Regulatory officials at the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have released an interim report looking into an implantable medical device that was recently found to be manufactured using sub-standard and unapproved components.
MHRA regulators have since 2010 been focused on breast implant products manufactured by now-defunct French manufacturer Poly Implant Prothese (PIP), whose products were manufactured with industrial-grade, rather than medical-grade, silicone.
Testing conducted by MHRA in 2010 confirmed the products were not, contrary to fears at the time, genotoxic to patients, though no information was available at the time regarding the rate at which the products were rupturing.
200-600% More Likely to Rupture
After French regulators recommended all patients implanted with the devices have them removed in December 2011, MHRA officials once again established an Expert Group to further assess whether the devices were unsafe for patients.
A mid-year interim analysis published by MHRA on 21 August partially confirmed MHRA's initial fears when it found that the implants are between two and six times more likely to rupture than other implants.
Approximately 1.2% of implants failed within five years of initial implantation, with 3.1% rupturing within 10 years. MHRA cautioned that the, "True underlying failure rate, including 'silent' ruptures, will be greater than [the numbers published]," because many patients would be unaware that their implants had ruptured.
Though the risk of rupture was higher, regulatory officials noted the implants were still not associated with higher risks of other adverse events such as cancer or hematoma. "Analyses of the silicone contained in PIP breast implants indicates that the material does not pose a long-term risk to human health," explained Susanne Ludgate, clinical director of MHRA. "None of the chemicals listed will cause harm at the levels found within PIP breast implants and many are used routinely in various consumer products."
The report comes just as the UK's Department of Health (DOH) prepares to launch its own expert inquiry into how regulators could avoid encountering a similar debacle in the future. Health officials, including those at the National Health Service, had earlier concluded that while PIP's substitution of medical-grade silicone for industrial-grade represented deliberate fraud, regulators nevertheless have ample room for improvement.
The DOH said in a 15 August press announcement that it will be examining the regulatory framework for cosmetic products, including breast implants, with the aim of being able to make concrete recommendations to health officials.