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Implant scare response 'inadequate'

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an alert in March 2010 telling surgeons they should stop using PIP implants - the CE mark for PIP implants had been withdrawn following concerns raised in France.

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.

Health minister Paul Burstow said the report would be "useful" in strengthening the role of the regulator. "The duty of care which private clinics have is very clear. They need to remove these implants if necessary," he said. "We also need to make sure that the regulator has the teeth to do the job properly in future.

"Where it is clinically necessary the NHS will not only remove but will also replace implants which were originally done privately. For those who had cosmetic procedures, they will need to go back to the private provider who has a duty of care (for replacement implants)."

Speaking about the role of the regulator in the wake of the committee's finding that 20 months elapsed between a safety alert and "urgent action" being taken by the Government, he added: "This is one of the things which we are looking at in terms of the role of the regulator and levels of alert to go through."

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