Essure birth control: questions for the FDA

Thousands of women across the country are speaking out about their experiences with a form of permanent birth control called Essure.  Many of the women who came forward to the 7 Action News Investigators say it was one of the worst decisions they've ever made and they want Essure taken off the market.

Here are several questions the 7 Investigators posed to the FDA, and the responses about Essure:

1) Is the FDA planning to take a second look at ESSURE or require any additional studies?

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.

2) Why did the FDA approve taking the skin test warning off the product when they had records of Conceptus telling the FDA that a skin test was necessary to avoid placement in women with nickel allergies?

Some patients with nickel sensitivity can be prescribed the Essure system for permanent birth control. Typical symptoms of nickel sensitivity that may be associated with Essure include rash and itching. Essure is the only non-incisional, non-hormonal form of permanent birth control for women.  Physicians and patients need to discuss the potential for a reaction to the nickel component of the micro-insert as they weigh the benefits and the risks of Essure in each individual case.

The FDA approved a 2011 PMA supplement to remove a nickel contraindication because there was no evidence from laboratory (bench) testing data, literature, market history information, and clinical trials to support a contraindication for nickel sensitivity. In addition, clinical trial data has shown that the risk of a sensitivity reaction to the Essure device is less than 1 percent.  Currently, the labeling includes a nickel warning.

3) Does the FDA plan to require the manufacturer (now Bayer) to change the warning label to clear up the confusion about this device? Many women tell me they have racked up significant medical bills getting the device removed after their doctors assured them it was safe for people with nickel allergies.

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.

Patients with pain or other health problems should seek a comprehensive evaluation and work with their health care provider to have a thorough evaluation and to receive the proper follow-up. It is important to know that all devices involve risk; known adverse events that can occur with Essure are listed in the product labeling. The FDA strongly encourages you to submit a voluntary report about any problems you have experienced with Essure through MedWatch, the FDA Safety Information and Adverse Event Reporting program . Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. The FDA reviews the MedWatch reports and takes any necessary action to protect public health. 

No form of birth control is 100 percent effective and scientific evidence shows that Essure is a highly effective means of sterilization when health care providers and patients follow the appropriate instructions for use. Essure is also the only non-surgical sterilization choice for women who want permanent birth control.

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