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All women with defective breast implants entitled to surgical assessment and removal

Option should not depend on symptoms, says guidance for GPs and patients

Caroline White

Wednesday, 18 January 2012

All women with a PIP breast implant should be able to have an assessment by a surgeon, irrespective of whether they have symptoms, says new guidance aimed at GPs and patients. 

The guidance, drawn up by the professional bodies representing surgeons, goes beyond current government advice, in a bid to provide patients with practical help on their rights and expectations, and signpost GPs to the most appropriate routes of referral for patients with and without symptoms.

It recommends that all patients should be able to have an assessment by a surgeon, and should expect to have the implant removed, on request, regardless of whether they have symptoms.

And if a patient wants time to make up their minds this should be respected: surgery to remove implants must not be a time-limited “take it or leave it” offer, it says.

Scans should only be used as a tool to assist patients to make a decision and only after the patient has had a consultation with a surgeon. Scanning alone is not a reliable enough tool for detecting failure rates in breast implants, warns the guidance.

The guidance reaffirms the surgical association’s view that all clinics have an ethical and moral duty of care to offer these patients treatment without charge.

It has the backing of the Association of Breast Surgery, British Association of Plastic, Aesthetic and Reconstructive Surgeons, British Association of Aesthetic Plastic Surgeons (BAAPS), Federation of Surgical Speciality Associations and the Royal College of Surgeons.

BAAPS President Fazel Fatah said that the guidance would “remove any ambiguity about the right course of action, not just for women who have PIP breast implants, but to all those who become involved in their care and treatment—including GPs and surgeons."

Consultant plastic surgeon Tim Goodacre, Head of Professional Standards at the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) said: “It has been a distressing time for all the women caught up in the PIP breast implant issue. We hope that this comprehensive guidance, for both patients and healthcare professionals, will ensure we can conclude this effectively and with compassion.

We must now look at how cosmetic products and interventions are regulated in the UK more broadly so that we can avoid a repeat of this scenario. BAPRAS continues to be driven by patient safety and professional standards and we look forward to the next meeting of the Expert Group so we can discuss these points in more detail.”

His comments coincide with a swingeing critique published online in The Lancet today of the way in which medical devices are regulated in the UK.

The editor, Richard Horton, writes: “The operating principle at the [Medicines and Healthcare products Regulatory Agency] MHRA seems to be: do nothing until something goes wrong... Overall, the safety of medical devices is a low priority for the MHRA, with serious consequences for patient safety….

The MHRA’s mission is “to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe”. The MHRA is, by its own admission, unable to fulfil this mission.”

Poly Implant Prostheses (PIP) Breast Implants: Joint surgical statement on Clinical Guidance for Patients, GPs and Surgeons

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