Regulatory Focus™ > News Articles > Investigation Clears Faulty Implants of Most Serious Safety Concerns

Investigation Clears Faulty Implants of Most Serious Safety Concerns

Posted 18 June 2012 | By Alexander Gaffney, RAC 

The UK's Department of Health (DoH) has released its second and final report on the role of regulatory authorities in the proliferation of defective breast implant products manufactured by the now-shuttered French medical device manufacturer Poly Implant Prothese (PIP).

The review, announced in January 2012 by UK Health Secretary Andrew Lansley, was aimed at "ensuring the safety of people seeking cosmetic interventions" after French authorities discovered PIP had sold breast implant products containing unapproved industrial-grade silicone rather than the medical-grade silicone approved for use in humans.

Further concerns were raised by regulators after some indications showed higher-than-average revision rates for the implants, and many authorities have recommended consumers implanted with the devices have them removed.

An initial review of the Medicines and Healthcare products Regulatory Agency's (MHRA) response to the crisis was released by the NHS in May 2012, and the report recommended a number of improvements to the agency, including better communication, better data tracking measures and more routine reviews of public information to identify risky products.

The NHS' final report, the result of an investigation lead by NHS Medical Director Sir Bruce Keogh, takes at least some of the pressure off of MHRA for its failure to identify PIP's "deliberate fraud."

Keogh's evaluation found nothing indicating the implants would cause a "long-term threat to human health," though the rupture rate of the devices is up to two times higher than similar approved devices. The investigation's findings that implant ruptures are not found to be associated with cancer or other toxic responses is likely to be particularly reassuring to patients after fears were raised about the effects of the industrial grade silicone on the human body. Keogh's investigation found most of the silicone, while not of the appropriate grade, was nevertheless used in many other consumer cosmetic products and "does not present a health risk" to patients.

"Repeated tests on different batches of PIP implants have been carried out in the UK, France and Australia according to international standards," said Keogh. "Those tests have shown that the implants are not toxic and therefore we do not believe they are a threat to the long-term health of women who have PIP implants."

"I sincerely hope this helps to reassure women that their long term health is not at risk."

Read more:

DOH - Final expert report on PIP breast implants published


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