Device regulator is told to improve its safety monitoring after breast implant debacleBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e3456 (Published 15 May 2012) Cite this as: BMJ 2012;344:e3456
- Ingrid Torjesen
A government review has concluded that the UK regulator of medical devices, the Medicines and Healthcare Products Regulatory Agency (MHRA), acted “reasonably” in communicating to the public safety issues related to breast implants made by the French company Poly Implant Prothèse (PIP).
The review was ordered by the health secretary for England, Andrew Lansley, in January, when it became clear that more than 40 000 UK women had been fitted with the defective implants, which had fraudulently been filled with non-medical grade silicone.1
Although the review, conducted by the health minister Earl Howe, exonerates the actions of the MHRA and the Department of Health, it says that both organisations need to learn lessons, particularly in how to communicate information promptly and appropriately to affected individuals, the medical profession, the public, and the press.2
Although the MHRA was found to have …