Essure, by Conceptus, Inc., approved on Nov. 4, 2002, is a Class III device that received FDA's most stringent and rigorous review prior to marketing, using our pre-market approval (PMA) process (this is not a 510(k) device). 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.
Essure has been shown in a rigorous prospective clinical trial with 5-year follow-up to be effective at preventing pregnancy, which is the intended use of the device. The device labeling (physician and patient) describes risks of the procedure. The currently available alternative to Essure for permanent female sterilization requires at a minimum laparoscopic surgery (including a skin incision and general anesthesia).
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 just one source we use 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 once a device is on the market, including post-approval studies and review of the clinical literature.
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. The agency also reviewed the results from a five-year follow-up post-approval study conducted by the device manufacturer 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.
Some of the recent patient reports of problems describe potential complications that were documented during clinical studies and are addressed in Essure labeling (e.g. pain, nickel allergy, abnormal bleeding, perforations and device migration). Other reports of problems received from Internet testimonials and emails describe symptoms (e.g. extreme fatigue, depression, and weight change) that are not included in labeling, were not observed in post-approval studies and are not described in peer-reviewed medical literature.
We take reports of problems with Essure very seriously and will continue to review them carefully. Since approval in 2002, there have been some 750,000 procedures performed worldwide. No form of birth control is 100 percent effective and scientific evidence reviewed by the FDA shows that Essure is a highly effective means of sterilization when used according to instructions. Essure is the only non-surgical sterilization choice for women who want permanent birth control. Although there is evidence of complications, as there are with all medical devices, overall results from the study did not demonstrate any news safety problems or an increase incidence of problems already known. We will continue to monitor the safety of this product to make certain its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.