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Latest News | 17 February 2012

UK Regulator: Don’t Overreact to PIP Scandal

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The head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), Kent Woods, said modest improvements are necessary to correct deficiencies exposed during the Poly Implant Prothese [Read More...]

Tags: Britain change Horton Improvements Lansley MHRA PIP Regulatory Scandal Woods
Latest News | 3 February 2012

EC Investigation of PIP Implants Inconclusive, Calls for Further Study

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A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP’s breast [Read More...]

Tags: Breast Implant EC European Commission France French Investigation PIP Poly Implant Prothese report Scandal Study
Latest News | 30 January 2012

After Drug Deaths, Calls for Pakistan to Form Independent Drug Regulatory Authority

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Pakistan is facing calls from industry for a drug regulatory authority to be formed after a batch of cardiac drugs given to patients at a government-run hospital has been linked to more than 100 [Read More...]

Tags: Cardiology Deaths Drugs Pakistan Pharmaceuticals Punjab Scandal
Latest News | 26 January 2012

PIP Executive Arrested in France, Could be Charged With Manslaughter

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Two former executives of the French company Poly Implant Prothese (PIP) were arrested on 24 January by French investigators, who may charge at least one of them with manslaughter for their role in a [Read More...]

Tags: Breast Implant France French Jean-Cloude Mas PIP Poly Implant Prothese Scandal
Latest News | 25 January 2012

MHRA Fires Back at The Lancet, Says Critics Lack "Clear Analysis of the Facts"

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Earlier this month, the British healthcare journal The Lancet published a series of scathing editorials that lambasted the medical device regulatory regimes of a number of European countries, and [Read More...]

Tags: Breast Implant Critics Editorial Lancet medical devices MHRA PIP Richard Horton Scandal The Lancet
Latest News | 19 January 2012

Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate

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As the uproar over the faulty breast implants manufactured by French manufacturer Poly Implant Prothese (PIP) continues to unfold, an unwitting casualty may be the US medical device lobby, which has [Read More...]

Tags: AdvaMed Breast Implant EC EMA FDA MDUFA Medical Device PIP Scandal
Latest News | 12 January 2012

Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations

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United Kingdom Health Secretary Andrew Lansley announced a new initiative aimed at “ensuring the safety of people seeking cosmetic interventions” on 11 January in response to the recent Poly Implant [Read More...]

Tags: Andrew Lansley Breast Implant EMA Guido Rasi medical devices NHS PIP Regulation Scandal UK
Latest News | 6 January 2012

UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices

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European Medicines Agency (EMA) Executive Director Guido Rasi and French Health Minister Xavier Bertrand called on the EU to require medical device makers to go through a more rigorous approvals [Read More...]

Tags: AFSSAPS Breast Implant EMA Europe France MAA medical devices PIP Regulation Scandal
Latest News | 2 January 2012

Reuters Analysis: Breast Implant Scandal Shows Shortfalls of Post-marketing Registries

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The Poly Implant Prothese (PIP) scandal raging across Europe right now highlights the failings of regulatory agencies to effectively use post-marketing registries, claims Reuters journalist Anna [Read More...]

Tags: Breast Implant CDRH FDA France PIP Reuters Scandal William Maisel