On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers can implant Essure up to one year from the date the device was purchased. Bayer will continue to implement the FDA’s restriction on sale and distribution of Essure from April 2018, to ensure women are fully informed of the risks associated with the device.
The FDA continues to take concerns about Essure very seriously; ensuring the safety and effectiveness of medical products is an agency priority and core part of our consumer protection role. Women considering permanent birth control should make fully informed decisions by getting information from their health care provider about the risks and benefits of all options. The FDA continues to believe that, for the majority of women, the benefits of the device, when placed by an experienced health care provider, outweigh the risks, and that Essure’s updated labeling and the sales restriction help to assure that women are appropriately informed of the risks.
Dr Garza can remove this product. Want to learn more about the procedure? Click below on the video or feel free to call Dr Garza’s office for a confidential consultation at #512.425.3835.
*All above information is from the FDA website, and this material is for educational purposes solely, and not company sponsored.