What You Should Know About Essure and Nickel Allergies

A woman suffering from a nickel allergy due to Essure

A few years ago, The New York Times published a story about how the rising popularity of devices like Fitbit fitness trackers led to a spike in allergic reactions. Consumers were frequently developing rashes and skin irritation in and around the area where the metal underside of the devices made contact with their skin. As it turned out, unknown and undiagnosed nickel allergies were to blame. In some severe case the rash and irritation spread well beyond where the metal met the skin, causing severe itching, pain, and blistering.

Now imagine that same allergic reaction occurring inside your uterus.

That’s the reality many women are facing thanks to Essure permanent birth control. The controversial device, which has been pulled from sale in numerous parts of the world, is comprised of polyethelene terephthalate (PET) fibers surrounded by an outer coil made of nickel titanium. Once implanted in the fallopian tubes, the PET fibers irritate the surrounding area, creating scar tissue formation that prevents the woman’s eggs from being fertilized.

But while the reaction triggered by the PET fibers is by design, the nickel used in the outer coil may be a serious concern for those with sensitivity to the metal.

Understanding Nickel Allergies

Reports of nickel allergies have been on the rise in recent years, largely due to the increasing popularity of electronic devices like smartphones, tablets, and fitness trackers. The Centers for Disease Control and Prevention estimate that anywhere from 10 to 20 percent of the population is allergic to nickel.

As with most allergies, nickel allergies occur due to the body’s immune system detecting a substance that it registers as a harmful, foreign threat. Once the immune system registers a threat from a particular allergen, it will always be sensitive to it and produce an allergic reaction. Researchers believe that sensitivity to nickel may be genetic.

Depending on the person, nickel allergies may occur after first exposure, or after repeated and prolonged exposure. This means that people could be allergic to nickel without realizing it, even if they regularly have brief interactions with the metal.

Nickel is by no means a rare metal, and it’s found in everything from jewelry to coins. However, since symptoms can take time to manifest, days in some cases, it’s possible for a nickel allergy to go undiagnosed.

Nickel Allergies and Essure

Because Essure is designed to be a permanent birth control device, patients implanted with Essure will be permanently exposed to the nickel coil. Not only is there a risk of triggering an existing allergy to nickel, but Essure’s official FAQ suggests that patients may develop a nickel allergy once the device has been implanted.

snippet of nickel allergy side effects of Essure

Developing an allergy to nickel and other metals is also specifically referenced in the FDA’s Essure patient checklist that is provided to doctors.

Snippet of FDA guidance on Essure nickel allergies

However, it’s worth noting that this FDA guidance was added long after Essure entered the market, and providing the patient with the checklist explaining the risks isn’t mandatory for doctors.

Without a reliable way to predict if patients will develop an allergy to nickel – even through conventional allergy testing – permanently introducing a highly allergic metal into the body is one of the many reasons Essure has come under fire. Thousands of women have filed complaints with the FDA over complications with Essure, for reasons that go well beyond nickel allergies.

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