Hundreds of women have been seriously injured by allergic reactions or hypersensitivity to nickel in Essure. Some of these women have experienced chronic pain, inflammation, skin rashes, or needed surgery to remove Essure.
What is a Nickel Allergy?
An estimated 10-25% of women in the United States are allergic to nickel. Most cases involve an itchy skin rash known as allergic contact dermatitis. Internal contact with medical devices like Essure can also cause allergic reactions.
Nickel Allergy from Essure
The Essure micro-insert consists of two metal coils, one made of nickel-titanium (Nitinol) and one made of stainless steel. Once implanted in a woman’s fallopian tube, the nickel coil presses against the sides of the fallopian tubes and helps anchor Essure in place.
What is the problem?
There is no reliable way to tell who will have an allergic reaction to Essure. Unfortunately, women who experience this side effect (with or without local inflammation) can develop chronic pain. They may also need to undergo a surgical hysterectomy to remove Essure.
Skin-Test Recommendations Removed from Essure Label
When Essure was approved, the FDA recommended a skin-test to check patients for nickel allergies. In 2011, Conceptus claimed the side effect would only harm 0.01% of all patients and convinced the FDA to remove the recommendation.
Nickel Allergy / Hypersensitivity Symptoms
- Rash or bumps
- Itching (may be severe)
- Redness or changes in skin color
- Eczema (skin lesions)
Non-Skin Symptoms of Nickel Allergy
Hypersensitivity reactions to nickel are associated with a wide range of systemic side effects, according to recent studies. The FDA warns about the following risks:
- Chest pain
- Migraine headaches
- Heart palpitations
- Edema (swelling)
- Respiratory problems
- Digestive symptoms
- Increased symptoms of asthma
FDA Reviews Over 800 Reports of Essure Allergic Reactions
In September 2015, the FDA published a report (PDF) on adverse events linked to Essure between November 2002 and May 2015.
These reports included 878 cases of allergic reactions or hypersensitivity linked to Essure. At least 212 women had surgery to remove Essure at least partly due to the reaction. According to the FDA:
“A handful of case reports in the medical literature have noted individuals who developed a rash following placement (as early as 3 days), subsequent positive patch test results, and timely resolution of the rash following device removal, all of which are suggestive of a traditional hypersensitivity reaction.”