Following the latest news that there is to be a government review of the French Poly Implant Prothese (PIP) implants Consultant Breast Surgeon, Professor Kefah Mokbel who specialises in mastectomy and breast reconstructive surgery following breast cancer, has released the following statement to totalhealth:
Although Poly Implant Prothese (PIP) implants were approved in the EU (CE marked), the Food and Drug Administration (FDA) of the USA rejected the company's application for approval due to the lack of adequate data regarding the safety of the implants and the identification of several manufacturing flaws in the process of producing PIP implants.
There is a reasonable body of evidence that PIP implants are more likely to rupture compared with other FDA approved implants. Furthermore, the industrial grade silicone within these implants is more likely to cause tissue irritation and chronic inflammation compared with medical grade silicone.
Therefore, I recommend that women who know that they have PIP implants should consider removal of these implants as soon as convenient (this is not a medical emergency). Magnetic Resonance Imaging (MRI) is the best method to detect external rupture of implants. Ultrasonography is reasonably accurate in identifying a ruptured implant. However, caution should be exercised when undergoing mammography, since the structure of these implants is not adequately strong and can rupture when undergoing compression for mammographic imaging.
There is no evidence that the industrial grade silicone of PIP implants is genotoxic (i.e. causes cancer) according to the Medicines and Healthcare products Regulatory Agency (MHRA). However, the consequences of a prolonged and chronic inflammatory process, secondary to implant rupture, are not clearly established. Chronic inflammation in the breast can lead to harmful consequences and, therefore, prophylactic removal of these implants should be considered.
In order to help those unfortunate women who have PIP implants across the UK, I offer to waive my usual professional fees for removing or replacing the PIP implants over the next six months. However, patients will be responsible for the hospital costs and the anaesthetist’s fees. They will also be responsible for the cost of new implants, should they wish to have the implants replaced.
To arrange a consultation with Professor Kefah Mokbel please click here.
