The PIP breast implant scandal has been gathering pace since media reports on the subject released during the Christmas period underlined the potential seriousness of the situation for the estimated 300,000 women worldwide who have received these implants.
The anxiety of Irish women has been heightened due to a complete lack of relevant information being made available to them. In Britain there is an ongoing argument about what revision procedures will be allowable under the NHS and the boundaries have shifted over the past number of weeks in response to emerging medical data and pressure being applied by groups representing affected women.
Regrettably, as is so often the case here in Ireland, rather than adopt a proactive approach, the authorities would appear to be waiting to see what their British and European counterparts do first before announcing a plan of action for the women affected in this jurisdiction.
At this stage we have been contacted by a significant number of women who have had breast augmentation procedures performed at each of the clinics named in the Irish Medicines Board (IMB) statement of the 22nd December 2011, namely the Harley Medical Group, Shandon Street Private Hospital in Cork, and Clane Hospital Cosmetic Surgery Unit in Co. Kildare.
While we have also received many queries from women who suspect that they may have received PIP implants from other cosmetic surgery providers in Ireland, there is presently no firm evidence to show that any other clinics were using the defective devices. Our investigations for these individuals are ongoing, but based on what is known at present women who had procedures performed by other providers do not have anything to fear.
Based on the information imparted to us by the women calling us for advice, coupled with the statements being issued by providers, we have summarised below the situation being experienced by women in Ireland.
The Harley Medical Group’s latest statement (17 January 2012) shows that they are belatedly responding to the significant public and political pressure which has been applied and have agreed, in the UK at least, to remove and replace implants for free in individuals who have received them in the last 6 years for cases of confirmed rupture.
Individuals with older implants are offered free removal (up to 10 years) or replacement “at cost” (over 10 years). Again, this offer is confined to cases of confirmed rupture. We have yet to see if this policy is officially applicable to their Irish patients. However, based on discussions with some of the women who have contacted us, it would appear that those Irish women who have confirmed ruptures will receive an offer of free replacement.
The IMB has reported that the Harley Medical Group has finally sent out “direct specific patient contact letters” to women having received implants at their Irish clinic, after having previously made false claims to have done so in November 2010. The majority of women contacting our office report having received some form of communication from Harley Medical Group at this stage, by way of either e-mail or posted letter, but they have found these communications to be of little assistance or comfort.
In some cases we are hearing that the letter does not confirm categorically that the implants used were PIP but instead says that it is “likely” that they were. The letters go on to recommend seeking medical opinion on the matter, which is one of the few views expressed by the Harley Medical Group on this subject with which we are in agreement.
Again these letters do not address the issue of the significant financial burden faced by most of the women involved of having to organise private scans and other appropriate medical tests and procedures to determine if their breast implants have ruptured.
In the event that a woman who has had PIP implants used in her breast augmentation procedure learns that her breast implants are not ruptured, the clinics seem to think it reasonable that they should be content to carry on with the breast implants in place or to have them removed or replaced at their own cost.
At the time of writing Clane Hospital Cosmetic Surgery Unit has not made any public statements of which we are aware, aside from 3 sentences on their home page. The statement explains that Clane Cosmetic Surgery Clinic has been acquired by River Medical and that all of their former patients who received PIP breast implants have been notified and offered scans in 2010. This is followed by a link to a statement on the British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) website.
We have been contacted by several former Clane patients who have reported having only received communication from the Clane clinic in recent days. Other former Clane patients say they had received no communication from the clinic prior to them initiating contact themselves which, based on the website statement, would suggest that our clients have not received PIP breast implants. We will be gaining access to their detailed medical records on their behalves to confirm this.
The situation for former patients of the Shandon Street Private Hospital is more difficult again. A significant proportion of the women contacting us have had their surgeries performed at this facility. At present they face the added stress of not even having a number to call or an address to write to get confirmation regarding their status or quick access to their medical records.
We are currently attempting to determine the whereabouts of the records belonging to these women in order to establish what type of implants were used in each case.
We would offer the following advice to any woman who knows or suspects that she is affected by the PIP breast implant recall:
- Consult a doctor without delay if you are in any way concerned about the implants which you have received. This is the first thing you should do. Any legal issues which may arise in the event that you have received PIP breast implants should be put to one side until you are satisfied that you have received all appropriate medical attention Advice from a medical professional whom you can place trust in is essential. If you do not feel confident in the advice you receive from the clinic which performed your original procedure contact your own GP for guidance.
- Ensure that any communication you receive regarding your implants is personal to you and not a standard-form letter. Requesting your full medical records from the clinic is your right under data protection legislation and this will allow you to be sure that the information you are getting is actually applicable to you.
- Beware of signing any paperwork presented by the clinic which provided you with the breast implants. If you are being asked to enter into any written agreement before further action is taken on your behalf we would strongly recommend that you obtain independent legal advice before doing so.
- Keep a detailed written record of your experience. Make sure to include a full account of the manner in which you have been treated and keep a record of all travel expenses, loss of earnings and other outgoings which you have incurred. This information will be important in the event that legal action is ultimately found to be warranted.
- If revision surgery is to be performed, obtain written confirmation that the PIP breast implants that are to be removed in the procedure will be retained for you so that they may be examined later on should this prove necessary.
Finally this recently published joint surgical statement on clinical guidance for patients, GPs and surgeons (http://www.rcseng.ac.uk/publications/docs/pip-statement/) based in the UK may be of interest to women who have been affected.
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