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 impl...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news

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Conclusions Polyurethane implants seem to be more resistant to radiotherapy damage, whereas silicone prosthesis showed more structural, mechanical, and chemical modifications.
Source: Annals of Plastic Surgery - Category: Cosmetic Surgery Tags: Research Source Type: research
ConclusionSiliconomas develop as a result of implant rupture and present with many of the signs and symptoms of breast cancer. The majority of patients should undergo surgery for symptom relief or to rule out cancer.
Source: International Journal of Surgery Case Reports - Category: Surgery Source Type: research
ConclusionInitial and weekly x-ray acquisition combined with daily surface imaging seems adequate both for routine PMRT positioning and to monitor potential changes in the treatment area. The limits of the surface imaging system, however, need to be better specified among patients without breast implants or in those with large implant reconstructions.
Source: Practical Radiation Oncology - Category: Cancer & Oncology Source Type: research
ConclusionSiliconomas develop as a result of implant rupture and present with many of the signs and symptoms of breast cancer. The majority of patients should undergo surgery for symptom relief or to rule out cancer.
Source: International Journal of Surgery Case Reports - Category: Surgery Source Type: research
ConclusionInitial and weekly x-ray acquisition combined with daily surface imaging seems adequate both for routine PMRT positioning and to monitor potential changes in the treatment area. The limits of the surface imaging system, however, need to be better specified among patients without breast implants or in those with large implant reconstructions.
Source: Practical Radiation Oncology - Category: Cancer & Oncology Source Type: research
Conclusion: Six-year results from 438 women show that the structured breast implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
Source: Plastic and Reconstructive Surgery - Category: Cosmetic Surgery Tags: Cosmetic: Original Articles Source Type: research
The history of breast implants includes important technological breakthroughs, but also safety controversies such as the 1992 FDA moratorium against silicone, the 2010 PIP implant scandal, and the 2015 Silimed ban.1 –3 Nevertheless, the popularity of breast augmentation continues to grow, and millions of patients receive breast implants each year.4
Source: Journal of Plastic, Reconstructive and Aesthetic Surgery - Category: Cosmetic Surgery Authors: Tags: Editorial Source Type: research
Background: Increased surface area of mammary implants is suggested as a causative agent for the development of biofilms, which may lead to capsular contraction. The aim of this study was to quantify the surface areas of round implants of different textures and examine how these data can be interpreted with regard to clinical observation. Methods: Surface areas of textured round breast implants were calculated from previously reported confocal scanning microscopic assessment, and dimensions sourced from 3 breast implant manufacturers (McGhan, Mentor, and Silimed). Statistical comparisons were made between manufacturer...
Source: Plastic and Reconstructive Surgery – Global Open - Category: Cosmetic Surgery Tags: Original Article Source Type: research
ConclusionsThe epidemiology of the disease strongly suggests that the vast majority of cases are not a cancer that will inevitably progress without treatment. The findings presented in the manuscript provide supportive clinical evidence. Consequently, an alternative view of BIA-ALCL with implications for research, diagnosis and clinical management needs to be considered.Level of Evidence IVThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authorswww.springer.com/00266.
Source: Aesthetic Plastic Surgery - Category: Cosmetic Surgery Source Type: research
CONCLUSION: Breast prostheses recently contaminated with Staphylococci, frequently involved in peri-prosthetic breast implant infection and capable of producing biofilms, can be efficiently decontaminated by the procedure used in this study. Our decontamination procedure did not alter the surface structure of the prostheses. This decontamination procedure could allow reinsertion of an infected implant when peri-prosthetic infection occurs early after breast augmentation or breast reconstruction and when a salvage procedure is indicated. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence t...
Source: Hand Surgery - Category: Surgery Authors: Tags: Aesthetic Plast Surg Source Type: research
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