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U.K. Health Dept. Recommends Stronger Adverse Event Reporting System In Wake Of Breast Implant Scandal

Internal review finds U.K. regulators were not at fault in the PIP breast implant scandal, but recommends improvements to adverse event reporting and analysis.

A review into whether the U.K. Medicines and Healthcare products Regulatory Agency and the Department of Health could have prevented or alleviated the scandal involving Poly Implants Prostheses SA’s silicone-gel breast implants determined that neither the regulator nor the U.K. government acted inappropriately before or after information about the defective implants was revealed. However, the report recommends improvements in how MHRA learns about, reviews and responds to harmful incidents.

The U.K. health department report, released May 14, lists 15 recommendations targeted at increasing adverse event reporting by health care providers, strengthening MHRA's methods and processes for analyzing adverse events,...

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