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Letter to the Chief Medical Officer seeking further information about PIP Breast Implants’ regulatory status

The following is an open letter sent today to the Chief Medical Officer regarding the PIP breast implants issue, following up on our earlier letter of the 8th May, to which we have yet to receive a substantive response.

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Our Ref: EMcG Your Ref;   21st May 2012

 

Dr. Tony Holohan

Chief Medical Officer

Department of Health

Hawkins St.

Dublin 2

Fax: 6710148

 

Re: PIP Breast Implants


Dear Dr. Holohan,

We write this as an open letter to you and will put it on our website.

We refer to our previous letter of 8th May 2012.

As you know we are instructed by a number of women that have been fitted with defective breast implants manufactured by Poly Implant Prothèses (PIP) and in connection with their claims for personal injuries arising therefrom.

In that capacity and because you are leading the state’s response to the predicament of our clients and we perceive you as being of goodwill to our clients we would be obliged if you would supply us with the following information:

  1. Are you satisfied that the PIP breast implants did not conform with the prohibitions on putting them into service in the state or selling them, contained in the European Communities (Medical Devices) Regulations, 1994 as amended by the European Communities (Medical Devices) (Amendment) Regulations, 2001?
  2. If so, what steps, if any, does the state intend to take arising from that view?
  3. Did the Irish Medicines board issue a licence under Regulation 3 of the Medicinal Products (Licensing and Sale) Regulations, 1998 for the placing on the market and sale of PIP breast implants?
  4. If so, to whom was the licence(s) issued?
  5. Were the PIP breast implants subject to the terms of Regulation 5 (1) (c) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 as amended by the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008, and required a prescription?
  6. Do you know if there were generally such prescriptions associated with the fitting of the breast implants?
  7. Are you satisfied that any advertising for the sale of defective PIP breast implants was in breach of Regulations 6 (1), 7, 9, 11 (1) (b) and 12 (1) (b) of the Medicinal Products (Control of Advertising) Regulations 2007?
  8. If so, what steps, if any, does the state intend to take arising from that view?

We await hearing from you in due course.

 

Yours faithfully,

 

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McGarr Solicitors

PIP Implants