Action by the government and a health regulator to communicate with women over the PiP breast implants scandal was “inadequate”, MPs have said.
The Commons health committee pointed to a more than 20-month delay between a safety alert being issued to surgeons over the potentially faulty implants and “urgent action” to gather evidence and communicate with affected women.
Around 47,000 British women are now believed to have been given the implants manufactured by French company Poly Implant Prothese (PiP).
They were filled with non-medical grade silicone intended for use in mattresses and have been linked to rupture and swelling in the body.
New evidence in the report said surgeons have experienced “increased difficulty” in removing ruptured implants, which may mean there is a need to recommend they are taken out early.
Evidence from one of the clinics also points to women suffering pus, “redness and lumpy, granular tissue”, and silicone in the lymph nodes in “one in four to one in five cases”.
Even when implants have not ruptured, surgeons taking them out have found a “milky secretion” in 20% to 25% of cases, the report said.
MPs criticised the actions of the Medicines and Healthcare products Regulatory Agency (MHRA) and questioned the government’s response.
The MHRA issued an alert in March 2010 telling surgeons they should stop using PiP implants - the CE mark for PiP implants had been withdrawn following concerns raised in France.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.
The report said no awareness campaign was made to trace affected women and 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 report said “sincere hope” is not an adequate basis for regulation.
“There needs to be a more reliable method of communicating Medical Device Alerts to the private sector, that requires a positive response that the instruction has been received and acted upon in the same way as in the NHS,” the report said. “Using the professional associations as channels of communication will not cover all surgeons.”
The report went on: “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.”
The MPs said it was “surprising” that urgent action to gather evidence and communicate with affected women only gathered pace in December 2011 when the French government recommend 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.”
The MPs said government-ordered reviews of the issue, currently being carried out, must find out why action was not taken sooner “and whether sufficient effort was made to contact affected women”,