- By Region
British regulators wrote to the French producer of faulty PIP breast implants more than 20 times over seven years before the company was shut down in 2010 and failed to follow up concerns from surgeons, according to a government review released on Monday that cleared them of any mishandling.
Staff at the Medicines and Healthcare Products Regulatory Agency did not initially consider the rate of rupture of the implants over time, said the assessment, which firmly placed responsibility for the “deliberate fraud” on the company.
“In hindsight, knowing what we now know about the practices at PIP, this body of evidence could be seen as suggestive of a problematic manufacturer,” it concluded.
The report, overseen by Earl Howe, parliamentary undersecretary of state at the Department of Health, said the agency should improve records management and “press ahead” with work in future to more systematically analyse reported problems.
It supported calls for the introduction of registers to trace breast implants and other higher-risk medical devices in future; highlighted the need for better communication on matters where there is public concern; and criticised “key strategic posts” being left unfilled for long periods, highlighting that the regulator’s top device post was vacant for 18 months.
It urged creation of a single European system to share problems on medical devices between national bodies, supplemented with regulator teleconferences, and reiterated the view that there was no evidence of additional health risks caused by the implants.