Essure Black Box Warning – A Roar without Any Bite

This post was inspired by a real-life hero, Dr. Julio Novoa. In fact, the title comes from a letter he wrote (reproduced in part and linked with his permission) regarding Bayer’s “permanent” birth control device, Essure. For those unfamiliar with Essure, there are numerous posts on this site about the device and the dangers thereof. For those unfamiliar with Dr. Novoa, he is an outspoken physician advocate of removing this dangerous product from the market. His is one of the strongest, loudest voices calling for its removal. He is also one of the most outspoken critics of the FDA’s handling of the issue. Case in point: the Essure black box warning – a roar without any bite.

This post was inspired by a real-life hero, Dr. Julio Novoa. In fact, the title comes from a letter he wrote (reproduced in part and linked with his permission) regarding Bayer’s “permanent” birth control device, Essure. For those unfamiliar with Essure, there are numerous posts on this site about the device and the dangers thereof. For those unfamiliar with Dr. Novoa, he is an outspoken physician advocate of removing this dangerous product from the market. His is one of the strongest, loudest voices calling for its removal. He is also one of the most outspoken critics of the FDA’s handling of the issue. Case in point: the Essure black box warning – a roar without any bite.

Some background is important. While there is a lot of content on this site about Essure, a brief explanation of the product may be helpful. Essure is an implantable medical device composed of Nitinol (nickel-titanium) and PET (polyethylene terephthalate) fibers. The device is inserted into a woman’s fallopian tubes where it is expected to initiate an inflammatory response leading to permanent scar tissue blockage of the tubes and permanent sterilization of the patient. Over the decade-plus that it’s been on the market, it has caused multiple tens of thousands of women horrible suffering and pain. In some cases, it’s even cost them their lives. What has the FDA done about this?

After years of patients lobbying for change, the agency spent five months deciding that the best approach was a black box warning and Draft Guidance for Industry and FDA Staff document (DGI). As Dr. Novoa states in his letter, this really doesn’t amount to much protection at all.

Here is the text of the proposed black box warning:

“WARNING: Some patients implanted with the Essure System for Permanent Birth Control have reported adverse events, including perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions. Some of these reported events resulted in device removal that required abdominal surgery. This information should be shared with patients considering sterilization with the Essure device during discussion of the benefits and risks of the device.”

Dr. Novoa wrote, “Unfortunately, both the BLACK BOX WARNING and the DGI document are provided as reference documents for physicians and the public in general, but are not required to be used, nor is the dissemination or discussion of either document by the physician to their patient mandatory or legally enforceable.”

In other words, your doctor may choose to ignore both of these items, giving you only part of the information you need (as a patient) to give your truly-informed consent to the procedure. He continued, “Nevertheless, the FDA requiring a BLACK BOX WARNING, in part validates what has been known for over a decade, which is the fact that the ESSURE device has significant side effects to include maternal and fetal death. Unfortunately, this change in labeling will do very little to change the minds or behavior of those doctors that wholeheartedly support the device. In fact, it is not unrealistic to opine that for those doctors and organizations that associate the ESSURE [device] with an incredible level of convenience supplemented by incredible monetary gain, the BLACK BOX WARNING and the FDA ESSURE Guidance document will simply be ignored.”

Dr. Novoa graded three examples of informed consent forms in his letter and found all of them deficient. One was close to acceptable, but still missed the mark.

According to his letter, “each of these examples fails to document any of the most concerning problems documented in the literature and which have been extensively discussed online for the past 5 years regarding the ESSURE device. These include the following:

1. The ESSURE Permanent Birth Control Device is classified as a Class Ill device. ‘Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices.’
2. Due to its Class III classification, if the device were to cause any harm for reasons found to be associated with the device, the patient would have no recourse to seek monetary compensation for injuries caused by the device from the manufacturer of the device, which is the Bayer Corporation.
3. On September 24, 2015, an OBGYN advisory committee for the FDA recommended a number of changes to the current marketing and advertising of the ESSURE device to include additional data gathering regarding complications associated with the device such as autoimmune and chronic allergic reactions to the device.
4. Due to a significant number of complaints associated with the device, a Congressional bill, the Fitzpatrick [E-Free Act], is currently in review in order to permanently ban the ESSURE device from use in the United States.”

Dr. Novoa feels so strongly about this device that he has added an Essure page to his practice’s website. As the page states, “Novoa Medical Services’ goal is to provide women with information concerning the ESSURE device in order for them to make an educated decision regarding the use of this product for birth control.”

If you or a loved one has or is considering getting this device, I strongly recommend visiting Dr. Novoa’s site. You will find good information, along with a well-written and comprehensive informed consent document. You will also find good information and support at the Essure Problems Facebook group.

In the interest of full disclosure, I am not financially affiliated with Dr. Novoa or Novoa Medical Services. I am, however, a staunch advocate for the removal of this dangerous device from the market. As such, I report on news regarding Essure, as well as providing helpful information like that found in this post.