The Facts About Medical Device Safety: a Message from Our Chairman and CEO, Mike Mahoney

To our stakeholders,

Currently, there are news reports questioning the safety and integrity of the medical device industry. These critiques are concerning and misleading, and without sufficient context could discourage individuals from seeking the care they need from a physician. It is important to have balanced information when making any healthcare decision, and I’d like to share my perspective as well as facts about the safety and quality of Boston Scientific devices.

Patient safety always comes first

All of us at Boston Scientific work here because we are passionate about advancing science and helping patients. We hold ourselves, and each other, accountable to extremely high standards because we know that our products have the power to change lives. This is a tremendous responsibility, and we take it very seriously. We know that any one of us, our family members or friends could become a patient or caregiver at a moment’s notice – and many already are.

We invest approximately one billion dollars annually in research and development to address unmet patient needs through innovative medical technologies, including therapies for some of the most complicated, debilitating and life-threatening conditions.

While we can’t completely eliminate risk when complex technologies and patient conditions are involved, we aim to have the lowest possible rate of adverse events associated with our products, and never stop working to further improve the safety and effectiveness of our devices.

We have a stringent internal monitoring and auditing system to ensure our devices are routinely assessed, and we comply with the standards of the U.S. Food & Drug Administration (FDA), CE Mark and regulators in all countries where our products are offered. We thoroughly investigate all complaint reports, and if an error or problem is detected, we work closely with regulators and promptly notify physicians. Our real-world performance monitoring for our products in all of the countries where they are sold demonstrates an average annual complaint rate across our entire product range of less than 0.15%, and an even lower rate of adverse events.

Operating with integrity & transparency

Significant unmet needs for patient-centered innovation remain, and the biggest advances are made through collaboration between clinicians, researchers, care providers, patients, regulators and industry. At Boston Scientific, we feel it is critical for our company’s collaboration with physicians to be ethical, patient-focused and transparent. We have rigorous internal controls to ensure that physician funding meets strict criteria for serving an educational need or advancing innovation. Additionally, all our employees have a responsibility to act with integrity as stipulated in our Code of Conduct and MedTech Europe Code of Ethical Business Practice. You can read more about our safety and transparency standards here.

It is important not to let fear and misinformation stand in the way of progress. Please find additional resources on this website and know that we are here to address any questions you have about our products or our safety and compliance processes.


Mike Mahoney
Chairman and Chief Executive Officer, Boston Scientific