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Early Surgitek Gel-Filled Prosthetic Systems
By P. Blais
Perras / Papillon Variants
Product History:
The Surgitek line of mammary implants began with the Perras-Papillon prosthesis. It appeared first in investigational and prototype forms circa 1969-70. Formal marketing began in January 1971 with a production version incorporating unusual mold designs.
Early items copied the basic technology of competing products and were generic equivalents of existing popular designs such as the Dow Corning products of the sixties. Later versions incorporated important changes.
General Electric silicone materials as well as other unconventional materials intended for general industrial use were used for some of the products until about 1975-77. Dow Corning elastomers, fabric-reinforced sheets and silicone gels are also found in some early issues. There were significant variations from item to item and production techniques were crude. Many items recovered incidental to explantation exhibit readily evident assembly defects which suggest poor Quality Assurance practices and unskilled technical personnel. Early molds for the Perras-Papillon affected the design of other prostheses made by Surgitek. Such molds were evidently modified and recycled to produce other types of prostheses such as early versions of "Snyder" and "Georgiade" introduced circa 1973-75. Thus, the Perras-Papillon had significant impact on Surgitek's technology as it was a precursor and influenced much of their product line.
The Perras-Papillon designs were made in multiple variations and some differed markedly from other products of the time. Classified as oval or contour prostheses, they were actually 'pseudo-anatomic' configurations. Product inserts prominently discussed the unusual shape which was claimed to replace and reproduce the natural shape of the breast gland including the axillary projection (Tail of Spence). Early versions were 'polarized' in the sense that implants were made in both a right hand and left hand version but the differences were subtle and it was not always easy to differentiate the right from the left.
The Perras-Papillon design appears formally in a patent filed in 1970 credited to two plastic surgeons from Montreal, Canada. The patent, granted in 1972, was assigned from the outset to the Medical Engineering Corporation (MEC): The patent claims address primarily anatomic and morphologic issues and offer little insight on material selection, durability aspects and criteria of suitability of raw materials. In the trade, the implants are considered as derivatives of contemporary Dow Corning "Cronin" designs of the early-seventies. However, manufacturing techniques, shell construction and method of use differed significantly and imparted special risks to the products.
The commercial versions of the Perras-Papillon had shells made from Bisphenol A polycarbonate-polysiloxane block copolymers. This is an elastomeric substance with properties unlike classical 'silicones'. It entered medical implant commerce through MEC on the basis of a small number of animal tests performed circa 1972-75. Subsequent evaluation of the product revealed its vulnerability to degradation within tissue and the product was abandoned. However, it remained as part of the Perras-Papillon until the mid-seventies.
The most evident characteristic of the Perras-Papillon is the complex array of fabric-reinforced elastomer parts. There is evidence that adhesives were used to reinforce and seal the shells at selected points. This became necessary because of the poor mechanical properties of the shell material which required a large mold extraction opening on the posterior side, leaving a cruciform aperture. The gel fill hole had an overlay consisting of a separate reinforcement disk. It provided closure and reinforcement for the gel fill hole and the posterior area. The adhesive sealant is believed to have been used to complete closure after filling the prosthesis with gel precursor. The gel composition appears to have varied over the years, the first versions containing very fluid, oil-like materials.
Even later versions with cohesive gels had problems. The substances appeared unstable and reverted to reactive oils with time, in particular when there was leakage or ruptures which allowed contact with tissue and fluids. The shell walls had distinct tactile characteristics unlike conventional silicones of the early-seventies. This material was a comparatively brittle substance with limited elasticity. It creased, puckered and pleated sharply to form prominent protrusions. Some later versions had thin anterior walls but most of the Perras-Papillon were thick shelled. The polycarbonate-based polymer did not tolerate institutional sterilization, in particular steam sterilization.
In vivo, the shell material degraded rapidly and embrittled leading to marked changes in durability. The substance evidently hydrolyzed under mildly basic pH and mechanical failure followed upon a few cycles of flexing. Ruptures took place early at stress points such as patch and reinforcement edges and the material spallated into fine fragments as opposed to rupturing through fatigue or tear propagation. The posterior side had an array of fixation fabric parts. Unlike contemporary articles, the fabric was a velour-like material with marked fibrotic properties. Strips of this material were bonded to the posterior side at the periphery (equator) enhancing the vulnerability of the device by concentrating stresses at its weakest and most erosion-prone area.
Several variations were sold until the late-seventies. The products were not widely used except by a small number of surgeons directly connected with the development and marketing of the devices. The largest concentration of users is located in Montreal, Canada where the conceptors of the device practiced. The items were withdrawn from the U.S. market circa 1979. Stocks were not recalled and surplus items were evidently dumped in offshore markets. For example, the Perras-Papillon implants were introduced in Norway in 1980 well after the withdrawal from the U.S. market. A similar situation developed in South Africa where the implants were distributed for the first time in late-1979. There appears to be no public domain material or publications on the performance of the product.
Transcripts of symposia and lectures of the sixties and seventies do not show any major presentation regarding studies on the Perras-Papillon. A very small number of explanted devices have been recovered. They are habitually heavily degraded and users exhibit singular pathological profiles unlike those of other breast implant patients.
Most of the Perras-Papillon devices perforated and ruptured early and users were compelled to have the devices removed for medical reasons. Devices with spallated shells are habitually recovered. Tissue proximal to the prosthetic site show distinct inflammatory reactions that subside during the late phase.
Tissue necrosis and extreme forms of intracapsular and interstitial tissue mineralization follow. Early shell perforation leads to grossly contaminated breast tissue and extracapsular oily granulomata. Large plaque-like entities with sharp edges develop at the capsule interface further destroying the shell, traumatizing the surrounding tissue and releasing fine particulate debris within the breast area.
Pathological conditions encountered in long term users are similar in some instances to what is encountered for subjects who received adulterated silicone oil injections. Such patients present with advanced stages of breast diseases and unaesthetic presentation including palpable anomalies. Resection reveals large granulomatous areas incorporating oil, fabric and comminuted shell fragments.
Contentious Issues:
The origins of the Perras-Papillon prosthesis and the exact time it entered commerce are not well documented. Fragmentary records support the belief that significant quantities of the product were distributed before 1971 in the context of pre-commercialization studies and unsanctioned clinical trials.
Areas in need of elucidation include the number of implants distributed on a complimentary basis or as part of clinical trial or commercial promotion campaigns prior to January 1971 the number of implants released worldwide after January 1971, licensing agreement for patent(s) with the conceptors,, the sub-contractors involved in the fabrication of early versions, fabrication and Quality Assurance protocols, Lot History records, the identity, location and remuneration of physicians engaged in clinical trials, clinical trial reports, adverse reaction reports, early documents on incorporation, dissolution, mergers and trademark registration affecting precursors of Surgitek and MEC.
Corporate Outline:
Surgitek is a trade name of the Medical Engineering Corporation (MEC) of Racine, Wisconsin. The corporation was formally created in 1969 from precursor fragments. In the early-seventies, MEC was an independent manufacturer engaged in the fabrication of cardiac and urology products. The product line included cardiac valves such as the Beall and Cromie designs as well as plastic and reconstructive surgery products.
A line of commercial plastic and aesthetic surgery implants was developed circa 1970; it included early mammary implants such as the Perras-Papillon and conventional silicone gel-filled devices as well as combined saline-gel prostheses similar to items commercialized by Dow Corning and Heyer Schulte. The line was later broadened to include saline-filled implants and tissue expanders. In late-1982, the facilities were sold and MEC became a wholly-owned subsidiary of Bristol Myers.
In 1988, MEC acquired the plastic surgery business of Cooper Surgical in Paso Robles, California, a controversial manufacturer of a competing line of products. The primary products of this group included the foam-covered implants which then became part of the Surgitek product lines. Difficulties arose almost immediately and continued until termination of production in September 1991.
Divestiture of the plastic surgery products business took place in September 1992. Production equipment was sold to unknown purchasers and the tradename SurgitekTM was acquired by the Cabot Corporation.
Bristol Myers continued to provide post-market support until merging with Squibb Pharmaceuticals circa 1992. It is understood that Bristol Myers Squibb is the continuing commercial entity responsible for post-market activities, litigation and follow up on Surgitek products.
Collateral Corporate Issues:
The history of MEC and Surgitek is interlaced with events of the sixties. There are connections amongst developers of its products, suppliers of raw materials, clinical consultants, product conceptors and promoters. This strongly suggests that the implant industry of the sixties had a small number of common ancestors.
Of particular significance is that conceptual errors and adverse events associated with products of the seventies and eighties have their roots during the sixties. Illustrations of relevance to Surgitek/MEC include the following highlights. The Beall and Cromie cardiac valves were developed in the sixties at the Baylor Methodist Hospital in Houston, Texas.
They were the outcome of a project linking Surgitool, a division of Baxter Travenol, a precursor of Baxter Healthcare and surgeons at Baylor. These valves were withdrawn in the late-sixties after service failures alleged to have been due to errors in design, material selection and assembly methods. Modified versions of these valves continued to be sold by Surgitek/MEC up to the late-seventies.
Baylor Methodist was also engaged in the development of the "Cronin" implant on behalf of Dow Corning, a raw materials supplier to Surgitek/MEC. Baylor was involved in the development of ProplastTM, another controversial implant material promoted by Dr. Charles Homsy, the founder of the Vitek Corporation.
ProplastTM was marketed through Dow Corning and its successor Dow Corning Wright until the mid-eighties. Vitek emerged as a major public health issue in the early-eighties in connection with faulty implants used mostly in the jaw area. The episode culminated in large scale litigation involving a large number of severely injured users. Vitek reincorporated some of its assets in NovaMed. NovaMed continued in the eighties as a breast implant manufacturer and is believed to be a strong factor in the European marketing of cosmetic surgery products.
In 1999, NovaMed and Inamed, a successor to the 3M implant operation of the seventies and eighties formed an alliance for the distribution of cosmetic surgery implants.
Reference Materials:
1. "MEC Operating Manual" (MEC Document Control release date of May 9, 1980)
2. "Market History", "Dates Of Product Introduction And Obsolescence" (MEC Document)
3. U.S. Patent No. 3,665,520 assigned to MEC
4. Bristol Myers' Stipulated List of Products; "Perras/Papillon Design Mammary Implant"
"Perras/Papillon Design Mammary Implant"
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TMJD_SAFE_HAVEN_4_LIFE_ISSUES · TMJ SUPPORT GROUP
This TMJD Support Group is intended to be a Safe Haven and provide a place where people with TMJ pain can come and offer and receive support from people who know what they are going through. This is not a medical group and we do not have medical degrees or medical backgrounds. However, with the variety of members in here, there is bound to be someone who has been there and done that and can answer your questions.
This group is in memory of Debbie Ward whom suffered from TMJD & died of unknown causes.
There are many types of members with TMJD. Some have been treated medically, some treated with various splint therapies and physical therapies as well as some with surgical treatments ranging from Arthroscopy to full jaw joint replacements. Everyone with any degree of TMJD or has a family member that deals with it is welcome to join and offer and receive support that we all so badly need to get through each day with the pain we have to live with.
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