Thursday, August 14, 2014
THE PIP DEBACLE OF 2012
Emerging Problem -
Medical services relating to adverse events from breast implants have continually increased, with attendant costs. Demand for such services will reach a crescendo as users of the controversial PIP implants undergo explantation on recommendation of national regulatory bodies. The method of implant removal is critical, not only to the long term health of the patient but to the sustainability of publicly-funded implant removal programs. Explantation must be performed by surgeons with the skill and experience to correctly remove the implants, their debris and the contaminated surrounding tissue.
A limited number of surgeons worldwide have such attributes and they will be unable to meet the demand. Individuals with failed implants are generally unsuited for implant replacement. If re-implanted, the cycle of adverse events will be repeated, in particular if the new implants are inserted into contaminated, undebrided implant pockets. Guidelines with oversight provisions must be established to ensure that the morbidity from past abuses does not continue or worsen ..Background - Poly Implant Protheses (PIP) is a France-based company near Toulon.
PIP was founded by Jean Claude Mas in 1991 and consolidated assets from several bankrupt breast implant firms. PIP has a long history of regulatory infraction worldwide and again became topical in 2010 when it declared judicial bankruptcy. French authorities investigated PIP in the context of commercial fraud, money laundering and user injury. The situation was complicated by the deaths of several officials connected with PIP and its funding agencies. The injurious potential of implanted PIP products will have repercussions on healthcare services for many years to come. This briefing addresses aspects of healthcare needs secondary to the removal of PIP and substantially similar mammary implants deemed dangerous and eligible for removal under provisions of healthcare programs.
Rationale for Action -
Corporate records establish that PIP and its precursors made more than 500,000 breast implants between 1989-2010. At least 60 countries received shipments of PIP implants. The implants were also distributed through clearing houses and via internet commerce. Based on direct examination of a significant number of explanted PIP prostheses, they did not fulfill basic safety requirements. The level of risk varies depending on the type and year of manufacture but there is no mechanism to assess which type or batch of PIP implants constitute the most acute risk. Additional concerns include product cleanliness and sterility, the haphazard and undocumented use of intermediates intended for industrial applications, falsified expiry dates, product mislabeling and compromised packaging
.Implant Recall is Problematic -
The recall of an unused implant poses minimal logistics problems and retrieval of outstanding stock can be comprehensive. However, if the product line has been in commerce for a long time, retrieval is nearly impossible as many will have been implanted. Patient follow-up then becomes key. Patient tracking is historically poor in the breast implant trades and a significant number of users will be inaccessible because of death, geographic moves or peculiarities of lifestyle. If the recall is widely publicized, a sizeable fraction of users may come forward and the decision to seek explantation becomes a personal choice. In the case of the PIP 'recall', it is probable that the overwhelming number of users will opt for explantation. Logistics of Breast Implant Removal - The removal of an implant requires a health care provider, typically a surgeon.
However, the quality of the outcome and long term consequences of the failed implantation will vary drastically depending on the surgeon's skill, experience and commitment. Incorrectly-performed explantation can leave the patient with severe and lasting adverse consequences. There is an established tradition for surgeons not engaged in plastic surgery to avoid patients who encounter complications from cosmetic surgery. Thus, individuals seeking explantation are referred back to their plastic surgeon. It is another tradition that many cosmetic surgeons are inclined to replace implants with minimal surgical debridement.
Given the number of users who may seek explantation as a result of the publicity about the PIP incident, the most' competent surgeon's -will develop prohibitively long waiting lists. Even more probable, is that marginally qualified health care providers will be pressed into service.The Technology of Implant Removal - Whereas the insertion of mammary implants is a simple task that may require as little as 20 minutes and rarely more than 60 minutes, comprehensive implant removal and tissue debridement may demand in excess of 150 minutes.
When an implant has been in place for more than a year, an enclosure of specialized tissue, termed 'capsule', forms to insulate the chest structures from the foreign substance. At explantation, this capsule must be removed to avoid long term complications secondary to a failed implant. For implants in situ for more than five years, the capsule will of substantial thickness and willoften adhere tenaciously to chest muscles. Thus, explantation must include the simultaneous removal of the implant with its surrounding capsule, preferably as if it were a single, tumor- like entity. This procedure, termed 'extracapsular capsulectomy' or 'excerese en bloc', is the standard of care. However, it is a demanding task on the part of the surgeon and requires expertise. The number of surgeons with such experience is limited. Conversely, the removal of an implant without capsule removal is propitious for recurrent and more severe symptoms.
Expected Condition of Removed PIP Implants - PIP implants were optimized for minimal cost. With this perspective, shells were used for multiple applications. For example, implant shells filled with saline, hydrogel or silicone gel were considered interchangeable. Shell materials have different performance characteristics depending on their content.
Silicone gel-filled PIP implants employed a penetrating and strongly-interacting diluent in the gel. This diluent altered shell durability, resulting in statistically-elevated early failure rates. PIP implants filled with water-based hydrogels and saline also had poor durability characteristics.
In essence, after a dwell time of about five years, the near totality of PIP shells will have sustained rupture. Under these conditions, implant removal will present as more laborious and lengthy. Complications are also more likely, in particular for the silicone gel-filled PIP implants which contain aggressive intermediates that impact adversely on tissue. When gel contacts tissue, an inflammatory reaction sets in. With time, a composite of tissue containing finely-divided gel pockets and reactive prosthetic intermediates forms. Termed 'granuloma', these entities, which present as rubbery, reactive lumps of altered tissue, cannot be left behind as they behave as aggressive implant-like substances. Granuloma or 'granulomata' must therefore be resected to ensure a reasonable probability of returning the chest to as near a normal condition as possible. Muscle destroyed by the implant effluents or damaged during the debridement surgery must also be repaired. These considerations further increase demands on the surgical team.
Innoval Failure Analysis Ottawa, Canada K2A 2V1 January 2012