Medical device registries for breast implants - where to?

Abstract

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), (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.

Textured vs. Smooth Breast Implants Using the Jones Criteria—What Is the Currently Available Evidence for BIA-ALCL?: A Systematic Review

“…Successful data collection requires ethical approval and consent processes accounting for an appropriate privacy and legislative framework. In addition, the complexity of the data collection and the associated compliance in international exchange represents a potential barrier [ 22 ].…”

“…Additionally, an unique device identifier (UDI) of the breast implant retracting to the providers, manufacturing procedures, lacks, or malfunctions are needed. Another essential step for the detection of rare diseases is the monitoring of clinical aspects, which includes diagnostic, therapeutic measures, and clinical endpoints [ 22 , 23 ].…”

The power of collaboration

“…7 However, in order to be relevant internationally, there needed to be a minimum dataset with data definitions agreed upon by international plastic surgeon collaborators. 8 With this in mind and with funding from the Australasian Foundation for Plastic Surgery (AFPS), an international collaboration of breast registry activities (ICOBRA) was formed by reaching over geographic boundaries to collaborate with international colleagues. By doing so, we can harmonise datasets, data definitions and outcome measures to facilitate registry data pooling globally.…”