PIP Breast Implants Advice

Previous Patients of Mr Murphy:

Patients with breast implants have been advised to contact their surgeons to identify the type of implants that were used in their surgery. I would like to reassure all my patients that I have never used PIP breast implants.

I have always been concerned to ensure that all products I use are of the highest quality and had previously assessed and rejected PIP implants as poorly manufactured products, with the potential for high rupture rate.

If you are concerned that you have, or may have, PIP implants from another surgeon or clinic, please see the advice below

Patients with PIP implants:

Should you have any friends who have undergone breast implant surgery elsewhere, and are concerned about the safety issues the advice is simple :

•     Contact your surgeon or surgical provider to identify your implant manufacturer
•     Any patient who has had a PIP implant used since 2005 should see a surgeon and have an ultrasound examination performed
•     If the ultrasound shows signs of rupture, or if there is any evidence of silicone within the tissues then the implants should be replaced
•     If there is no sign of rupture then the patients should be reviewed on an annual basis

I am happy to see any concerned patients and provide advice. I have set up a number of clinics where I will see and assess patients free of charge.

Should anyone wish to find out more about these clinics, they can call my Practice Manager, Sue Hinchcliffe, on 0161-232-2670.

Rates:

I have been able to negotiate reduced rates from my hospital and implant providers so that I can offer exchange of PIP implants for either Allergan, Nagor or Silimed, life-time guaranteed implants from £3200. I would be happy to discuss the appropriate choice of implant with you at your consultation.

The Problem with PIP implants:

The latest information from French Society of Plastic Surgery (SOFCPRE) warns of two concerns with the PIP breast implants. The first problem is that the manufacturing company seem to have dispensed with part of the protective barrier around the gel, leading to a weaker implant that is more liable to rupture. The second concern is that the gel inside the implant is not the gel that the company was issued a license to use. The French regulatory authority who issued the license to the company are still undertaking tests on the gel in an attempt to determine whether the gel presents a health risk – we will keep you updated. At this stage we suggest following the guidance given by BAAPS (The British Association of Aesthetic and Plastic Surgeons).

BAAPS  released an interim statement to provide advice for patients with PIP breast implants:

NEW UK GUIDANCE ON CONTROVERSIAL FRENCH IMPLANTS

Protective Barrier Had Been Dispensed With – Women Urged to Have an Ultrasound

London – 18 June, 2010 – The British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk), welcomes today the clarification provided by a detailed study into France’s controversial PIP implants by the French Society of Plastic, Reconstructive and Aesthetic Surgery (SOFCPRE). The BAAPS, the not-for-profit organisation established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit, today issues new safety recommendations to the UK public such as a call for all women who have PIP implants to undergo an ultrasound scan in the next six months, to determine whether there is any rupture or weakening.

Despite proving unpopular with the majority of BAAPS members, it has been estimated that roughly 50,000 women in the UK could have these breast implants, as they were the product of choice for some clinics.

According to consultant plastic surgeon and BAAPS President Nigel Mercer:

“This comprehensive study concludes this situation is clearly not the fault of the surgeon, who acted in good faith – it would be similar to blaming a dealership for a faulty car. There was no way of knowing the gel was untested or that the protective envelope, which adds strength and restricts the gel from traveling into the body, had been dispensed with.”

The study by SOFCPRE found that the company making PIP implants, which has now gone into administration, not only dispensed with the protective barrier since 2005 but was also using a gel (within the implant) which had not been the one tested originally for its CE mark, ie, to make its use legal. To determine how the altered version might react with the human body, SOFCPRE contacted the gel manufacturers for any studies – however, these were unavailable, as they had understood the substance to be intended for use in mattresses.

Nigel Mercer adds:

“This is certainly an unusual situation but so far there is no serious cause for alarm – whilst further tests are conducted into the substance, we recommend that women who’ve undergone breast augmentation contact their surgeons to find out what type of implant was used. If it’s PIP they should have an ultrasound in the next six months to establish whether there is any weakening or rupture. At present removal is recommended in these cases, but if there is one ruptured implant, the contralateral one should be taken out as well, as a preventative measure.”

What if they are not ruptured?

This is a more difficult group for me to advise. At the moment, the government is advising that there is no medical reason to remove these devices, but the whole scandal has understandably shaken the industry’s confidence in the implants. I think it is unlikely that the government will support the exchange, or even removal, of apparently intact implants and these women are likely to be expected to pay for the peace of mind of having their implants exchanged for a more reputable brand.

Fazel Fatah, President of BAAPS and one of the members of the government-commissioned panel investigating the scandal, said private clinics have an “ethical and moral obligation” to patients after fitting them with cheap implants.

“My personal view is the clinics which originally profited from these implants have an ethical and moral obligation to these patients,” he told The Daily Telegraph.

Unfortunately, I think that many of these commercially ruthless clinics are unlikely to agree to free exchange without a legal fight. They will argue that they supplied the implants in good faith and had no reason to suspect that the quality of the implants was sub-standard. If this is the case, it will undoubtedly take several years to resolve this issue, which leaves many of these understandably worried women in a difficult position.

I am inclined to agree with Tim Goodacre, a previous  colleague of mine and current President of BAPRAS, who said that if the government panel confirmed the initial findings – in which almost one in 14 implants had leaked – then they should all be taken out in every case.

“With this sort of level of implant failure, particularly with this sort of material that isn’t medical grade, it’s sensible that they be removed,” he told The Daily Telegraph. “I think that would be a reasonable way forward.”

We both think it unlikely that the Department of Health would make a decision on whether or not to recommend blanket removal until it had scrutinised data from across the industry in more detail.

Due to the way information on breast implants is held – individually by clinics but not centrally – he warned that could take “weeks”.

Future developments:

4^th January 2012: The government is meeting today with leaders of BAAPS and BAPRAS to discuss the management of the PIP problem. An announcement can be expected at some stage after this meeting, though no timescale has been given. Watch this space for further developments.