The U.K. regulators who should have been there to protect the health of patients, fell down on the job when it came to the silicone breast implants made with substandard materials, received by thousands of women, according to a government review published Monday.
The Poly Implant Prothese (PIP) case involved deliberate fraud, so oversight alone wasn't going to prevent the problem, the U.K. health minister acknowledged, but he said the agency could have done more, Reuters reports.
The now-defunct French company disclosed that countless women had received breast implants made from substandard materials for years. Agencies around Europe that inspected the company's manufacturing operations have also been taking heat for not discovering the problems before the implants began to rupture, putting women's health at risk. 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.
The FDA in 2000, raised questions about PIP's manufacturing operations and sent the company a warning letter after an inspection noted manufacturing shortfalls. The company had been selling saline implants in the U.S. for four years by then, but not the silicone implants because at the time the U.S. was not allowing use of silicone. But FDA concerns over the manufacturing practices apparently didn't make it into the records of foreign regulators. Maybe they should have.
According to Reuters, the main conclusion of the U.K. review of the Medicines and Healthcare products Regulatory Agency (MHRA), is that it needs 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.
The agency's head, Kent Woods, assured the public that the MHRA will 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.
- read the Reuters story
- get more from Reuters on FDA oversight