NHS Medical Director, Sir Bruce Keogh’s report into the PIP situation has been issued today by the Department of Health. The report is damning of the devices, claiming they fail by rupture or leak at a rate 2-6 times that of other implants, but concludes that there is no evidence of any toxic risk from the silicone.
The PIP scandal has been our most frequently referenced news event of the past six months, and Sir Bruce Keogh’s report has been much anticipated as it was intended to draw a line under the UK Department of Health’s deliberations about what to do next. It’s a thorough going-over of the subject, but doesn’t contain any real surprises.
You can read the full report here.
Available evidence on PIP breast implants, including the results of additional studies commissioned since the Department of Health’s interim report in January concludes that there is no evidence of a chemical or toxicological risk to human health and that the consistency of these findings across the world suggest that conclusion isn’t about to change. Secondly PIP rupture rate is higher than other implants and detectable in the first five years. Thirdly some failures do provoke tissue reactions which are easily detected by outward clinical signs, making so-called “silent” ruptures not of concern.
So the report’s main conclusions relate to the treatment of implantees, this being the area of most contention among the population. Sir Bruce states that while the implants are clearly substandard, the there is no evidence of a significant increased risk of clinical problems in the absence of rupture, this “you’d know if you had problems” principle underlying the recommendations for treatment.
The report goes on to reiterate (indeed it says “amplify”) the advice previously given, namely that the original provider should contact all women to offer a consultation and “appropriate investigation. If the original provider has not done this, or won’t, or no longer exists, then the patient’s GP will arrange a referral to an appropriate specialist who should offer her the option of explantation if there is any sign of rupture. If there is no sign of rupture the report helpfully provides a list of seven considerations to help the patient decide what to do next. One option at this point is explantation, which the NHS will support if the original provider refuses to do so. The NHS continues to state that it won’t “normally” replace explanted PIPs. That suggests there may be circumstances under which it will perform a replacement.
Finally, if a woman decides against an explantation she is advised to have annual follow-ups and be aware of any of the physical signs that the implant may have ruptured, the first of which should be followed by explantation.
So, no real changes to the original advice, which is perhaps reassuring for victims of this debacle, and at very least suggests that the early judgement arrived at by the Department of Health late last year were the right ones.
It would be interesting to know how many of the original providers are still not playing ball however.
Source: Department of Health