Women who are allergic to nickel can have severe inflammatory reactions to Essure, including chronic pain and autoimmune diseases.
Essure Allergic Reactions
Essure is a 4-cm insert that consists of a nickel-titanium (Nitinol) outer coil and a stainless-steel inner coil wrapped in polyester fibers. When expanded, the nickel coil pushes against the wall of the fallopian tube.
Unfortunately, there is no way to predict who will develop allergies to an implant like Essure — even skin-tests are unreliable. Most women who suffer an allergic reaction to Essure are forced to have the coils removed through a surgical hysterectomy.
What is a Nickel Allergy?
It is estimated that 10-25% of all women in the United States have a nickel allergy. Most cases involve skin rashes (allergic contact dermatitis), but an allergy can also occur through internal contact.
FDA Reviews Hundreds of Reports of Allergic Reactions to Essure
Between November 2002 (when Essure was approved) and May 2015, the FDA received 878 reports of allergic reactions or hypersensitivity to Essure. Of these, 212 reports involve women who had Essure surgically removed at least in part due to the allergic reaction.
According to the FDA report (PDF):
“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.”
Essure Nickel Allergy and Chronic Pain
Hundreds of women have experienced chronic pain after receiving Essure. The FDA warns that nickel allergy with or without local inflammation is a possible cause of abdominal and pelvic pain.
Nickel Allergy Warnings Removed from Label
The original label for Essure recommended that doctors perform a skin-test on women to check if they had a nickel allergy. In 2011, the FDA removed this recommendation after Conceptus argued that the tiny amount of nickel in Essure would only cause side effects in 1-in-10,000 of patients. Click here to read more.
Warnings Signs & Symptoms
Symptoms of an allergic reaction to nickel may include:
- Rash or bumps
- Itching (may be severe)
- Redness or changes in skin color
- Eczema (skin lesions)
Non-Skin Allergic Reactions to Nickel
According to the FDA, some studies suggest that non-skin allergic reactions could be associated with nickel hypersensitivity, including:
- Chest pain
- Migraine headaches
- Heart palpitations
- Edema (swelling)
- Respiratory problems
- Digestive symptoms
- Increased symptoms of asthma