A Q&A with the FDA about Essure

Morgan Liscinsky, a press officer for the FDA's Center for Drug Evaluation and Research, answered some of our sister station's (KATU) questions about Essure via email. Here's the full conversation, lightly edited for clarity and accuracy. 

Q. Is 2006 the farthest back the data goes? Are there adverse events before that time? If there is earlier data available, can I have those numbers as well please?

A. I’m still trying/waiting to see if I can get the confirmed adverse event figures prior to 2006. (Editor's note: The data go back to 2002.)
 
Q. How much value does the FDA put into adverse events? In other words, on a scale of 1 to 10 (10 being the most valuable, or the most weight put into adverse events) where would adverse events rate in determining a product’s safety?

A. The best type of evidence on which to evaluate the risk of complications with a device is clinical trials. Based on data from prospective and postmarket studies of Essure, the rate of serious adverse events associated with Essure is low.

Secondary to clinical studies, the FDA relies on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices. Adverse event and product problem reports submitted to the FDA are used to monitor marketed medical devices, and these reports may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of reporting system has notable limitations. For example, complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence.  For these reasons, the FDA also evaluates other information to make decisions about a device’s safety and effectiveness. 
 
Q. You mentioned that adverse events are just one tool the FDA uses. What are the other tools the FDA considers when determining if a product or procedure is safe?
 
A. See response to question #2.
 
Essure is a Class III device that received the FDA’s most stringent and rigorous review prior to marketing, using our pre-market approval (PMA) process. The PMA process includes a scientific and regulatory review, including input from an outside panel of experts, to evaluate the safety and effectiveness of medical devices that pose the greatest risk to patients. The PMA process also includes a thorough review of information that should be included in the product labeling, such as warnings or a list of potential risks.
 
Due to the level of risk associated with Class III devices, PMA approval is based on a determination by the FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). In determining safety and effectiveness, the FDA weighs any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.
 
As part of the Essure approval, the FDA required Conceptus to conduct a five-year follow-up post-approval study that evaluated:

  • How well Essure prevented pregnancy.
  • The safety of the procedure used to place Essure.
  • The safety of Essure once implanted, including patient comfort.

Q. Does the FDA have any concerns about Essure? If it does, what is the process the FDA would go through to ensure the consumers who are using it are safe?
 
A. The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from the five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product’s 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. (Because the FDA had up to five year follow-up data from the post-approval study, the literature review concentrated on evaluating long-term complications more than five years after placement.)
 
The FDA takes reports of problems with Essure very seriously and will continue to review them carefully. We will continue to monitor the safety of Essure to make certain that it does not pose an increased risk to public health and safety and that its benefits of providing women with a non-surgical sterilization choice continue to outweigh the  risks of the device.
 
Q. Why does the FDA grant preemption status and particularly for this product, Essure?

A. FDA does not “exempt” devices from lawsuits.  Rather, certain state requirements that apply to medical devices are preempted under section 521 of the Federal Food, Drug, and Cosmetic Act.  Interpreting this provision, the Supreme Court has said that state common law claims relating to approved class III devices generally are preempted.  In other words, people injured from a class III, PMA-approved device typically cannot recover damages from device manufacturers for their injuries under state common law theories. In contrast, the Court has said that such claims are generally not preempted under section 521 when they relate to Class I devices. 
 
Q. Was the data and information on FDA’s new Essure webpage the result of an FDA task force? Or, has the FDA ever put together a task force to look into Essure issues?

A. The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from the five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product’s 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. (Because the FDA had up to five year follow-up data from the post-approval study, the literature review concentrated on evaluating long-term complications more than five years after placement.)