The long awaited results of testing undertaken by the French medical device regulatory authority, AFSSAPS on recalled PIP breast implants have today been released. AFSSAPS have today confirmed that the results of the latest analysis have found that there is no link between PIP breast implants and genotoxicity (a potential to cause cancer). AFSSAPS have maintained their recommendation that women with PIP breast implants should consult their doctor every 6 months for a clinical examination and an ultrasound of the breast and lymph nodes located under the arm.
The French authorities have further recommended that if an implant rupture or leakage of silicone is suspected, both PIP breast implants should be removed. AFSSAPS advise that because of the complications associated with removing lymph nodes, these should not necessarily be removed due to the possible complications, but, removal should be considered in cases where women are suffering severe reactions as a result of silicone leakage into the lymph nodes.
AFSSAPS have also recommended that when women have their PIP implants removed, they should attend a follow-up appointment within one year of replacement surgery. Due to the possibility of the gel within the implant leaking outside of the shell, Afsaaps do not recommend that ladies with PIP implants breastfeed their children.
In September 2010 AFSSAPS confirmed that interim results of PIP breast implants testing had showed that the gel within the PIP implants was not the same as was described in the manufacturer’s design guide; that it did not reach the level of quality required before a silicone gel can be used in breast implants; that it could lead to an inflammatory reaction in some women and that PIP implants had a higher propensity to rupture. AFSSAPS recommended that all women with PIP implants should be referred for an ultrasound scan and all women with ruptures or suspected ruptures should have both their PIP implants removed. One of the French genotoxicity tests in September was inconclusive and the results of their further testing was not known until today.
The MHRA have yet to release a statement on these latest results. PIP breast implants were the subject of a Medical Device Alert (MDA) by the MHRA on 31 March 2010, ordering a recall on all stocks of the PIP implant. This followed an earlier issue with PIP implants using recalled hydrogel solution in 2006. Many women who were supplied with PIP implants during breast augmentation have experienced agonising problems including ruptures and leakages. Studies last year also found that the manufacturers of PIP breast implants not only dispensed with a protective shell but used an untested gel, said to have been intended for use in mattresses.
Mark Harvey, Partner at Hugh James Solicitors has successfully obtained free breast replacement surgery for some clients with PIP breast implants and is continuing to fight to get compensation for over 350 women for the pain and suffering his clients have suffered as a result of these breast implants.
Reacting to the announce, Hugh James Partner Mr Harvey commented that: “Although our clients will be relieved to hear the results in relation to the gentoxicology results, the AFSSAPS results will still be extremely worrying for our clients. We are now eagerly awaiting a statement from the MHRA; our hope is that they will support the AFSSAPS finding that women with PIP implants should have regular ultrasounds however, we hope that they will go one step further to protect these vulnerable women by making it a requirement that clinics who implanted these faulty devices provide adequate after care for these vulnerable patients.
