PIP breast implants 의 안전성 경고

Safety alert

2012-01-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20120110.html

Dh maintains vigilance over safety of pip breast implants a spokesman for the department of health (dh) reiterates today (january 9) that the department is continuing its monitoring on a medical device safety incident related to breast implants of substandard quality manufactured by a french company, poly implant prothese (pip). "to recapitulate, the french medical device regulatory authority ordered in 2010 the recall of pip implants in france after it found out that pip had used non-approved silicone in the implants' gel. the threat was an increase in the rupture incidence," the spokesman recalls. no sooner, a number of other countries and places, including hong kong, followed suit to recall the pip implants. "then, on december 23, 2011, the french ministry for labour, employment and health moves one step further to recommend prophylactic removal of inserted implants because of higher rate of rupture identified in france," the spokesman reveals. however, the spokesman elaborates that france's information is neither easily accessible for further risk assessment nor is the observation universally shared by other competent authorities. the former can be due to france's criminal investigation into the matter which may make the publication of critical scientific data scarce, if at all available. "nonetheless, as dh always has the safety of and compassion for local clients who have had the implants, we have been trying hard to follow up on the event's development, including liaising with our mainland as well as overseas counterparts, and continuously refining our risk assessment as new data comes in," the spokesman remarks. based on information gathered thus far, dh understands that to date, whether locally or abroad, there is no clear evidence of higher than expected rupture rate anywhere else outside france. in addition, australian and british authorities report that their laboratory analyses on the non-approved gel find no cancer causing chemical nor dangerous toxin. "however, as neither organisation is confident that the manufacturer did not change the silicone in the implants, understandably neither would rule out the possibility that some of the implants' gel can be cancerous and/or toxic," the spokesman supplements. "in hong kong, based on information captured by our medical device administrative control system and coupled with communications with stakeholders, including service providers in the academic, private and public sectors, and users, dh reckons that there is no official record of sale of pip implants or its rebrands here. indeed, pip does not appear to be a popular manufacturer in the local market," the spokesman says. "moreover, it is reassuring that despite the fact that we have issued public and professional statements about pip implants over the past two years, dh has not received any related adverse incident report," the spokesman comments. "taken all information in hand together, dh is of the view that at this stage, notwithstanding that there is no official documentation of hong kong has clients with pip implants or it rebrands inserted, there is insufficient evidence of a problem with pip implants supplied outside france to warrant their routine removal here," the spokesman states. "in fact, should there be clients who have had pip implants inserted anywhere outside france, like all others who have silicone gel breast implants, they are strongly advised to go for routine follow-up and should consult their healthcare professionals if they have any concern," the spokesman stresses. the spokesman adds that, "as breast reconstruction is a surgical procedure which requires a patient’s informed choice, potential users are advised to discuss with their healthcare workers before making a decision. opportunity is also taken to remind the latter that they should report adverse events related to pip implants to the medical device control office of dh.” meanwhile, dh's monitoring on the pip implants situation goes on and updated advice will be issued as investigation and analysis of data continues. end.