Min­is­ter in warn­ing to watch­dogs over mesh

The Sunday Post (Inverness) - - NEWS -

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.”

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