The content of this website is intended for healthcare professionals only

“Inadequate” response to PIP implants scare say MPs

All providers should replace faulty PIP implants, claims report

Adrian O'Dowd

Wednesday, 28 March 2012

The government and the UK medicines watchdog regulator’s response to the PIP breast implants scandal was “inadequate”, according to MPs.

The health select committee has today published a report of its inquiry into the PIP implants scandal, which came to light last year.

Around 47,000 women in the UK are thought to have received the former French manufacturer PIP’s breast implants, which were found to contain non-medical grade silicon, prompting concerns about their safety.

The select committee has criticised the response in England to the issue, which first emerged as a possible problem in March 2010, but which did not gain significant focus or publicity until December 2011.

The report says: “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 Medicines and Healthcare products Regulatory Authority (MHRA) and the Department of Health also had a duty to raise public awareness. A more creative approach should have been used.”

MPs were concerned about the quality of information available about devices that were implanted into patients, saying it was essential for good medical practice for the maintenance of a full audit trail of devices implanted into patients.

They were also concerned by evidence that MHRA notices withdrawing CE registration from individual products did not require any positive response from non-NHS users of those products.

In their report, MPs welcomed the government's promise that the NHS would remove and replace any NHS implant that had failed, and agreed with the government that all other care providers should make the same offer.

For women who had implants done privately, as the vast majority of the 47,000 women did, the committee agreed with the government pledge that the NHS would remove non-NHS implants in cases where the woman was unable to obtain treatment from her original provider.

However, the committee urges the government to agree a protocol under which a replacement implant could be inserted in the same operation if that was the wish of the woman, with the support of her clinicians.

The cost of all care linked to non-NHS implants should be recovered, where possible, from the original care provider, or their insurers.

The fact that the government has commissioned two reviews – one by Sir Bruce Keogh to assess the regulation of cosmetic interventions in general and another led by Earl Howe to analyse the policy reaction, in particular by the MHRA and the Department of Health to the announcement by the French authorities in March 2010 that PIP products did not comply with the requirements of their CE registration – was welcomed in the report.

Committee chair Stephen Dorrell said: “We are broadly supportive of the immediate actions taken by the government in response to the events of December 2011, but we believe the wider facts surrounding the use of PIP breast implants raise some important concerns.

“The information available is acknowledged to be insufficient either to allow the regulator to make evidence-based judgements about the safety or otherwise of implants that were in widespread use, or to allow patients' clinicians to know whether their individual patient is affected. This is clearly unsatisfactory.”

Registered in England and Wales. Reg No. 2530185. c/o Wilmington plc, 5th Floor, 10 Whitechapel High Street, London E1 8QS. Reg No. 30158470