robust medical device patient safety net in the United States
  • Explore regulatory options to streamline and modernize timely implementation of post-market mitigations
  • Spur innovation towards safer medical devices
  • Advance medical device cybersecurity
  • Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and post-market offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety

Beyer Halting Sales of Essure

Beyer issued a press release stating that they would stop selling Essure in the U.S. for “business reasons,” but that their confidence in the safety of the device had not changed. Despite countless serious injuries, being required to include a black box warning, and other FDA actions, they say that the decision to halt sales is not due to the devices serious side effects or the mandate from the FDA, but the declining sales over the past few years.

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