Table of Contents
The After-effects of Poly Implant Prothèse (PIP) Scandal is Threatening and Long
•The Poly Implant Prothèse (PIP) implant scandal, which came to light in 2010, instigated the government of the United Kingdom to launch several reviews with the aim of ensuring patient safety in the large private cosmetic interventions industry.
•Recognising the need to regulate devices, practitioners, and service providers—in addition to the incorporation or structuring of a governing body specific to these requirements—the Secretary of State for Health called for a review to be led by Sir Bruce Keogh.
•This review was announced in January 2012 and was completed in April 2013.
•The outcomes of this review included:
oTightening of regulations around distribution of implants and dermal fillers
oCertification and inspection of service providers
oImplementation of a national implant registry
oCertifications for practitioners among others recommendations
•The announcement and implementation of these regulations are expected to negatively impact patient volumes in late 2013 to 2014, eventually stabilising over a year.
•The impact on service providers and suppliers in the next xx to xxyears includes the consolidation of market participants aiding Tier I market participants (both suppliers and service providers), and the possible elimination of smaller market participants in service provision and supply.
•Due to the expected increase in the pricing of supplies and additional costs of compliance, profit margins per intervention are expected to decline for Tier I service providers.
•However, the expected shift in patient volumes from Tier II and Tier III to Tier I will supplement this decrease in profit margins.
•Continued growth is forecasted for Tier I service providers and suppliers in the cosmetic interventions industry in the United Kingdom (UK) over the next xx years, at the expense of smaller market participants who will be unable to cope with the costs of compliance.
The PIP implants were manufactured by the French company Poly Implant Prothèse, SA, which was founded in 1991, was liquidated in 2011. In 2000, the Food and Drug Administration (FDA) stopped the sales of these implants due to quality reasons. From 2001, the company manufactured implants with industrial grade silicone, and sold these implants under the Rofil-M brand to Latin America and Europe. The implants were prone to rupture, leakage, and even contributed to a reported increased incidence of cancer. A lower grade silicone was used to make implants fraudulently which was deemed as a violation of regulatory approval.
In 2010, the French regulatory authorities notified the Medicine and Healthcare Products Regulatory Agency (MHRA) of the inconsistencies in implant production, and recommended removal of all PIP implants. The French government recommended that all PIP implant users have their implants removed or replaced in December 2011, a process which was funded by the country’s public healthcare system. Following this, the PIP implant issue received significant media attention. The Department of Health (DH) in the United Kingdom reviewed the cases and concluded that there was no causal link between the fraudulent implants and breast cancer. However, an outline was provided on the help that would be provided to women using the implants. Service providers were asked to offer the removal or replacement of implants, or follow-up examinations, if patients chose not to have them removed. The recall was mirrored by most countries including Germany, Italy, Sweden, Netherlands, Finland, Estonia, Czech Republic, and many countries in Latin and South America.
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