The IMB maintains its official line that only patients of the Harley Medical Group, Clane Hospital and Shandon Street Hospital received PIP implants despite the obvious misunderstandings that arise because many patients contracted with a particular provider, e.g. Advanced Cosmetic Surgery or The Hospital Group, but were sent to Shandon Street Hospital for the surgical stage of the augmentation procedure.

Our request for a complete list of any cosmetic surgery providers whose patients may have received PIP implants appear to have fallen on deaf ears. The IMB have failed to address the request in our e-mails.

Meanwhile the IMB website has published its first news update on the situation in just under a month. The five-line update links to a report by the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and concludes that results are uncertain. The recommendation by the IMB continues to be that patients should consult with their implanting surgeons on what action they should take.

This advice is of little comfort to women who have done just that, given the responses many have received. Clients have reported to us again and again statements by the surgeons involved that if they were to remove all the problem implants they would go bankrupt. The clear conflict of interest in such an arrangement makes the IMB recommendation seem slightly ridiculous.

To add to this there is the concern that clinics are cynically exploiting the duress many women find themselves under, financially and mentally, to insist that they sign comprehensive waivers and indemnities absolving the clinic for any injury or loss that may have resulted, or may result in the future from the faulty implants as is the case with The Hospital Group. If the implants are so benign why are they insisting that such weighty legal documents be signed prior to removal?

This behaviour would be objectionable enough if it was in return for a worry-free removal or replacement, but each of the women who report having had such an offer from the Hospital Group explain that they are required to travel to England for the surgery at their own expense. All of this after they are first required to establish that their implants are in fact ruptured, which again they must do without any assistance from the clinics, usually at a cost of between €200-€600.

The SCENIHR report referred to above is a 74-page document which requires a level of expertise to fully comprehend. It is written from a sceptical point of view which does not draw conclusions in the absence of proof as any scientific paper should be. However it is important to note that the report states that it is based on limited data because there is no representative PIP implant, the quality and ingredients of the implants varied over the 9-year period in which they were manufactured.

A different, more human, approach is necessary for the approximately 1,500 Irish women and reported 300,000 women worldwide who are aware that they have objects in their bodies that should not have been approved approved for such use. The position that there is no need to remedy their situation until it can be proven that they are at risk seems short sighted and does not take into consideration the stress and worry these women are suffering everyday as they try to figure out how and where they will have the implants removed.

We will be posting exclusive information on this unfolding situation as we become aware of it.  If you found this post useful or interesting, you might like to subscribe to our mailing list below to ensure that you don’t miss any important updates.

We will be posting exclusive information on this unfolding situation as we become aware of it.  If you found this post useful or interesting, you might like to subscribe to our mailing list below to ensure that you don’t miss any important updates.

We will be posting exclusive information on this unfolding situation as we become aware of it.  If you found this post useful or interesting, you might like to subscribe to our mailing list below to ensure that you don’t miss any important updates.

I reported in our blog post of 20 January that we have been receiving calls from women who have been contacted by cosmetic surgery providers not named in the Irish Medicines Board (IMB) statement informing them that they did in fact receive PIP breast implants.

The IMB, after 5 days, has responded to my query on the matter confirming what had been reported by several women who have contacted us, namely that women who organised their breast augmentation surgery through The Hospital Group did indeed receive PIP breast implants in many cases.

Why was The Hospital Group not mentioned in the IMB statement of 22 December or subsequent statements up to and including the latest dated 6 January? The following extract from their e-mail reply to our enquiry explains:

“In relation to your query regarding PIP implants and The Hospital Group.

The IMB has been in communication with The Hospital Group in relation to this matter. From the information provided to the IMB, all patients of The Hospital Group which received PIP implants did so in the Shandon Clinic in Cork or in the UK.

We believe that this is reflected in the information currently on the IMB website. The IMB’s position as outlined on our website is unchanged since the 6th January.

The website will be updated as required.”

Our clients who arranged their surgery through The Hospital Group do indeed report having been sent to Cork or the UK for the surgery but, understandably, only a minority of them could recall the address of the clinic in which they were operated on asin most cases several years have passed since the procedure.

The reluctance of the IMB to specifically name The Hospital Group in their statement is difficult to understand when they have confirmed that Hospital Group patients received PIP breast implants.

The Hospital Group, to their credit, have been contacting their former patients and informing them that PIP breast implants were used in their augmentation procedures. This is how each of our clients learned that they received PIP breast implants. However, patients whose contact details have changed in the period following their operations will not have received these communications and upon reading the IMB statements might well be lulled into thinking that they have nothing to worry about.

We have also received a small number of enquiries from women who had breast augmentation procedures organised through Advanced Cosmetic Surgery Limited, a company which has been in liquidation since 2008. Again these women do not recall the address at which their surgery was performed, merely the company they organised it through.

Advanced Cosmetic Surgery Limited is not named in the IMB statement either and we will again have to seek clarification from the IMB to establish if these women may have received PIP breast implants from another company that remains unnamed in their statements to date. We have also sought the medical records of the individuals concerned from the liquidators but this is likely to take some time.

Surely a clear statement from the IMB clarifying precisely which providers of breast augmentation surgery may have used PIP breast implants is necessary, whether direct providers or companies who subcontracted out the surgical aspects of the process, so that any woman potentially affected can take appropriate steps to ensure their health is not adversely affected.

This is particularly true when the Shandon Street Hospital, the clinic at the centre of this particular misunderstanding, is:

(a) gone into liquidation and not contacting any former patients, and

(b) also a former provider of implant surgery trading under its own business name, which is the main reason for the confusion.

The IMB’s minimalist approach in identifying the cosmetic surgery providers implicated in this scandal is indeed regrettable. One would have hoped that a tougher line would be taken with these companies, particularly bearing in mind the manner in which the Harley Medical Group played ducks and drakes with the IMB on the issue of notifying women affected by the recall.

We will be posting exclusive information on this unfolding situation as we become aware of it.  If you found this post useful or interesting, you might like to subscribe to our mailing list below to ensure that you don’t miss any important updates.

We will be posting exclusive information on this unfolding situation as we become aware of it. If you found this post useful or interesting, you might like to subscribe to our mailing list below to ensure that you don’t miss any important updates.

Having witnessed the anguish and worry that the Irish women who are affected by the PIP breast implant scandal have been forced to undergo, it’s hard to see any positive aspect to this whole sorry saga.

But in a strange way there may be one positive thing to emerge from the calamity.  There have been several occasions over the years when the dodgy side of the cosmetic surgery industry has become the subject of media scrutiny.  However, the attention has usually been confined to commentators with a specific interest in the field and has been short-lived.

As a result, the several controversies that have arisen over the years have not had any significant consequences in the longer term, with unscrupulous practitioners being free to get back to business as usual after the furore eventually died down.

The sheer scale and extent of the PIP breast implant scandal means that, this time, things might be different.  There is hope that the sense of outrage that prevails may be harnessed to drive meaningful reform of the sector.

In this regard the statement made yesterday by the British Association of Aesthetic Plastic Surgeons (BAAPS) is to be welcomed.  The BAAPS has set out a six-point plan which it claims will lead to a safer and more consumer-friendly cosmetic surgery market if followed.

The six points are as follows:

• Ban all advertising of cosmetic surgery.
• Establish an implant register.
• Classify dermal fillers as medicines and control them accordingly.
• Impose compulsory registration of practitioners in aesthetic medicine and lasers.
• Conduct mandatory safety audits.
• Revalidate CE marking of medical devices.

This contribution by the BAAPS is to be welcomed and is as important in this country as it is in Britain.  As with so many other situations in the past, it is probable that this country will follow the lead which is shown to it by the UK when it comes to adopting the appropriate response to the PIP breast implant debacle.

What we need now is a meaningful and informed debate which will eventually lead to the effective regulation of the cosmetic surgery sector.

Some may have legitimate concerns with one or more of the proposals put forward by the BAAPS.  For example, it might be argued that an outright ban on advertising cosmetic surgery services would amount to an extreme form of nanny-statism.

But as long as the effect of BAAPS’s proposals is to engender a dialogue which ultimately delivers meaningful reform of the industry so that rogue practitioners are prevented from inflicting any more harm, it can only be seen as a good thing.

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Remember the hundreds of angry placard-wielding protestors outside Leinster House howling for legal reform?  Surely you’ll recall Joe Duffy’s facilitation of endless hours of bilious remonstration on the subject?  No?  Me neither.

Indeed it’s fair to say that this was an area of the law to which absolutely no legitimate controversy or uncertainty whatsoever attached prior to the passing of the legislation.  In fact, no matter how diligently you trawl through the law books, it is nigh on impossible to find a precedent where a good Samaritan was successfully sued for the consequences of their selfless actions.

As Professor William Binchy has observed with characteristic insightfulness, the legislation appears to have been passed “to accommodate panic and irrational assessment of risk of litigation by changing the law in accordance with that irrationality rather than seeking to educate those with such irrational beliefs.”

And for those of you who think that, while the busybodied and otiose codification of an area of the law is not to be encouraged, at the end of the day it’s something of a victimless crime, think on:  the Act provides that a good Samaritan shall not be personally liable in negligence for any act done in an emergency when providing assistance, advice or care to a person who is in serious and imminent danger unless the act is done in bad faith or with gross negligence.

It is not difficult to conceive of scenarios where this provision could have unintended and perverse consequences.  Binchy provides a compelling example:  consider a situation where a drunken driver mows down a child pedestrian with his car and then gets out of the vehicle and attempts to provide the injured child with assistance, thereby worsening the child’s condition.

As long as the intoxicated driver can show that he was acting in good faith, and that his actions were not done with reckless disregard for their consequences, his legal exposure to the child will be confined to the injuries caused by the actual collision itself and he will escape liability for having subsequently exacerbated the injuries.

One would be forgiven for suspecting cynical motives for the passing of needless laws such as this.  But a more benign inference allows for the object of the legislators’ exercise to be identified as an effort to redress a perceived unwillingness on the part of citizens to become meaningfully involved in their communities, as the Act goes on to introduce similar provisions to insulate people engaging in voluntary work from civil liability for any damage caused by their volunteerism.

While, admittedly, many commentators have lamented the demise of people’s sense of civic duty which has seen an increasing reluctance to become involved in voluntary work, it’s a bit of a stretch to suggest that the reason that citizens aren’t getting out there and doing their bit for society is because they’re scared witless that they’ll get taken to the cleaners if they do.

Another potential danger arising from the passing of this legislation is that it may cause self-appointed defenders of the public good incorrectly to deduce that as long as they’re satisfied that they’ve got right on their side (as, of course, such individuals invariably are), the law will protect them from being pursued for any damage caused by their do-gooding negligence.

I was reminded of the dangers of such vigilantism when I recently watched the You-Tube clip below which has become a viral sensation.  The video, which has by now been seen by over two million viewers, shows a gentleman who has affectionately been dubbed the “Big Man” by his supporters (of whom he has many, judging from the Facebook tribute page which has been set up in his honour), taking it upon himself to eject one of his co-passengers from a train carriage for allegedly having failed to pay his fare.

The man who was thrown off the train is, somewhat understandably, none too pleased at having been turned into a hate figure on the Internet and claims that he suffered personal injuries in the scuffle that ensued when he tried to resist being hurled from the carriage.

How the controversy now unfolds will be interesting indeed, with Scotland’s Crown Office finding itself faced with a real poser.  If it doesn’t bring charges against the “Big Man” for having injured another passenger it could be seen to be encouraging others to assume the role of the vigilante in similar circumstances.  If, on the other hand, a prosecution ensues, the authorities could be seen as persecuting what some tabloid commentators have described as a “modern hero” and sending out a message that it’s best not to react when faced with antisocial behaviour and just to keep your head down.

No matter how this particular cause célèbre plays out, one thing is for sure: tinkering with an area of the law that doesn’t require fixing is certainly not going to help society to address the big issues that we now face concerning our increasing collective hesitancy about active participation in our communities.

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On the 31st March 2010 the Irish Medicines Board (IMB) announced an official recall of all silicone implants manufactured by a French company named Poly Implant Prothese (PIP).

The recall was originally ordered after the French medical device regulatory authority discovered that the implants have a significantly higher than average rate of rupture due to the defective nature of their outer shell.

Investigations which have been conducted since the recall was announced have shown that, rather than using medical-grade materials, PIP had been filling its implants with industrial-grade silicone containing fuel additives called Baysilone, Silopren and Rhodosil which are industrial materials not approved for clinical use and which can have potentially harmful effects on human health.

Symptoms after a rupture include swelling, pain, burning, rippling, lumps and hardness. If the silicone migrates to the lymph nodes lumps may be observed under the armpit. In some cases where a rupture has not occurred the implants would also appear to allow a ‘silicone bleed’ into the system without women experiencing noticeable symptoms. While there has been some concern expressed that the silicone used in PIP implants could cause cancer, there is presently no scientific evidence to prove this link.

These implants have been on the market since 2001 and, according to the IMB’s statement they were used by three private clinics in this country, namely Harley Medical Group in Dublin, Clane Hospital in Co. Kildare, and the Shandon Street Hospital in Cork. The IMB has further stated that approximately 1,500 Irish women are affected by the recall.

While we are representing women throughout the country from each of the three clinics mentioned above, we are also acting for women who have received confirmation from other clinics not referred to in the IMB’s statement that PIP implants were used in their breast augmentation procedures. The figure of 1,500 must therefore be regarded with some scepticism and we would advise all women who have undergone breast augmentation procedures in Ireland in the last ten years to make contact with the clinic where the surgery was performed to identify the manufacturer of the implants used in their procedures.

If these investigations confirm that PIP implants were in fact used, we recommend that immediate medical attention should be sought to determine whether the implants have ruptured and to ascertain whether urgent clinical intervention is required.

Once these initial medical issues have been addressed we are advising women to seek legal advice without delay to establish what their rights are regarding any costs and expenses which they incur as a result of the recall and whether they are entitled to compensation for any pain, suffering and inconvenience which they have been subjected to.

McCarthy & Co. have extensive experience in representing clients nationwide in relation to product liability and medical negligence claims. We have established a dedicated team which is committed to providing expert advice and assistance to women affected by the PIP breast implant scandal.

Our specialist team is headed up by John McCarthy who is a partner with the firm. John is collaborating with Joseph McCarthy who is an associate solicitor focusing on cases of this nature.

If you have been affected by the PIP breast implant recall and would like to discuss your case in complete confidence and without commitment, feel free to contact either John or Joseph on 023 883 3348. Alternatively, you can make contact with John by email at john@mccarthy.ie.

A small number of women have been successfully able to verify that the implants they received from the Harley Medical Group are not PIP brand and, thankfully, will not need our services.

Others are reporting that they have had it confirmed that they did in fact receive PIP breast implants. They are then faced with a difficult choice if those implants are not ruptured as they are expected to pay for any steps they wish to have taken, whether that be removal or replacement.

We have also received calls from several women who tell us they have had breast augmentation surgery at a chain of clinics that was not mentioned in the IMB statements to date. The surgeon they met with told them they did in fact receive PIP breast implants. We have contacted the IMB for their comment on this and await their response. The name of this fourth clinic cannot be revealed until we have some written confirmation but we have no reason to doubt the information being provided to us by our clients.

We are now getting more information from patients detailing how they are being treated in consultations with surgeons in two of the clinics and can report that Harley Medical Group appear to be following the line they officially took in their 17th January press release as described in our blog post of yesterday. This is hardly a generous offer but they have at least clarified their position which takes away some of the uncertainty.

In other clinics women are reporting that they are being offered free removal in any case and free replacements for ruptured implants. Those patients wanting to have un-ruptured implants replaced are being charged a rate which is about 60% of what they paid to have the defective implants inserted on day one.

In all cases the burden has been left firmly on patients who have received implants to arrange and pay for their own scans. Some women have received offers to pay for scans retrospectively if the implants turn out to be ruptured.

The exception is still the Shandon Street Hospital. Patients of this now closed hospital still await any news on their implants. While the IMB statement makes it clear that PIP breast implants were used by this clinic, we have yet to hear from clients who have been able to confirm that their implants were in fact manufactured by PIP. We are actively seeking their medical records but it seems likely that they will be the group who remain in the dark for longest.

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