According to a report from the Commons Health Select Committee, The Department of Health and the Medicines and Healthcare products Regulations Authority (MHRA) showed “a lack of urgency” in making women aware of the risks of the substandard implants and in the investigation into the extent of the problem.
Graeme Swain, specialist medical negligence solicitor said, “The advice so far has been for women not to panic, but new evidence has reported that surgeons are encountering problems in removing ruptured implants. This may mean that women will be recommended to have them removed early.”
MP’s have also called for the Government to allow women to pay to have replacement implants fitted when they have the faulty implants removed to avoid the women having to have two operations in quick succession. Swain & Co maintain that the implants should now be removed and new implants put in totally free of charge.
It is believed that around 47,000 British women have PIP implants, and today’s report raises concerns that “there wasn’t greater vigilance” considering what was known about PIP implants before March 2010 when the European quality assurance mark was withdrawn following the intervention from French medical regulators, who had become concerned over the use of unauthorised industrial silicone. MP’s claim concerns should have also been raised to the fact that the implants were substantially cheaper than competitor products and were not the implant of choice for surgeons.
However, the most serious criticism relates to the time between March 2010 and December 2011 where the Department for Health and the MHRA failed to raise the public’s awareness and failed to gather the necessary information to reach a considered view about appropriate action to be taken. The fact that over 40,000 women were known to have had the PIP implants should have been enough to provoke a high profile policy response sooner, and MP’s say that the communication with women after March 2010 “was inadequate”.
The Government later promised that women who had the PIP implants fitted with the NHS could have them removed and replaced. However, the vast majority of the affected women had their surgery privately. Many of the private clinics are refusing to bear the cost of replacing the implants free of charge when the PIP implants were approved by the MHRA. Whilst women are arguing that they shouldn’t have to bear the cost either, as they trusted that the implants being used were safe and fit for purpose. Clinical negligence claims are being considered by Swain & Co.
There is also much confusion over the matter with the private clinics where women have been asked to pay for scans and obtainment of medical records, whether they are being charged for removal or replacement and what criteria the women must meet to have the implants removed.
This led to minister reluctantly agreeing to women being allowed to have the implants removed on the NHS if there is a medical/clinical need. This report calls for these women to be able to have the option to pay to have the implants replaced in the same operation to avoid having to have two separate operations in quick succession.
Two points of concern here is the fact that evidence is suggesting that the removal of the ruptured implants is much more complicated than estimated, and this may mean that the advice shifts to having the implants removed before a clinical/medical needs arise. Plus the issue of fault, which the report indicates is the MHRA, as they approved implant, the NHS and private clinics alike fitted them as they were completely legal and MHRA approved.
The debate will rage on, and here at Swain & Co we eagerly await the results of the two reviews being conducted: Lord Howe, the Health minister is investigating whether the Department of Health and MHRA took the appropriate action, while Sir Bruce Keogh, the NHS medical director, will be looking into the need for stricter regulation of plastic surgery.
We hope that the MP’s call for the removal and replacement of PIP implants simultaneously, provides women with some reassurance. But, we are here to offer advice with clinical and medical negligence concerns. Call Graeme Swain or Tina Smith on 02392 483322 or Melanie Lidstone-Land on 02380 631111.