Minister in warning to watchdogs over mesh
Health Secretary Jeane Freeman has warned medical regulators she will take action over the mesh crisis if they fail to prove devices are safe.
She has written to the Medicines Healthcare Regulatory Agency making clear her “dismay and concern” over reports devices were “approved on the flimsiest evidence”.
The Cabinet Secretary has asked the agency to explain itself over “inferences” in the British Medical Journal that the “organisation has not managed the regulation of this class of medical devices with sufficient rigour”.
In a searing letter, she also asks them to respond to claims regulators let manufacturers “off the hook”.
New regulations are on the way, but she told the agency: “I remain deeply concerned patients are being let down by this lack of thorough analysis of these devices being marked in the UK.”
On hernia mesh, she said: “On becoming aware of the concerns of patients who have complications from the use of mesh to repair their hernias, I wrote to the MHRA asking it for evidence that this mesh is safe to use in such procedures.
“If I cannot be satisfied that there are robust processes which ensure that this is safe, I will not hesitate to take appropriate action.”