PIP Breast Implants - UK Dept Of Health Response To Expert Report

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Main Category: Cosmetic Medicine / Plastic Surgery
Article Date: 13 Jan 2012 - 9:00 PST

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According to the Department of Health, their main concern is the wellbeing of women who have had PiP breast implants. For this reason, an expert group led by Professor Sir Bruce Keogh, NHS Medical Director, has been asked to examine all available data and evidence on PiP breast implants.

The experts concluded that:

• There is no association with PiP breast implants and cancer
• Advice given by the MHRA still stands
• That there is insufficient evidence to recommend routine extraction of PiP breast implants.

However, the group explains that these implants should have never been implanted in women in the first place, as they are made up of non-medical grade silicone. The Department of Health knows that this data will be a worrying for women who have PiP implants. Those who performed the implantations should properly support these women.

Patients with concerns regarding this issue should talk to their GP (general practitioner, primary care physician), or surgeon.

If the woman still has concerns after consulting with her doctor and decides to remove the implants, the NHS will support the removal and replace the implants if the original breast implants was done by the NHS.

The Department of Health expects that those in the private sector do the same for their patients, as private providers have a responsibility to provide appropriate after-care to individuals they have treated as they have legal obligations to their patients.

The NHS will offer a package of care for its patients, and The Department of Health expects the private sector to do the same.

The NHS offer is:

• The NHS will contact all individuals who have received breast implants from the NHS in order to inform them that they have a PIP implant and provide relevant information and advice. The NHS will provide information free of charge should patients seek information about the make of their implant.
• Consultations with their GP, or with the surgical team who conducted the original implant, should the women seek clinical advice on the best way forward.
• Consultations may include imaging scans to determine whether there is any evidence the implant has ruptured.
• The NHS will remove PIP implants if a woman (with her doctor) decides that it is the right thing to do, and and there is an assessed clinical need. If the original procedure was conducted by the NHS, the NHS will replace the implants.

The Department of Health is collaborating with the private sector to make sure an equivalent model of care is provided, as it's unfair for the taxpayer for the NHS to pay the bill.

The NHS will support removal of PiP implants, in line with the guidance above, should the clinic that carried out the operation refuses to care for their patient - where the patient is entitled to NHS services, or no longer exists. The replacement of private cosmetic implants would not be included by any NHS service in that respect. In order to avoid the taxpayer footing the bill, the Government will pursue private clinics with all means at its disposal.

However, the experts are unsure whether the rapture rate is higher for PiP implants than other breast implants.

Studies reveal that if a PiP implant did rupture, there is no risk of dangerous toxins leaking into the body, although the experts are not confident that the manufacturer did not alter the silicone in the implants and therefore cannot rule out that some implants may be toxic.

According to the Department of Health:

"We need to do everything we can to ensure the safety of people having cosmetic surgery.

It's clear from the information we have received from the industry that the safety information it has provided to the regulator is patchy. Without good data, we have no way of knowing when problems arise."

The expert group will analyze the broader issues surrounding the quality of surveillance, data, and enforcement of the sector and sector regulation more generally.

Evidence of providers' compliance with registration requirements are being reviewed by The Care Quality Commission as well as considering a fuller program of inspections.

In addition, the UK and France will continue to collaborate in sharing data and information. Both nations are determined to prevent this situation from happening again. The UK would like to collaborate with countries across the EU in order to fully understand where the failures of this incident fall.

Health Secretary Andrew Lansley explained:

"Throughout the past few weeks, my main concern has been for the safety of and compassion for women who have PIP implants. It has been a worrying time for these women. We have at every stage sought to offer them as much advice and evidence as is available to us.

Our advice remains the same that there is not sufficient evidence to recommend routine removal. We have always recommended that women who are concerned should speak to their surgeon or GP. The NHS will support removal of PIP implants if, after this consultation, the patient still has concerns and with her doctor she decides that it is right to do so.

We believe that private healthcare providers have a moral duty to offer the same service to their patients that we will offer to NHS patients - free information, consultations, scans, and removal if necessary.

Throughout this process we have followed expert advice. The data available to the experts has not been good enough to enable them to give a clear recommendation of the risk posed by PIP implants. We will therefore support women, including removal of the implant, if needed."

Professor Sir Bruce Keogh said:

"The overriding consideration of the group is the safety and compassionate treatment of women with PiP implants.

On the basis of the information we have, we do not think it is necessary to recommend the routine removal of these implants. But we understand that some women will be very concerned so we support the Government's position that the NHS will support removal of PIP implants if the patient has concerns and with her doctor she decides that it is right to do so."

Written by Grace Rattue
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Not to be reproduced without permission of Medical News Today

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