Statement Regarding FDA Restrictions on Essure Sterilization Device of Dr. Diana Zuckerman, President of the National Center for Health Research

The FDA’s decision is an effort to guarantee that women considering Essure are informed of the risks. If that is effective, it is an important step. However, there are clear problems with the checklist that is intended to help women make an informed decision. The first, obvious problem is that the checklist is part of a Patient Booklet written by Bayer that is 22 pages long. The checklist should be provided separately from the rest of the booklet, because any health communication expert can tell you that most patients will not read a 22-page document before signing it.

Equally important, much of the information provided in the booklet and in the checklist is based on data that have been questioned by experts in the field. That is why a well-designed long-term study of women who underwent Essure sterilization compared to tubal ligation is so important – and long overdue.

Read the press release here.