Essure Side Effects
From November of 2002 — when the FDA first approved Essure — to December 2016, the federal government received 14,919 medical device reports related to the product. More than 10,000 of these reports pertained to general pain and, specifically, abdominal pain. Others addressed menstrual irregularities, headaches, fatigue and weight fluctuations.
In 2011, the FDA approved updated labeling for Essure which warned patients about nickel sensitivity. The Essure inserts contain metals — including nickel, as well as titanium, iron, chromium, silver-tin, platinum and polyethylene terephthalate — and patients who are allergic to such metals may have a reaction. Symptoms include rashes and hives, but also more serious issues such as chest pain and difficulty breathing.
Other side effects related to Essure reported frequently to the FDA involve device incompatibility, migration of the device, difficulty inserting and removing the device, and device breakage. The FDA notes that single patients sometimes reported multiple issues.
Essure’s labeling was updated again in 2013 to include risks of chronic pain and device migration. Then, in 2016, the FDA recommended a black box warning emphasizing the product’s “significant side effects.”
The risks — or possible side effects — listed for Ensure by Bayer are separated into a few different categories. There are risks associated with the procedure, those to watch for immediately following the procedure, risks associated with the confirmation test and long term risks.
During the Essure procedure, part of an Essure insert may break off, requiring the doctor to remove the piece. There is also a risk of the hysteroscope, or other tools used in the procedure, or the Essure system itself perforating the uterus or fallopian tubes; this could lead to bleeding or injury to the bowel or bladder, which would require surgery.
Immediately following the Essure procedure, patients may experience side effects including pain and cramping, vaginal bleeding, pelvic or back pain, headaches, nausea, vomiting and dizziness. The insert could also be expelled from the body.
During the confirmation test, an x-ray is required. Patients may be exposed to low levels or radiation during this test. Other side effects associated with the test include nausea and vomiting, dizziness or fainting, cramping, pain and discomfort. Women might also experience spotting or an infection.
Long term risks include pain, device misplacement and nickel sensitivity. The manufacturer also notes that ectopic pregnancies — pregnancies outside of the uterus — may occur with Essure. Such a pregnancy typically occurs inside the fallopian tube and can be life-threatening.
Bayer also makes mention of some “unknown risks.” These issues have been reported to the FDA, but were not observed in the manufacturer’s clinical trials. Issues include headaches, fatigue, hair loss and mood changes.
Women experiencing issues with the Essure are sharing their experiences on a website dedicated to the procedure . The site was launched by legal activist Erin Brockovich and, in addition to a collection of personal accounts relating to the procedure, also features a petition calling for Essure’s removal from the market.
In 2016, the FDA ordered that Bayer conduct a “postmarket surveillance study” to gather more data on Essure’s risks and benefits. The agency feels the study and additional clinical data will “help to better understand certain patient complications.”
Black Box Warnings about Essure
The FDA has issued a black box warning for Essure. Black box warnings represent the most severe warnings the government can impose.
In October 2016, the FDA issued its guidance concerning labeling for Essure. The agency identified two additions the labeling needed: a “decision checklist” for the doctor and patient to use when considering using Essure, and also a boxed warning containing a safety statement “to better communicate to patients and providers the significant side effects of complications associated with these devices and information about the potential need for removal.”
When considering its labeling guidelines for Essure, the FDA considered feedback from a 2015 advisory committee and public comments. The sentiment of the committee and comments was that the product’s labeling did not clearly communicate Essure’s potential risks.
As of 2016, the black box warning for Essure alerts patients of potential “adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.” It also warns that if the device needs to be removed to address any of these adverse events, surgery will be required.