In the words of the recently deceased, late great Etta James, “At Last”. UK’s competent authority the MHRA, ultimately responsible for implementation of device regulations in its jurisdiction has finally issued a retort to The Lancet’s inflammatory article of last week. The response can be found here.
The Lancet’s article revolved around the PIP breast implant scandal and was damning of MHRA’s role in ensuring adequate warning was provided and general information supplied to concerned clinicians and patients. At the time we’ll admit we too found the article to be misleading and riddled with non sequiturs, especially in the way it applies the PIP problem across all medical device issues, when it clearly a most unusual act of deception. Indeed we referred to some of The Lancet’s contentions on January 13th here.
So what is MHRA saying?
- It issued advice the implants should not be used as soon as they established the filling was non compliant
- It confirmed that the new silicone filling was not genotoxic nor chemically toxic
- It does not believe that there is clear evidence of higher rupture rates than normal in PIP implants
- It acknowledges that changes to regulatory rules are necessary and in train, not least regarding improved oversight of notified bodies, surveillance of post-market events and collaboration between national regulatory bodies.
- It accuses The Lancet of not clearly analysing the facts.
- It concludes that the actions of PIP were “deliberate, economically motivated breaches of regulatory requirements” and questions whether “any feasible regulatory reform could adequately guard against such incidents.
We broadly agree and can see little good coming from any knee jerk reaction to what is clearly a deliberate act to mislead. We do however question whether the introduction of measures such as unannounced spot checks would be helpful, together with a statement of the agency’s position on the perceived conflict of interest for Notified Bodies.
Source: MHRA, medlatest staff