Alert | Implant Quality Lapses Fuel Push for . . .
Implant Quality Lapses Fuel Push for More Devicemaker Data; Learn What's Under Consideration
While judging the Medicines and Healthcare products Regulatory Agency's (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH) finds the agency needs better access to information on devices to preclude similar safety scares in the future.
The MHRA “fulfilled its obligations” in pursuing French devicemaker Poly Implant Prosthese about incidents involving its product and sought to determine the cause and extent of the problems being reported, the review states. “However, it is also clear that these investigations were hampered by a lack of reliable and comprehensive information about all the adverse incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products,” Earl Howe, parliamentary under-secretary of state for quality in the DOH, writes.
The agency should review the way it manages device records so they can be retrieved and analyzed more easily, the Howe review recommends.
Among other measures, the review calls for the MHRA to enhance its communications capability to ensure the timeliness of device alerts and improve its periodic trend analysis of data on adverse events, including more systematic analysis of the relation between reported incidents and sales. It also calls for all EU countries to work more closely together and share information about devices within the existing regulatory framework.
Need for Single EU Reporting Portal
“In particular, [the MHRA and UK government] should press for early adoption of proposals for a single European reporting portal to provide a central repository for information on device adverse incidents,” the report states. It adds that the MHRA should press for more frequent teleconferences to facilitate discussions regarding medical device safety and regulation.
Still, nothing about the PIP scandal suggests the current system for regulating devices is “fundamentally unsound” or that a shift is needed toward a U.S.-like device regulatory framework or one modeled on the EU's medicines regulations, the review concludes.
The review comes after more than 300,000 PIP implants were sold in more than 65 countries between 2001 and April 2010, when they were recalled by the now defunct manufacturer. The devices, made using industrial-grade silicone, have been associated with a high rupture rate, among other safety concerns.
In December 2011, the French Ministry of Health recommended that all women with PIP implants should have them removed. By contrast, the MHRA concluded that a lack of evidence the devices increase the risk of cancer or have a disproportionate rupture rate compared with other breast implants didn't warrant routine removal.
Testing by Australia's Therapeutic Goods Administration also didn't identify a specific serious safety concern with PIP implants, according to a review released May 18. “The information we have cannot confirm or exclude this possibility, but the number of reported ruptures in Australia to date is within an expected range,” the review states. — June 2012