PIP (Poly Implant Prothese) Implants

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The history of breast augmentation surgery has followed the tempestuous path of alternating progress and hurdles, with a large helping of hysteria served up on occasion. This media and socially driven publicity is often very well founded and the PIP debacle is one such occasion. At times however, it is more furor than fact, which may or may not improve our outcomes, but always does improve patient knowledge and participation.

 Despite this, between five and ten million woman worldwide have opted for breast implants. The quandary is to separate true bad effects from the dangers of over-enthusiastic interventions, and this may only become apparent after a period of time. But at times we cannot afford to wait for this clarity, thus the unnecessary surgery. To understand the present problem, an understanding of the nature of cohesive silicone filler gel of the modern prosthesis must be appreciated. Silicone is a term for the many usable forms of the element silicon, and is a polymer, similar to the many polymers of carbon based oil, such as plastics and nylons. The basic building block is dimethylsiloxane, with the average chain length influencing firmness.

This is known as cohesion, and a highly cohesive, gel-like filler causes minimal reaction if it escapes from an implant and oozes into human breast tissue. Some silica is added into the mix to increase stability and firm texture, but this is precise and must be of the pure, non-crystaline form, otherwise it is like sand. This, along with many other checks, makes for medical grade silicone which is the most commonly used, least reactive and most studied medical device in history. Poly Implant Prothese (PIP) was a prosthetic manufacturer based in France, and selling around 400 000 prostheses around the world. Sales went mainly to Europe, the United Kingdom and South America, with initial sales to USA later to be curtailed after concerns about manufacturing standards. South Africa was affected to a lesser extent, with a possible total of 15 Plastic Surgeons ever having implanted PIP prostheses between 1995 and 2009. The implantation statistics amongst so-called “cosmetic surgeons” is unknown. The real difficulty arises in that a reputable company presents a European standard product with all the official approvals to an implanting surgeon with the assurance of quality and good back-up, as well as track record in foreign market places. There is certainly no visual or palpable difference that could warn of future problems.

The reason that such a failure of checks arose in the case of PIP was that the system in place in Europe for the sales of medical devices requires a check by an independant Notified Body, or a facility as appointed by the competent/regulatory authority of a respective country. The company attempting to manufacture a product can choose any Notified Body in Europe. This then achieves a CE mark, and the device can be manufactured and supplied in perpetuity with no further checks. In the case of PIP, the CE mark was received from TUV Rheinland in 2000. Subsequent deviations from good practice by the unscrupulous Mr. Mas could never be noted under this system unless problems arose with these devices, which subsequently happened.

 As always with such emotive and contencious issues, hindsight often reveals many interested parties revealing their concerns at the time. However, this must be placed in the context of an already highly charged topic that will always have many pro- as well as antagonists with their own opinions and agendas.

 In truth, the main concern is increased rupture rate of PIP prostheses, as well as a much higher inflammation (tissue irritation and reaction) potential of the industrial, more liquid silicone filler. This is more akin to the older filler silicone found in the prostheses of the seventh decade of the last century with similar reaction and possible spread into all contiguous areas of the breast.

 Notable also is the attrition rate as found in even the highest quality prostheses where a certain, if extremely low, percentage of implanted breasts will show rupture over time for a variety of reasons. Mostly, these ruptures are sheltered within the scar tissue naturally occurring around the prosthesis, known as the capsule. The silicone is cohesive, and stays in the capsule thereby maintaining the shape and size of the breast, as well as showing no symptoms. Even here, an ethical debate arises amongst Plastic Surgeons as to whether to remove such asymptomatic ruptures or not. This seemingly obvious choice must be weighed against the cost, the risk of an anaesthetic, as well as the increased internal scarring that results from such a removal or explantation.

 Such issues have been considered by both the British NHS task Group under Sir Bruce Keogh, as well as the Association of Plastic and Reconstructive Surgeons of South Africa. At present, the prudent advice appears to be a policy of removal of any symptomatic ruptures, as well as all severe, unallayed fears with associated dysphoria, with a program of careful surveillance and action as called for. This is obviously under constant review, and may require alteration with a policy shift in the future as new information and outcomes are revealed. The caveat is a high index of suspicion with yearly ultrasound checks, and constant surveillance. This is nothing outlandish, as mammogram and ultrasound checks are vital for yearly cancer surveillance irrespective of breast augmentation surgery or not over a certain age.

 Other European bodies differ in opinion, as they recommend removal of all PIP implants as a matter of course. Their rational is the unusual presentation often seen with rupture of these non-medical grade silicone prostheses. The usual presentation of prosthetic rupture varies from those remaining entirely assymptomatic, to the complaint of a hardened, possibly painful breast. Most often, a worsening cosmetic result leads to a visit to the Plastic Surgeon. This is due to a hard round capsule surrounding the broken implants which often moves up the chest and shows upper breast hardness, with the natural breast falling off the front giving an exaggerated droopiness.

 PIP ruptures, in contrast, often yield an uncharacteristic red, uncomfortable angry breast. On removal of the rupture at surgery, marked inflammation is caused by the thin silicone filler causing a marked reaction by exposed breast tissues. Hardened capsule is almost entirely absent. Take-up of micro silicone particle to regional armpit lymph nodes is more common, and surgical removal may be necessary. European Authorising Bodies therefore feel that the surgical risks of removal of those that have no problems are exceeded by the severity of the reaction of those that have ruptured. Consideration is also given to the higher, though as yet unknown, rupture rate.

 Either way, rational evidence based directives should trump hysterical snap decisions. This is where a trusted Plastic Surgeon will decide in conjunction with an informed patient, and not be afraid to change protocol as new information comes to light.

Watch out for...

  • Redness and inflammation far out of proportion to that expected.
  • Any associated pain.
  • A breast that remains without evidence of a capsule, and is therefore relatively soft.
  • Any abnormal findings on ultrasound or mammogram.
  • Axillary lymph nodes enlarged or painful.
  • General signs of rupture such as size or shape change because not all PIP prostheses had substandard silicone.

And lastly

The costs of surgery are substantial. Despite the fact that nobody would like to bear this cost, somebody or some organisation will have to. The manufacturing company, Poly Implant Prothese, has ceased to exist with the ignoble Mr. Mas having been arrested. As no financial assistance is forthcoming from this avenue, and no cover from State or most medical Insurance plans for this removal and replacement can be relied on, the cost will essentially be borne by the patient. Individual surgeons, Hospital theatres as well as alternative prosthetic manufacturers should in good faith be able to negotiate an affordable, reasonable plan thereby solving this problem.
Discuss this frankly, as you would your medical concerns.

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