By Diana Zuckerman, PhD
Updated November 6, 2014
It’s been over a year since the NBC investigation of the contraceptive Essure, and now ABC and other media are also involved. The latest investigation provides even more evidence that perforations and other serious problems caused by Essure were not reported to the FDA in a timely manner, if at all. The original investigation, showing that the company misrepresented safety data to the FDA, remains the major concern.
Unfortunately, the FDA continues to stonewall, apparently failing to check to see if the scientific data submitted to them years ago is accurate or was misrepresented. This is just unacceptable. Women deserve to know that contraceptives that the FDA approves are truly safe and effective and that the data FDA relies on are accurate. It is especially worrisome given that Bayer, the maker of Essure, has previously been accused of similar misrepresentations regarding the safety of Yaz, Yasmin, and other contraceptives that they make.
Diana Zuckerman’s Original Statement, 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.”