PIP breast implant scandal: A story that triggered change

In the healthcare industry, stories of patient harm can sometimes be the impetus for positive change. This was the case with the PIP breast implant scandal, where cost-cutting decisions that resulted in injuries eventually led to major regulatory updates.  In 1965, plastic surgeon Henri Arion introduced breast implants to France.  Jean-Claude Mas, a former butcher turned medical sales representative, and Henri Arion worked together in this field; following the death of Arion in a plane crash, Mas went on to launch Poly Implant Prothese (PIP) in 1991. It was the beginning of a company that would produce approximately two million sets of silicone breast implants over the course of a 20 year period and in its path, create a global health scare and shape medical device regulations. The silicone-based scandal came about when PIP implants made from a cheaper, industrial-grade silicone (that was not approved for medical use) were rupturing at a rate that was double the industry average. When compromised, the silicone gel was known to cause inflammation and possible scarring, and these implants continue to raise questions over the possibility of other harmful long-term effects. The timeline below summarizes the key points of the complex story: Timeline: 1991: PIP launched by Jean-Claude Mas. 1992: US Food and Drug Administration (FDA) calls for voluntary moratorium on use of silicone gel – Implants and implant sales are halted in the US. 1994: PIP sells hydrogel implants. 19...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news