RISKS FROM IMPLANT REUSE - AN UNSANCTIONED PRACTICE
The reuse of any implant under any condition is not appropriate. Firstly, once implanted, most implants acquire tenaciously-bound impurities which cannot be removed under field conditions. Secondly, the surgery and even a brief period of use severely compromises the durability of the implant. Thirdly, exhaustive decontamination, disinfection and sterilization of implants is a specialized series of procedures suitable only for laboratory and industrial facilities. Even the momentary removal of an implant to resolve a complication with subsequent reinsertion is illogical as most often the cause of the implant complication resides within the implant and most probably will carry over as it is reinserted. Therefore, any such procedure is self-defeating and, on detailed analysis, cannot be justified in terms of actual manipulative cost. At any rate, the risks are so elevated as to invalidate any possible saving.
Nevertheless, the practice is widespread in plastic surgery and was at one time so common in plastic surgery of the breast that even manufacturers complained of lost revenues. There are no policies or standards that would apply to the refurbishing, reconditioning and clinical reuse of medical devices of this kind. There has been no cohesive survey on the extent of the practice but an estimate based on random sampling of records, suggests that it may have reached as high as 30 percent of all cosmetic breast augmentation procedures in certain metropolitan areas.
The reuse of complex medical/surgical devices and diagnostic systems with brief contact time may be tolerable or even necessary if the items are too costly to discard and suitable technologies exist that allow safe reconditioning and reuse. However, implants, in particular cosmetic surgery implants, are not in that category. These are low cost items; they cannot be reused under any condition. The rationale is that structural features of these devices render them extremely fragile. In addition, exhaustive cleaning from endogenous substances, tissue, adventitious micro-organisms and proteinaceous contamination create a very elevated bioburden. They cannot be satisfactorily cleaned and sterilized by any process. Furthermore, the devices are inherently weak and a single cycle of use creates major shell and valve damages which will inevitably cause premature failure of the product.
A double lumen device intended for breast implantation is the most extreme example. It has an internal fluid compartment which cannot be accessed by the cleaning and disinfection process. Even when new, the valve, which provides for filling of the item, is not secure; the product generally fails by a combination of infective, inflammatory and material deterioration processes and is normally left with a perforated outer shell. Any attempt at recycling this device into the same patient, or a new patient, will reintroduce the same problems into the breast pocket and will account for much of the patient’s subsequent misadventures.
Paradoxically, such procedures are still condoned by the plastic surgery community. Surprisingly, they were implicitly supported by most of the manufacturers, at least prior to 1987. Virtually all product inserts described detailed procedures to perform "resterilization of contaminated implants". These gave instructions on recycling which could be easily interpreted as supportive of the practice. After 1985, some manufacturers included contra-indications or statements indicating that the products were "for single use only".
The rising popularity of foam-covered implants in the eighties introduced additional risks to recycling. These devices lost most of their coatings during the first few months of implantation and, as a result, the devices were dramatically changed. During the aging process after the implant had been in situ for some time, porosity developed in the adhesive coating leaving deep, fine channels ideally suited for proteinaceous debris and micro-organisms. These cavities would be idealized harbors that would resist exhaustive cleaning by any known technique short of stripping the totality of the coating. Chemical alterations in the adhesive were also present thus changing the biocompatibility characteristics of the surface. Finally, the sterilization process would severely impair the adhesion between the elastomer coating and the shell material thus facilitating widespread debonding and production of large fragments of debris.
Any reuse predicated on the basis of "salvage" of an implant is illogical from any point of view. A breast implant is a low cost product and most designs have deep interstices that defy exhaustive cleaning. Microbiological controls on resterilized items of this kind are virtually inapplicable because of the wide variation from product to product and even from items of the same production. Given that the devices were mechanically inadequate from the onset, any supplemental process intended to remove foreign biological matter and destroy established microbiological colonies would impart further damage to the item and compromise its mechanical integrity to an even greater degree that it already was.
Thus, there is no probability that resterilization of a contaminated breast implant could lead to a clinically useful product. Even if it had been possible to develop a process which was sufficiently lethal to bring the microbiological safety of the item within the requirements of current surgical demands, the costs would have far exceeded the market value of a new item of the same kind.