Clinic failed to contact patients over breast implants
THE Irish Medicines Board (IMB) has accused a plastic surgery clinic of supplying it with "misinformation" about contacting women who received PIP breast implants.
The Poly Implant Prothese, produced by a French company that has since ceased trading, is said to contain an unapproved gel that becomes lumpy and granular, increasing the risk of tearing.
In a statement the IMB said that the Harley Medical Group supplied written confirmation twice in November 2010 that it had written to all of its Irish patients implanted with PIP breast implants.
"We have now been informed that this direct specific patient contact letter was never sent and communication to patients was via their website," the statement said.
It added: "The IMB is concerned that the Harley Medical Group did not follow the IMB recommendation and that the IMB was misinformed."
The board said it had received confirmation that a direct specific patient contact letter would now be sent by the clinic by Monday, January 9.
PIP breast implants were in use from 2001 to 2010 and some patients may have changed their name or address in that period.
The IMB has advised such patients to contact the clinic directly.
It has also contacted the UK's Medicines and Healthcare products Regulatory Agency notifying them of the situation in Ireland because Harley Medical has operations in the UK.
The advice of the IMB has remained unchanged which is that "there is no current evidence of particular health risks associated with PIP implants".
It has continued to advise women with these implants to seek clinical advice from their implanting surgeon if they have any concerns.
Yesterday, a British review of the risk from the implants found no link with cancer and no evidence to recommend their routine removal from 40,000 women in the UK.
However, British Health Secretary Andrew Lansley said any UK patient with PIP implants placed by the NHS could have them removed for free if doctors believed it necessary. Around 1,500 women have received the implants in Ireland.