30.10.13
‘No evidence’ PIP implants are health threat
There is “no convincing data” to justify the removal of PIP breast implants as a precautionary measure, a new report has found.
The report, published by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), supports the findings of Sir Bruce Keogh’s review into the safety of PIP implants, which was published in June.
The committee found that there is “no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone implant from another manufacturer”.
John Wilkinson, the MHRA’s director of medical devices, said: “The PIP breast implants episode has been very distressing for women and I hope this new report provides reassurance for them.
“The report findings support the scientific conclusions from Professor Sir Bruce Keogh’s independent expert group report that there is no evidence of a long-term threat to human health from PIP breast implants.
“While the PIP episode is believed to be one of deliberate fraud, it has highlighted areas where the current European system of regulation needs strengthening. The MHRA is working with its European partners to ensure that this happens and that patients are protected.”
The abstract from the document is below:
“PIP silicone gel filled breast implants (PIP implants) are reported to have a higher prevalence and incidence of implant ruptures than other silicone breast implants, and that ruptures also tend to occur earlier in the implant life than is the case with other implants.
“These reports indicate that the shell/patch or the manufacturing process for a number of batches of PIP implants was of inferior quality, which may be a reflection of variations in the manufacturing process.
“The risk of implant rupture increases with implantation time. Quantifying the actual increase in failure rate is problematic because the failure rates of non-PIP implants are not well documented.
“Since the previous SCENIHR opinion on PIP breast implants in February 2012 several cyclic siloxanes (known as D4, D5 and D6) have been identified in PIP devices at higher concentrations than in other silicone breast implants. This has led to investigate the possible toxicological consequences of cyclic siloxanes release from damaged PIP implants.
“It became apparent that these chemicals are commonly present in the bodies of women even without breast implants. This is a consequence of the widespread use of siloxanes in many domestic products. Cyclic siloxanes D4, D5 and D6 are non-toxic and not irritant in standard tests.
“In some cases, implant gel-bleed or rupture has been associated with an inflammatory reaction either locally or in regional lymph nodes. In other cases, ruptures were free of symptoms. Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or anaplastic large cell lymphoma.
“While there are differences in rupture rates, there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer.
“In the case of implant rupture, explantation is advised. Because of the widespread concern of undetected ruptures, there is a need for women with PIP breast implants to seek regular clinical examinations, and where deemed appropriate, individual counseling and imaging with ultrasonography or MRI.
“There is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman's condition by her surgeon or other treating physician after consultation.”
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