Study design, materials and methods
We reviewed records of 3 patients who underwent implantation of a sacral neuromodulation device for urinary dysfunction and developed allergic reactions to the device among over 180 patients who under SNM for different reasons.
Collection of data of these 3 patients included demographics, indication, time to first symptoms, reaction duration, severity, treatment methods, and response to treatment was performed.
Results
The patients included:
First patient, a 67-year-old Caucasian man who developed generalized itching after implanting SNM device. He had a successful stage 1 with excellent urinary results. However, itching symptoms progressed into a whole-body rash with hives over the course of 2 weeks. Locally, wound was not healing properly. There were no symptoms or signs of infections. He was failed treatment with hydroxyzine, fenofexadine, and diphenhydramine. He was referred to an allergist who revealed a nickel allergy. This was confirmed with the manufacturer to be involved in the alloy. The device ultimately had to be removed and all symptoms resolved once removed.
The second patient is a 63-year-old Middle Eastern female who developed itching and whole-body petechial rash after 2 weeks of implanting the device. There were no symptoms or signs of infection. She had excellent control of her urinary symptoms and wanted to keep her device. She was treated successfully with increasing doses hydroxyzine and fexofenadine with the assistant of allergy specialist. Her allergic symptoms were finally controlled, and she opted from removal of the device. She is currently on low dose of hydroxyzine.
A third patient was a 50-year-old African American female who developed wheels and well-circumscribed rashes on her shoulders, thighs, and buttocks on post-operative day 1. An allergist revealed an allergy to polyurethane. Her symptoms were well controlled, and she rejected the idea of removal of SNM. She was treated with an initial steroid taper with some success. She was then able to have stable symptoms on high dose of hydroxyzine and fenofexadine. Then we continued with fenofexadine to keep her allergic reaction controlled.
All these patients were treated by SNM for retention of urine with excellent outcomes.
Interpretation of results
Sacral neuromodulator devices although rare but may be associated with allergic reaction. While over-the-counter antihistamines may be successful in treating milder symptoms, moderate and severe reactions may require stronger anti-allergic medication and steroids taper may be necessary. Treatment of allergic reactions may be feasible if controlled with anti-allergic medications and removal of the device may be unnecessary. Persistent symptoms may require team approach with allergists to help to control the symptoms and identify the metal responsible for the problem.