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Latest News | 15 May 2012

MHRA Working to ‘Quickly Implement’ Recommendations from Commission

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The UK’s Medicines and Healthcare product Regulatory Agency (MHRA) said it is moving to act on recommendations made by a Commission in the aftermath of a scandal involving breast implant products made [Read More...]

Tags: Breast Implant Howe Implant Improvement Keough Lansley MHRA NHS PIP report Review UK
Latest News | 14 May 2012

UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements

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The UK’s Department of Health (DOH) has released the result of a review into the Poly Implant Prothese (PIP) Scandal, finding the Medicines and Healthcare product Regulatory Agency (MHRA) to have [Read More...]

Tags: Breast Implant Howe Implant Improvement Keough Lansley MHRA NHS PIP report Review UK
Regulatory Update | 7 May 2012

China Signs MOU with the Netherlands

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China’s State Food and Drug Administration has further expanded its international collaborative efforts in regulatory matters by concluding a Memorandum of Understanding (MOU) with the Ministry of [Read More...]

Tags: breast implants China MOU Netherlands PIP
Latest News | 27 April 2012

Industry Pans EU Plan to Implement Medical Device Registry

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One of the medical device industry’s biggest organizations is sounding off against a plan by the European Parliament to implement postmarketing medical device implant registry system that aims to [Read More...]

Tags: EMA EP Eucomed Europe European Parliament Medical Device metal-on-metal PIP
Latest News | 27 April 2012

EU Looks to Tighten Medical Device Safety With Implant Registry

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The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports [Read More...]

Tags: EC EMA EP Europe Implant Medical Device Parliament PIP Postmarketing Registry Regulatory Safety Tracking
Regulatory Update | 23 April 2012

Brazil: House Holds Hearing on Breast Implants

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The Commission on Social Security and Family of the House of Representatives held on 19 April 2012 a public hearing to discuss the situation of Brazilian women with silicone breast implants made by [Read More...]

Tags: Anvisa Brazil Breast Implant Commission of Social Security and Family Medical Device PIP Rofil
Latest News | 23 March 2012

Brazil’s Anvisa Introduces Additional Controls on Breast Implant Products

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Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global [Read More...]

Tags: Anvisa Brazil Breast Implant Certification Implant Inmetro National Quality Control Instute PIP South America
Latest News | 19 March 2012

Dutch Regulatory Authority Echoes Warning on Faulty Breast Implant Products

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The Dutch Health Ministry is warning thousands of women about the risks associated with breast implant products manufactured by French firm Poly Implant Prothese (PIP) after becoming concerned about [Read More...]

Tags: Breast Implant Dutch Health Ministry Medical Device Netherlands PIP Rupture
Latest News | 9 March 2012

Amidst European PIP Scandal, FDA Approves New Breast Implant Product

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The US Food and Drug Administration (FDA) approved Sientra, Inc.’s breast implant product on 9 March, making Sientra the third approved marketer for breast implant products in the US.The approval [Read More...]

Tags: Breast Augmentation Breast Implant CDRH Cosmetic FDA Implant PIP SIentra
Latest News | 28 February 2012

MHRA: Patients With Metal-on-Metal Hips Need Extensive Monitoring

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The Medicines and Healthcare products Regulatory Agency (MHRA) issued advice to patients and surgeons urging them to monitor so-called metal-on-metal hip replacements on an annual basis for the [Read More...]

Tags: hip Hip Implants metal-on-metal MHRA Patients PIP Surgeons Woods
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