The Mandatory German Breast Implant Registry Law: A Model for Sustainable Implant Registries.

BACKGROUND

Recurrent scandals involving breast implants have revealed that scientific evidence on the performance of these devices is lacking, and passive monitoring systems are not capable of detecting problems at an early stage. The German health authorities therefore decided to implement a prospective, mandatory registry.

OBJECTIVES

The aim of this article was to provide information about the advantages of implementing a mandatory registry, the potential hurdles involved, and to establish structural requirements that future registries can use.

METHODS

Since 2018, the authors have assisted the German Ministry of Health in refining the Implant Law and its implementation. They adapted an internationally consented dataset, promoted international data amplification and conducted monthly trial inputs for over 2 years. By identifying several key issues they were able to assist in developing solutions.

RESULTS

The cooperation with the authorities was characterized by appreciation of the authors' expertise and previous international work. Challenges included data privacy issues, federal competence, longitudinal follow-up, and contact data; as well as associated costs and technical solutions for data inclusion and the use of information technology to communicate with stakeholders. Addressing these challenges required considerable interference with personal rights and complementary measures for all stakeholders. Extensive structural precautions were taken to safeguard personal data privacy as far as possible.

CONCLUSIONS

The authors' experience and lessons learned can guide registries seeking to engage in high levels of evidence data. The authors describe their approach, the obstacles they encountered, and the strategies employed to overcome the setbacks of other registries.