This comment discusses the requirements, challenges and limitations for setting up medical device registries for breast implants. Previous experiences, notably the PIP implant scandal in 2010, revealed the inaccuracy and inefficiency of the majority of breast registers in place, and resulted in a rethinking of how registries should work. Quality registries monitor the three Ps: person (eg. patient, surgeon), part (eg. device) and place (eg. hospital). Setting up a register requires a minimum agreed dataset and clearly defined endpoints (eg. revision) of a permanently implanted medical device (eg. breast implant) by means of a medical intervention (operation) readily recorded in a routine procedure, where a direct causal and logical relationship between the malfunction of the device and revision operation exist. Apart from the technical realization, the hurdles for setting up a registry are predominantly found in the political, ethical, financial, and governing spheres. The possible benefits of a working registry for the stakeholders might be evident, and include a market overview (industry), recall mechanism (surgeons, industry, and patients), benchmarking (surgeons, hospitals) legal, quality management (governing body), as well as regulatory control (government). However, the impact of the data accuracy can be limited by the span (eg. national vs. international) of and participation (opt-in vs. opt-out) in a given registry. Future efforts should take into account past experiences and build upon international collaborations to develop optimal solutions for improving patient safety
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