Former Head of Manufacturing Knew French Implants Were Potentially Defective

Princess 19 on 30 Dec 2011 at 9:00am

The former head of the now shuttered manufacturer PIP has admitted to knowing that the gel used in the implants was inferior.

Jean-Claude Mas confessed through his lawyer today that Poly Implant Prosthesis (PIP) knowingly used inferior gel in their breast implants.  According to Mas, there were apparently two types of gels utilized to make their implants, a high-grade gel intended for wealthier patients that paid for higher quality and a low grade, non-tested version used to meet "economic objectives" and sell more implants.

There was no intent to have the subpar gel approved by the AFSSAPS, France's health regulator, which tests drugs and medical equipment for safety.

Ruptured PIP Implant via Daily Mail

PIP "did not formally receive approval [for the lower grade gel], and in this regard there was a violation of regulations," as told to UK publication, The Times.  

However, the 72-year-old Mas still stands by the quality of the untested version.

"PIP knew it wasn't in compliance, but it wasn't a toxic product," he added.  "The fact that it's an irritant (when ruptured) is the same for all silicone gels."

The company's ignorance to safety concerns "to get the best cost" is both controversial and appalling.

The admission - as well as shocking support - is no reassurance for those patients that received the defective equipment or the families that have suffered through the loss of loved ones.  

Since the recent announcement that the French government will pay for all French victims' defective implant removal, other countries have been prompted to help potential victims and take action.

Israel is taking precautions regarding the PIP implant scandal and setting up a hotline for potential victims.

Almost 900 Israeli women have received the defective breast implants from PIP, according to the Daily Mail.  The cheaper implants account for 5% of the country's total implant surgeries.

Other noteworthy updates regarding this incident:

  • Holland estimates up to 1,000 or more women as victims after receiving PIP-manufactured "M Implants," which were banned in the spring of 2010
  • The Venezuela government has also announced they will cover the costs of removal surgery
  • Officials from the FDA warned PIP in 2000 that their saline implants were substandard and did not approve use in the US (it further disapproved PIP's silicone implants as well due to safety concerns)

The growing number of potentially affected patients has now spread to even more countries, making this a global medical issue.  Let's hope that the number of now estimated 300,000 patients affected does not grow further. 



Photo Credit:  GlobalPost and Daily Mail