PIP implants response from government was 'inadequate'

PiP implants
The MHRA have also been criticised for their response to the scandal Photo: Reuters

The government and a health regulator have been criticised for their "inadequate" communication with women over the PIP breast implants scandal, MPs said.

A near-21-month delay between a safety alert being issued to surgeons over the potentially faulty implants and "urgent action" to gather evidence and communicate with victims, was pointed out by the Commons Health Committee.

Around 47,000 British women are believed to have been given the implants manufactured by French company Poly Implant Prothese (PIP).

PIP implants
Thousands of British women have been affected by PIP implants Credit: REUTERS/Eric Gaillard

The report also outlined new evidence that showed the health implications for some women:

  • Surgeons are experiencing "increased difficulty" in removing ruptured implants, which may mean there is a need to take them out early.
  • One of the clinics says women are suffering "redness and lumpy, granular tissue".
  • Even when implants have not ruptured, surgeons taking them out have found a "milky secretion" in 20% to 25% of cases

MPs questioned the actions of both the government and Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA issued an alert in March 2010 telling surgeons they should stop using PIP implants following concerns raised in France.

Such alerts require the NHS to respond saying they will not use the devices, but no such response is required from private clinics, who used the vast majority of PIP implants.

PIP implants
Private clinics used a majority of the PIP implants Credit: REUTERS/Eric Gaillard

The report said no awareness campaign was made to trace affected women, while the Committee heard from the MHRA's head, Sir Kent Woods, that while he could not guarantee private firms had not continued using the implants, he "sincerely hoped" this had not happened.

The action taken to communicate with affected women after March 2010 was inadequate.

The Committee recognises that private clinics had a duty to contact their patients directly, but the MHRA and the Department of Health also had a duty to raise public awareness."

– Commons Health Committee report

The report added that it was "surprising" that urgent action to gather evidence and communicate with women only gathered pace in December 2011, when the French government recommended women have the implants removed.

Given the fact that 40,000 women were known to have received sub-standard implants, the very scale of the problem alone should have provoked a high-profile policy response much sooner, including urgent action to gather evidence that would allow the risks of these implants to be properly assessed."

– Commons Health Committee report

MPs agreed with the government that women who had implants on the NHS can have them removed and replaced and added that those who had them privately could have them removed by the health service if there was a clinical need.

However, they said the Department of Health should consider allowing these women to pay for new implants to be inserted if that is their desire.

Science and Medical Editor Lawrence McGinty looks at the latest suggestions from MPs about how PIP patients should be dealt with by the NHS.