Stephanie Prior, Partner
Email Stephanie
In December 2011 an article was published in the National Post which revealed that the French Government proposes to pay for tens of thousands of French women to have breast implants removed if they are found to be responsible for causing cancer. The Government said that they would not pay for inserting new implants unless the patient can show that they had reconstructive surgery following a mastectomy.
This controversy hit the headlines at a time when breast implants are increasingly popular.
Apparently over 40,000 women in the UK have been warned that their brand of breast implants – poly implant prothese (or PIP, as the French silicone implants are referred to) were made using industrial mattress filling. In 2011, eight women with this type of implant developed cancer although the authorities have now dismissed a link. It would seem that the greatest fear is that these implants could be leaking. They have a higher rupture rate than normal implants which is usually 1% to 2%. However, the PIP implants rate is 5% according to the French authorities.
Cosmetic breast surgery is very popular. The first surgical procedure was carried out in 1962 in the UK and statistics show that approximately 10,000 women have breast implants in the UK each year.
The current PIP scare is not the first. In 1992, there was a silicone scare in the United States. The US Government temporarily removed silicone implants from the market in 1992 because they caused patient complications. Now silicone gel-filled implants are available again in the USA. The US Food and Drug Association (FDA) now approve silicone implants, and they are safe to use if a doctor feels that you are a good candidate for them. Although experts agree however, that Silicone implants are not right for all patients. Thereafter, many women in the UK simply opted for saline implants instead.
Trilucent Implants
Then in May 2000, apparently 5,000 women had received soya oil filled implants called Trilucent and these had to be removed due to concerns regarding toxicity. The Medical Devices Agency (MDA) was concerned about the long term safety data in relation to the Trilucent breast implants and the concern was in relation to the breakdown of the lipid filler. Accordingly, samples from the explants and the retained implants apparently contained millimolar amounts of at least one type of aldehyde; degradation product, which would react with protein and DNA. All women who had these implants were advised to have them removed.
This scare did not stop women wanting breast augmentation surgery and statistics show that between 2000 and 2007 the amount of women having implants went up by a massive 275%.
There are of course lots of potential risks and side effects associated with this surgery which can include post operative infection, chronic breast pain, breakage, necrosis of breast tissue, nipple numbness and leakage. Despite these risk factors breast augmentation surgery is accordingly one of the most popular surgical procedures carried out today.
PIP Implants
So, the controversial implants PIP have been linked by reports in France to the death of a woman from a rare form of cancer called anaplastic large cell lymphoma (ALCL). It has been estimated that 300,000 women around the World have PIP implants. In its day, the company was once the World’s third largest producer of silicone implants, producing 100,000 per year and exporting 80% of its output. However, PIP itself was shut down and its product was banned last year, after it became apparent that the company was using non authorised silicone gel that caused abnormally high rupture rates of these implants. More than 2,000 women have filed legal complaints against PIP.
In France, in the region of 523 women have had their implants removed and a further eight cases of cancer have been reported in patients with PIP implants. Currently, it has been announced that the Welsh NHS are to pay to replace privately fitted PIP implants. Women in Wales who have had PIP implants at private clinics can have them replaced for free on the NHS. To have the surgery, the women must prove that they have sought redress from their private care provider, and they must be resident and registered with a GP in Wales.
In December 2011, French authorities recommended that 30,000 women have faulty breast implants removed as a precaution.
Shockingly, Jean Claude Mas the PIP breast implant boss has been charged with causing bodily harm and has been placed under investigation on criminal charges. He is not being investigated on a more serious manslaughter charge over the 2010 cancer death of a French woman with PIP implants but he will face a separate fraud trial over the manufacture of the implants which is expected to begin in October 2012. Apparently Mr Mas had been using a home made silicone gel concoction to cut costs. This gel had not been approved for medical use and included a mixture of agricultural and industrial grade silicone. The French authorities banned the PIP products nearly two years ago and French women who have been campaigning against PIP since then have welcomed Mr Mas’ arrest and investigation.
So what can be done? I have received many enquiries from women who are concerned about their breast implants and I have recently met with two such women both who have received treatment at the same hospital under the same surgeon. Both are disappointed with the outcome of their surgery. Both are in constant pain and both women would like the implants removed as soon as possible. In fact one of these women feels that her implant is leaking and the other women definitely knows that her implant is actually folded in half and thus causing a tight band across her chest and this leads to constant pain. This is not what she agreed to. Unfortunately both of these women have been abandoned by their treating surgeon and the medical group who were initially happy to accept their money for payment of the surgery has been unwilling to provide them with any helpful advice. It would therefore seem that litigation is the only option.
Of course, if litigation is pursued the correct defendant will have to be identified and specific allegations of negligence will have to be included. Obviously each case will be different and some women will complain about the PIP implants and the fact that they should not have had these in the first place. Other women will be complaining because the breast augmentation surgery that has been carried out has not been carried out to the standard of which they required.
The UK Association of Aesthetic Plastic Surgery UKAAPS (http://ukaaps.org/) has created a register for women who have had breast augmentation surgery to log their implants and surgeon on to its sister site, The Breast Implant Association (http://www.breastimplantassociation.org/). This can easily help with early identification of any surgeon who has high complication rates and any implant with high problem rates so that the industry can be more proactive in resolving issues that arise. Further, Facebook support groups have also been set up to assist women to discuss the issues that have arisen from the PIP announcement.
PIP Implant Update
Claims may arise from this should those women affected by faulty poly implant prostheses (PIP) in the UK wish to take action to reclaim the costs of further corrective surgery. At the time of this article the position in the UK is that:
“In England, patients fitted with PIP implants by the NHS will have them replaced by the health service, while it will remove implants from private patients if their clinics refuse. The NHS in Wales said it would replace implants only when it was deemed medically necessary.
Women in Northern Ireland who received PIP implants for health reasons will have them replaced, but the NHS will only remove, not replace, those inserted for cosmetic reasons.
Scotland's Health Secretary Nicola Sturgeon said concerned women who had them fitted privately would be offered advice and the option of removal if necessary. There are no records of PIP implants being used by the NHS”.
Further, “Transform, which has just over 4,000 UK patients with the implants, had originally said patients would have to pay for removal. It now says those who have had the implants fitted since 2001 can have free removal - but will have to pay around £2,500 for replacements. Those who had replacements since 2006 may still be within their warranty period and would therefore get both removal and replacement for free”.
Also, “The Hospital Group also announced it would offer free removal for patients who had PIP implants fitted between 2001 and 2009 - but would charge between £1,500 and £3,500 for replacements”.
It all seems promising for those wanting redress. Although, it is likely to be very difficult for many women who will have to make a decision to have their implants removed and who will have to undergo a further surgical procedure to insert new safer implants, if that is at all possible.
Stephanie Prior is a Partner in Anthony Gold's Clinical Negligence department. For further information email Stephanie or call 020 7940 4000.
