The most important knowledge in the field of patient safety is how to prevent harm to patients during treatment and care. The fundamental role of patient safety reporting systems is to enhance patient’s safety by learning from failures of the health-care providers and system. If these failures are not reported–or if serious side effects after medical interventions are not reported–physicians all over the world will repeat the same mistakes. Therefore, publishing adverse events of a certain treatment is one form of safety reporting system. From critical incidence reporting systems (CIRS), we know that most problems are not just a series of random, unconnected on-off events, but are provoked by weak systems and often have common root causes, which can be generalized and corrected [1]. Although each event is unique, there are likely to be similarities and patterns in sources of risk that may otherwise go unnoticed if incidents are not reported and analyzed. Ultimately, it is the action we take in response to reporting–not reporting itself–that leads to change. Only few serious adverse events after the treatment using bulking agents for urinary incontinence are reported; by the way, there is a similar number of medlined papers on serious vaginal trauma in jet-skiers. Does this mean that we can neglect these side effects because there are so few? Only five papers deal with serious vaginal trauma in jetskiers, but estimating the number of people who do jet ski, there must be a couple of more accidents than those that are reported. It might be similar for serious side effects of bulking agents. We probably dislike reporting complications and negative findings–in sports, because it is meant to be a fun activity, in medicine because we want to offer successful treatments to patients who expect to have their condition improved. Bulking agents have been approved by the Food and Drug Administration (FDA) for use in women with intrinsic sphincter deficiency and are generally seen as the most minimally invasive surgical intervention with few side effects [2]. Due to its minimal invasiveness, some authors do not even consider this treatment as surgical but as belonging to conservative treatment. From our own experience, we know that the smaller the intervention is, the less preoperative information is usually given to the patient. Bulking agents have also been used off-label for the treatment of stress urinary incontinence in men, especially after radical retropubic prostatectomy in which incontinence varies from 2.5% to 87% [3, 4]. A recent publication reports a 41% urethral erosion rate in men who were injected with ethylene vinyl alcohol [5]. One patient suffered from extreme dysuria, urgency, and frequency and required multiple follow-up visits and cystoscopic removal of the extruded material. Urethral erosion of permanent injectable material is a scary condition and may result in a drainpipe urethra with concomitant recurrent infections, as well as deteriorating incontinence, which then is difficult to treat. In another study using the samematerial for the treatment of intrinsic sphincter deficiency in women, the same group reported a 37% erosion rate in 19 patients, with 4 suffering from extreme pain and dysuria and finally 1 requiring repeat cystoscopy to remove the eroding material [6]. Int Urogynecol J (2008) 19:1037–1038 DOI 10.1007/s00192-008-0672-1
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Jan 27, 2019
Dominic Lee + 1
Open Access