Our concerns
1. The PIP implants were found to contain a higher proportion of small-sized molecules D4, D5, D6 than the norm.8 D4 (octamethylcyclotetrasiloxane) was identified as an endocrine disrupting chemical (EDC) of ‘high concern’ in 2007 by a report commissioned by the European Commission entitled ‘Study on enhancing the Endocrine Disrupter priority list with a focus on low-- production chemicals’.9 The effects of low doses of such chemicals, particularly on the developing fetus, have been well documented.10–13 While most regulatory levels of impurities in breast implants are considered acceptable in the range of a few parts per million, Le et al. 14 showed that EDCs are capable of affecting developing neurons in vitro at concentrations of less than one part per trillion. Considering these known risks and the fact that most women receiving breast implants were of reproductive age, we would expect the MHRA and the Department of Health to fulfil its duty of care and thoroughly investigate these risks as well as provide full information to patients..
2.2. The report bases much of its evidence upon animal data rather than readily available human-based methodologies, such as toxicogenomics using human cell lines, which are ideal platforms for studying the effects of trace quantities of impurities on gene expression levels.15...............
3. The MHRA is the UK government agency responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe..Read more
The PIP Breast Implant Scandal: Criminal Medicine and Discourses of blame
When the PIP scandal first broke in the UK a representative from theBritish Association of Aesthetic Plastic Surgeons (BAAPS) told TheTelegraph that ‘many British women would have had them implanted when they travelled to clinics in Eastern and Central Europe for cut- price breast enlargements’ (Anon 2012).read more
The PIP Literature Review: June 2013
UK News 18 June 2013 – PIP ACTION CAMPAIGN reproduces peer-reviewed studies to inform all those treating victims of the P.I.P. Implant fraud. British women are left frightened and confused by the statements from the DoH and the MHRA. Referring to the Keogh Final Report of 18 June last year, they say:
Women want GPs, doctors & surgeons to review the literature for themselves.+
“the advice from our experts still stands”5 June 2013+
Here you will find brief details of recent peer-reviewed studies, case reports and essays, with links to the full articles. If you are unsure that the doctor or surgeon treating you is as well-informed about the developing P.I.P. Breast Implant health crisis as you would like. Just click the link below, print a copy of The Literature Review June 2013 and pass it on!
The Psychological Impact of the PIP Breast Implants Scandal on a Cohort of UK Women
It has been reported that 400,000 women worldwide received PIP implants consisting of non-manufacture grade silicone. The associations of this prosthesis with high rupture rates and cancers such as anaplastic large cell lymphoma have the potential to inflict serious psychological trauma on a cohort of women who are already vulnerable following a diagnosis of breast cancer In the UK there was a huge amount of media publicity following the outbreak of the scandal that led to thousands of women demanding information from the medical community. This study was undertaken to assess the risk of developing psychological disorders in a susceptible group of women. Read more;
Chemical and biochemical composition of late periprosthetic fluids from women after explantation of ruptured Poly Implant Prothèse (PIP) breast prostheses
Highlights
• PIP breast implants have been implanted in at least 300,000 women in the world.
• PIP implant rupture is associated to a yellowish fluid.
• The composition of this fluid was unknown.
• Rising concerns from defective shell rupture and silicone spread through this fluid. more info;
PIP silicone breast implants: Rupture rates based on the explantation of 676 implants in a single surgeon series
Conclusions; Our paper has confirmed high rates of PIP implant failure in the largest published series to date. The significant difference in rupture rates between implants inserted prior to 2003 and those after this time supports the view that industrial silicone was used in the devices after 2003. Implants are more likely to rupture if inserted in the sub muscular plane compared to the sub glandular plane. USS is highly effective at detecting rupture in PIP implants and loco-regional spread is high compared to other devices. We believe this paper provides hard data enabling more informed decision making for patients, clinicians and providers in what remains an active issue affecting thousands of women. more info;
• PIP implant rupture is associated to a yellowish fluid.
• The composition of this fluid was unknown.
• Rising concerns from defective shell rupture and silicone spread through this fluid. more info;
PIP silicone breast implants: Rupture rates based on the explantation of 676 implants in a single surgeon series
Conclusions; Our paper has confirmed high rates of PIP implant failure in the largest published series to date. The significant difference in rupture rates between implants inserted prior to 2003 and those after this time supports the view that industrial silicone was used in the devices after 2003. Implants are more likely to rupture if inserted in the sub muscular plane compared to the sub glandular plane. USS is highly effective at detecting rupture in PIP implants and loco-regional spread is high compared to other devices. We believe this paper provides hard data enabling more informed decision making for patients, clinicians and providers in what remains an active issue affecting thousands of women. more info;
The “PIP scandal” – Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report
Clinical Case Study
We realised the hitherto lack of awareness of the connection between PIP and Rofil, when a 27-year-old patient presented herself to our department in July 2010. She had undergone aesthetic surgery in another clinic 3 years ago for breast augmentation with 350 ml Rofil bilateral implants. The patient now indicated acute infection signs of the right breast with fever and local swelling, as well as axillary lymphadenitis and elevated inflammatory markers. A suspected ruptured implant and periprosthetic infection was confirmed by MR imaging. Surgery was immediately performed. Thin liquid pus was removed ([Fig. 1]) from the area of the implant, but a causative pathogen could not be established. A tear was visible on the side of the implant facing the thorax ([Fig. 2]) as well as a diffused gel seepage (bleeding). A histological analysis indicated a florid purulent, partly abscessed lymphadenitis with silicone traces in the excised lymph nodes ([Fig. 3]). Read more
The PIP mammary prosthesis: A product recall study
Introduction; Concerns about the durability of silicone breast implants manufactured by Poly Implant Prothèse (PIP) have been expressed for several years prior to their formal withdrawal from the market in March 2010. Although precise details of what elements were at fault remain unclear, concerns have been raised about both the elastomer and the filler gel. Media speculation has focussed on device safety, longevity and, recently, a possible association with lymphoma, specifically anaplastic large cell lymphoma (ALCL). There is however, no actual data concerning these implants with which to guide and inform when concerned patients seek advice.Read more
Analytical investigations on elastomeric shells of new Poly Implant Prothèse (PIP) breast and from sixteen cases of surgical explantation
June 2014
Poly Implant Prothèse (PIP) Incidence of Device Failure and Capsular Contracture: A Retrospective Comparative Analysis - Springer
Chemical and biochemical composition of late periprosthetic fluids from women after explantation of ruptured Poly Implant Prothèse (PIP) breast prostheses
Experts dispute conclusion of PIP breast implant scandal investigation
9 May 2013
Disputing this the authors point to evidence showing that the PIP implants were found to contain a higher proportion of a group of small-sized molecules than the norm, including one referred to as D4 which has been identified as an endocrine disrupting chemical (EDC). In low doses, EDCs are known to cause damage to a developing foetus Read more
