Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 03 February 2012 | By Alexander Gaffney, RAC
A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP's breast implant products. The study, released 2 February 2012, calls for additional investigation, surveillance of the products and stress tests on the products.
The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) conducted the study, and noted that the inconsistent reliability of the data available to the investigators and the variability of product composition necessitate further study.
The report's authors note that some PIP implants have been manufactured using industrial-grade silicone instead of medical-grade silicone, which could dramatically affect the product's structural integrity and potentially lead to more severe adverse events if the implants ever rupture.
The investigators had two primary concerns regarding data integrity. In particular, the investigators were concerned that the total number of patients that have received the implants "is unknown due to patient tourism and poor record keeping by the manufacturers." Further, reporting of implant failure is optional, and data available to SCENIHR may not capture the full scope of adverse events.
The study found "no indication from the available data that the group of women who have had PIP silicone breast implants differ significantly from the group having implants from other manufacturers," but was unable to say if this finding was conclusive in light of their concerns.
The European Commission has already said that it will implement the report's call for additional investigation, surveillance of the PIP implant products and further stress testing on the implants.
Tags: Investigation, Report, Scandal, Breast Implant, Poly Implant Prothese, European Commission, PIP, France, French, Latest News, study
Regulatory Focus newsletters
All the biggest regulatory news and happenings.