After months of fallout from news that thousands of women across Europe and around the world had received silicone breast implants made with substandard materials, the British government has released a review of how its own regulators behaved in approving the implants in the first place. Their conclusion: Regulation couldn't have prevented everything, but tighter scrutiny would have helped.
Reuters reported on the U.K. government's review of its Medicines and Healthcare products Regulatory Agency (MHRA). The government's main conclusion, moving forward, focuses on urging the MHRA to be much more meticulous in the data it considers before approving an implant.
"The MHRA needs to look at how it gathers evidence so it is able to identify problems early," Reuters quotes health minister Lord Howe as saying. "It needs to better analyze reports about higher risk medical devices. And it needs to improve the way it communicates with the public." Particularly, government officials want U.K. regulators to seek more detailed clinical evidence from a wider selection of sources, according to the article.
Naturally, the agency's head, Kent Woods, said the MHRA would move quickly to enact the recommendations and improve how it regulates medical devices in particular, according to the story. And more regulation is likely: A second government review is looking at possible moves, such as a breast implant registry, so problems can be monitored, Reuters notes.
Britain's regulatory system for medical devices has faced a firestorm because of Poly Implant Prothese (PIP), a now-defunct French company that disclosed countless women had received breast implants made from substandard materials for years. More than 400,000 of the implants were sold globally and about 40,000 women in Britain alone have been identified as PIP implant recipients. Meanwhile, European Union officials continue to pursue greater regulatory oversight for implants as a result of the controversy, and the FDA has subsequently been critical of the region's regulatory approval process for being relatively lax.
- read the Reuters story