Stricter device regulation needed—lessons from the past

Abstract

On June 18, the UK's Department of Health published its final expert report on the safety of Poly Implant Prostheses (PIP) breast implants, which reviewed evidence about the 240 000 implants of this type that have been used in England. Although the report concluded that PIP implants are not toxic or carcinogenic, it nonetheless reported that implants were more likely to rupture. The rupture rate is about double that of other brands of implant—at 6–12% after 5 years and 30% after 10 years. In addition to the substantial concerns for patients and their doctors, these findings show that present regulatory framework for medical devices in the UK does not meet quality criteria.The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and devices work and are acceptably safe. Yet the scandal of PIP implants is not the only indication of weaknesses in the regulatory system for medical devices—failures of metal-on-metal hip implants have been reported extensively in this journal. As discussed in a Lancet Comment, these serious examples of device failures result from MHRA's paralysis and inability to address the shortcomings of a badly flawed system.There is an urgent need for reform of the MHRA. The European Directive on medical devices is not expected to change until 2016. For this reason, the European Parliament and the UK Association of British Healthcare Industries have separately called for the introduction of a system of premarket authorisation for high-risk medical devices and welcomed recommendations to reinforce market surveillance, to give consumers the opportunity to report adverse events.The case of PIP implants illustrates the failure of the regulatory system for medical devices in the UK, and the approval system for medical devices in the European Union (EU). UK and European device regulation should be able to safeguard the health of the public by ensuring that medical devices work and are safe. A major revision of the UK's regulatory environment and better integration into the EU system of regulation for medical devices is urgently needed to restore public trust.For more on the scandal of device regulation in the UK see Comment Lancet 2012; 379: 204 On June 18, the UK's Department of Health published its final expert report on the safety of Poly Implant Prostheses (PIP) breast implants, which reviewed evidence about the 240 000 implants of this type that have been used in England. Although the report concluded that PIP implants are not toxic or carcinogenic, it nonetheless reported that implants were more likely to rupture. The rupture rate is about double that of other brands of implant—at 6–12% after 5 years and 30% after 10 years. In addition to the substantial concerns for patients and their doctors, these findings show that present regulatory framework for medical devices in the UK does not meet quality criteria. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and devices work and are acceptably safe. Yet the scandal of PIP implants is not the only indication of weaknesses in the regulatory system for medical devices—failures of metal-on-metal hip implants have been reported extensively in this journal. As discussed in a Lancet Comment, these serious examples of device failures result from MHRA's paralysis and inability to address the shortcomings of a badly flawed system. There is an urgent need for reform of the MHRA. The European Directive on medical devices is not expected to change until 2016. For this reason, the European Parliament and the UK Association of British Healthcare Industries have separately called for the introduction of a system of premarket authorisation for high-risk medical devices and welcomed recommendations to reinforce market surveillance, to give consumers the opportunity to report adverse events. The case of PIP implants illustrates the failure of the regulatory system for medical devices in the UK, and the approval system for medical devices in the European Union (EU). UK and European device regulation should be able to safeguard the health of the public by ensuring that medical devices work and are safe. A major revision of the UK's regulatory environment and better integration into the EU system of regulation for medical devices is urgently needed to restore public trust. For more on the scandal of device regulation in the UK see Comment Lancet 2012; 379: 204 For more on the scandal of device regulation in the UK see Comment Lancet 2012; 379: 204 For more on the scandal of device regulation in the UK see Comment Lancet 2012; 379: 204