By Diana Zuckerman, PhD
November 4, 2013
The NBC investigation of Essure has raised very important questions regarding the safety of the Essure permanent birth control device. While the company’s study indicates a very high satisfaction rate and a low rate of complications, NBC’s investigation indicates that patients’ reports of chronic, debilitating pain and other health problems were not always included in the data that the company submitted to the FDA. How often did that happen? Unfortunately, we don’t know, and it is essential that the FDA find out.
When new medical implants are studied it is difficult to determine whether health problems that occur afterwards are caused by the device or not. Randomized double blind clinical trials are the gold standard for studying new drugs, but can’t be used for implanted devices — you can’t sterilize some patients using Essure and pretend to do so with other patients — that would not be ethical. But researchers can, for example, compare 500 women with Essure implants to 500 women of the same age and same health status who used other types of birth control, and then objectively study their health to determine whether pain and other reported health problems are more common with Essure than with other types of birth control. That is not the kind of study that the FDA required, and it is not the kind of study that the company did. Instead they just studied women using Essure, without comparing them to other women, and assumed that the health problems the Essure patients experienced were not caused by Essure unless the evidence was irrefutable — such as Essure falling out or causing an infection. That is a very poorly conducted study at best, and the results therefore can’t prove how safe Essure is.
Unfortunately, the FDA has not done its job in protecting the public health, and Essure patients are left understanding the meaning of the warning “let the buyer beware.”