Breast Implant Claims and the Settlement Plan info
Contact: The Settlement Facility – Dow Corning Trust E-mail: firstname.lastname@example.org
Web site: www.sfdct.com
Phone Number: +1 713 874 6099
Toll free Number within the U.S.: 866 874 6099
International Toll Free Number from outside the U.S.: +1 866 874 6099
General information on the Settlement Plan is also available at the Tort Claimants Committee’s Web site at www.tortcomm.org.
Dow Corning Breast Implants
Dow Corning breast implants were the most popular of the early silicone implants used for cosmetic and reconstructive surgeries during the 1970’s, 80’s and 90’s. Although originally hailed as a miracle product to increase breast size and fullness, the silicone breast implant became a symbol of corporate liability, patient suffering, poor science and abuse of the legal system for over 20 years.
History of Dow Corning Silicone Implants
Dow Corning was founded in 1897 by Herbert Henry Dow, a Canadian Chemist. Dow Corning began producing a very limited product line consisting of potassium bromide and bleach. The company grew and expanded over many years and eventually became a major manufacturer of silicone products. Naturally, the company moved into making silicone breast implants when the demand for these products was established. Dow Corning is the second largest chemical manufacturer in the entire world and the largest producer of plastics.
Dow Corning Breast Implants Litigation
Dow Corning was one of the earliest targets of a vast number of individual and class action silicone breast implant lawsuits concerning a cosmetic surgical product or procedure. The trouble for Dow started in 1977 with one breast implant lawsuit and grew to over 20,000 by 1995. Dow Corning filed for Chapter 11 bankruptcy protection in 1995 as a result of these overwhelming financial liabilities. Many verdicts were returned finding Dow responsible for illness and health concerns faced by women who had received Dow silicone breast implants.
The Bottom Line on Dow Corning Breast Implants
The Dow Corning debacle taught medical manufacturers a valuable lesson… DISCLOSURE is crucial. Companies now disclose any potential side effects of any medical or pharmaceutical product or service; even if there is no proof that the side effect actually exists. Dow was found guilty in the media long before most litigants ever reached a court of law, due to the sincerity of most victims and defensive reaction of the company. Dow should have had a better patient education program and better explained the negative considerations involved with breast augmentation to potential patients. Although the company did eventually recover from the implant fiasco, it was eternally damaged in reputation and limited its desires to expand into riskier industries.
Posterior surface of a Dow Corning 380 series standard double-lumen implant (placed 1985), showing the most common configuration for the leaflet valve for this series (thick arrow). Just barely visible on this implant itself (but not in this photograph) were the markings “SILASTIC II 300 cc” on the round inner-lumen back patch (thin arrow).
DOW CORNING: HISTORY AND BREAST IMPLANTS
PRODUCT LINE OVERVIEW:
Medical Products Business Unit – The Early Period:
Dow Corning was formed as a result of a joint venture agreement between Dow Chemical and Corning Corporation. The targeted business included primarily silicone products for military and industrial applications. Following early publications claiming favorable results from the implantation of silicones in animals, a significant amount of these products were diverted to investigational and extemporaneous surgical usage.
Early apparent successes motivated the Corporation to undertake additional research in the late-fifties and the medical products activity was separated as a special project in 1961. Early products included gel-filled “Cronin” breast prostheses and “Swanson” flexible elastomer finger joint prostheses. By the mid-sixties, the sale of “Cronin” breast prostheses was significant. Additional products included custom-made investigational implants and pharmaceuticals based on silicone chemistry.
Plastics and adhesives targeting the medical products industry were also developed at that time. These included “RTV”-based elastomers sold as liquids or pastes as well as pre-finished shapes such as tubing and sheeting for other medical devices. Some of these projects led to commercial products. A family of cranio-facial implants based on solid elastomeric silicones evolved during that time. Components for hand reconstruction such as the Swanson Lunate implants were also commercialized. Concurrently, the breast implant business also grew to a major activity.
Concurrently with this program, Dow Chemical Corporation undertook a program for biological and biochemical uses of silicone-derived products. To this end, a Biosciences Division was created to provide a research base for such applications. The program meshed intimately with Dow Corning’s activities and eventually joint programs with other pharamaceutical firms such as A.B. Kabi of Sweden and Lepetit S.A. Of Italy investigated biological effects of silicone derivatives deemed to have interesting pharmacological properties. Phenomena such as tissue interaction with fluid silicones, systemic administration of silicone derivatives for fertility control, silicone oils as carriers agricultural chemicals and pesticides as well as military applications of silicone-derived substances were investigated. In the late-sixties, parts of these programs were merged into Dow Corning’s activities and several key staff workers transferred from Dow Chemical to Dow Corning.
The Late-Seventies Growth Period
In the late-seventies, the marketing of Dow Corning medical products was delegated to Dow Corning Wright Corporation, a separately-created distribution center based in Arlington, Tennessee. Offshore production of implants was also conducted in Brazil. Research and development activity was conducted in Brazil, Italy and several other offshore locations. Licences for materials were issued to other corporations. Most cranio-facial and other minority medical implants were made in Hemlock, Michigan. Sub-contractors were also employed for some types of products; for example, Cox Uphoff International fabricated components on behalf of Dow Corning up to the late-seventies.
At that time, Dow Corning acquired a sizable plastic surgery marketing staff. It advertised widely and promoted implants extensively. As a result, it retained its dominant marketing position. The firm also sold raw materials to most of its competitors and claimed to perform key research demonstrating the safety of their products and their constituent substances.
Concurrently, Dow Corning acquired distribution rights for plastic surgery products made by other manufacturers. For example, Vitek Corporation of Houston sold their Proplast implants through Dow Corning sales divisions. Domestic distribution of implantable products was originally from Midland and Hemlock, Michigan and used corporate sales staff. Offshore distribution used Dow Chemical, Dow Corning and freelance sales contractors in some countries. A few of these contractors also sold competing products concurrently. The marketing activities of the firm were split off from the main manufacturing operations circa 1980; Dow Corning Wright of Arlington, Tennessee became the primary distribution organization; rationalization of offshore marketing was also undertaken in the eighties but sale declined because of growing competition.
The last versions of the 900 were discontinued sometime in the mid eighties. They were replaced by the Silastic II Series and the MSI textured surface variants. Numerous shell failures and gel extravasations have been reported for all Dow Corning products. The mode of failure is remarkably consistent with theoretical predictions. It is fatigue of the shell in areas subject to repeated pleating/creasing and abrasion. This type of failure represents the largest cause of morbidity for the product.
Following numerous reports of adverse reactions and product failures, the FDA attempted to regulate the sector from about 1985; it introduced draft regulations for pre-market requirements on breast implants and other implantable devices deemed to constitute significant risks. Their proposals were successful following Congressional hearings in the late-eighties. Abuses in plastic surgery further precipitated events by forcing FDA action in the area of breast implantation and cosmetic injection of silicone oils.
Dow Corning terminated its production of plastic surgery products in early 1992 following the FDA’s refusal to grant a Certificate of Compliance for the Silastic II and the MSI breast prostheses. Further disengagement from the implant business took place in 1993 when the FDA later enacted a Moratorium on further use of silicone gel-based medical implants. Production and marketing of Dow Corning medical implants ceased circa 1994 and assets were evidently sold to offshore manufacturing consortia involved in medical products.
Numerous claims of injuries and adverse reactions from Dow Corning plastic surgery products were filed between 1980 -1995. In 1992, a proposal was made to consolidate some of the claims from U.S. and foreign plaintiffs into a Class Action. Similar activity took place in Canada between 1993-95. The firm entered into a reorganization under protection of U.S. Chapter 11 in June of 1995.
Distribution Practices and Offshore Activities:
Marketing practices for commercially made Dow Corning medical products varied with the years, the nature of the items and the territory. Domestic sales were initially through surgical product distributors such as V. Mueller & Co., Chicago, Illinois, Pilling Co., Fort Washington, Pennsylvania, Storz Instrument Company, St. Louis, Missouri and Edward Weck and Company Inc., Long Island City, New York. These quasi-independent firms also undertook foreign marketing. Subsidiaries such as Weck Canada and V. Mueller (an American Hospital Supply subsidiary) as well as others marketed Dow Corning medical products outside the U.S.
In Europe, the Far East and Australia, a different situation emerged. An Italy-based pharmaceutical firm (LePetit Pharmaceuticals) became a joint participant in Dow Corning and Dow Chemical medical product research and development. In the seventies, Dow Chemical emerged as the exclusive distributor of Dow Corning breast prostheses in many parts of the world. Dissent later developed amongst senior executives at Dow Chemical, LePetit and their associated firms; several of the affected firms were engaged in the marketing of breast prostheses in Europe, Australia and the Far East. As a result, dislocations in distribution took place but eventually, in several countries, the marketing activity became the exclusive mandate of Dow Chemical-related entities.
Foreign employees of Dow Chemical participated explicitly in decisions involving not only distribution but also engaged in the preparation of specialized product inserts, developed promotional strategies and literature and may also have directly influenced the design of some types of prostheses of interest to offshore clinicians. In addition, Dow Chemical staff and their associates had regulatory responsibility and were heavily involved in government relations regarding medical device regulations. They prepared pre-market documentation, master files and other regulatory approval documents in several countries. Some were further involved in activities on foreign patents pertinent to medical devices.
Independent contract distributors were also active abroad. They sometimes competed with the central marketing entities. For example, Canada, Italy and the Netherlands had smaller contract distributorships functioning concurrently with Dow Corning sales forces; some even distributed competing products concurrently. This situation remained until the eighties. In the late-seventies, the domestic marketing of Dow Corning medical products was segregated into a special unit and delegated formally to the Dow Corning Wright Corporation, a separately incorporated unit. A reorganization of foreign marketing also took place during the same period but large parts of this activity remained the exclusive province of Dow Chemical subsidiaries.
Dow Corning’s Knowledge of Medical Implant Risks:
Evidence suggests that Dow Corning staff were fluent with implant risks and were aware of major production problems within their product lines. Mandatory problem reporting programs introduced by the FDA in the late-eighties made public Product Complaints Analysis Activity by implant manufacturers. Complaint reports and their analysis by Dow Corning facilities reveal high levels of knowledge and skill in the assessment of implant failure. It also reveals a superior capacity for appraisal of production problems. It is most probable that Dow Corning laboratory personnel were highly sophisticated and were able to provide to management accurate analyses of product risks based on product returns, field complaints and close contact with the plastic surgery community and their clinical misadventures. Corporate documents indicate that thousands of failed specimens were studied by Dow Corning’s facility over the past twenty years and that Dow Corning personnel were fully aware, for many years, of product defects with major health risks. They also had unique laboratory capabilities and early opportunities that provided them with insight into the mechanisms of failure of implants.
With this information, Dow Corning could have resolved production problems and minimized user risks. Alternately, they would have been able to advise management regarding the liability exposure. Management would then have been forced to truncate this line of products before an uncontrollable liability situation developed. In this context, the attempted obfuscation of the FDA and the public with late and superficial studies hurriedly assembled to give credibility to the product is puzzling.
Following the FDA Moratorium, litigation surrounding Dow Corning products and their raw materials emerged into an international litigation problem of enormous magnitude. In 1993, an agreement was obtained with classes of plaintiffs claiming injuries from breast implants. On May 15, 1995, the Corporation filed a petition for Chapter II reorganization with the U.S. Bankruptcy Court for the Eastern District of Michigan. Dow Corning further sought injunctions against litigation for products they distributed. Further restraining orders were also sought against implant plaintiffs with ongoing trials against related defendant corporations. Reorganization under Chapter 11 is believed to have started in June 1995.
COLLECTIVE PRODUCT OVERVIEW:
The first commercial Dow Corning products included early versions of the “Cronin” breast implants as well as other items for plastic surgery of the breast. Early versions of gel-filled breast prostheses (Cronin Prototype, Cronin, Cronin Technique) were produced until the seventies.
In the early seventies, variations of round thin wall, stiff gel devices were marketed as the 500 Series. These were occasionally referred to as “Weiner design” or “Williams style” and were the precursors to the later 900s. The 900 Series were made in several variations between 1975 and 1984.
Custom-made variants and “tissue expanders were also sold under other Series codes. Surgeons names were sometime associated with such products. Basically the devices were all derivatives of the same early models with occasional changes in material composition and shell configurations.
Marketing practices surrounding the early Dow Corning “Cronin” implants as well as the 500 Series items varied. For example, distribution from about 1963 was delegated to large surgical product distributors which included: V. Mueller & Co., Chicago, Illinois; Pilling Co., Fort Washington, Pennsylvania; Storz Instrument Company, St. Louis, Missouri; Edward Weck and Company Inc., Long Island City, New York. Contract distributors were also active abroad. Canada, Italy and the Netherlands at different times had ‘contract’ distributorships. This situation remained until the eighties. Offshore production was initiated in Brazil circa 1983 thus further complicating the distribution.
It appears that Dow Corning lacked the capacity to market competitively in the medical products area. Predictably, nearly all of the firms engaged in the early marketing of Dow Corning mammary prostheses later became themselves manufacturers and marketed their own products in some cases concurrently with Dow Cornings. In effect, the activities of the sixties and seventies indicate a close relationship amongst Dow Corning, Baxter Travenol, Surgitek Medical Engineering Corporation, Heyer Schulte and American Hospital Supplies and their subsidiaries. The prime business for Dow Corning remained with industrial silicone products.
DOW CORNING ‘CRONIN’ SERIES MAMMARY IMPLANTS
The Dow Corning “Cronin” Series include both mammary prostheses derived from the very early “Cronin” design with a single large Dacron fixation backplate, later issues with four large sector-shaped patches and clustered small round patches as well as radically different products aiming to facilitate surgical “small-incision” insertion by increasing the deformability of the implants. Their key identification criteria include primarily the patch structure and the presence or absence of seams or obturating patches on the shell.
The prototype designs are credited to Thomas Cronin and Frank Gerow, two plastic surgeons at Baylor-Methodist Hospital in Houston, Texas. Thomas Cronin was then a staff surgeon. Frank Gerow was a Canadian-trained clinician who had emigrated to Texas in the early sixties. They had originally been looking for a “burn dressing” material.
The first batches of commercially mass-produced “Cronin” breast implants were released circa 1963 and included primitive, thick shelled, fabric-clad versions of silicone gel filled breast implants. Different versions of the “Cronin” were later produced.
In the early -seventies, major problems with the “Cronin” designs became apparent and the merit of fixation fabric “patches” was questioned. Some surgeons removed these patches before use. Later, prostheses were made without fixation patches and sold as investigational devices.. Still later variations of thin wall thin gel filled devices of similar oval or contour shape were also marketed, some had the coin size fixation patches. They included items in the 500 Series. with Dacron “spot” Dacron fixation. These superseded the “Cronins” but the name remained.
The last versions were discontinued sometime in 1974 and were replaced by variants of the “900” Series with fixation. Shell failures have been widely reported for the Cronins most from combined abrasion and stress concentration at folds.
Over the years, the Dow Corning “Cronin” Series implants differed significantly in gel and shell elastomer composition. The physical properties of later versions were also more erratic. Shell assembly workmanship and durability were at their worst prior to discontinuation in the early eighties. Correspondingly, adverse effects from the use of such devices vary qualitatively and quantitatively with type and production period. Major differences are generally noted between patients who received early products and those who received later prostheses.
The mode of failure is remarkably consistent with expectations. It is fatigue of the shell in areas near patches and subject to repeated pleating and cold working. This type of failure accounts for many adverse reactions and removals for the product. Health effects for patients who retained the prostheses for 10-20 years include metabolic alterations in the calcium utilization cycle, neurological disturbances, thyroid dysfunction and neoplastic diseases.
DOW CORNING 500 SERIES MAMMARY IMPLANTS
The Dow Corning “500” Series include both mammary prostheses derived from the early “Cronin” design as well as radically different products aiming to facilitate surgical “small-incision” insertion by increasing the deformability of the implant shells.
In the early sixties, the Dow Corning Medical Products Business developed prototypes of the “Cronin” breast implants based on the original “Cronin-Dow’ patent. Several different types were later produced in commercial quantities but all had the same ‘anatomic’ (contour) shapes and the characteristically thick shells, non-compliant gels and large parts of the posterior side covered with fixation fabric typical of earlier versions. In the early 1970s, major problems with the “Cronin” design emerged and the merit of fixation fabric “patches” was questioned. Some surgeons removed these patches before use. Later, prostheses were made without fixation patches and sold as investigational devices. Others surgeons were dissatisfied with the “Cronin” contour shape which required specific orientation.
The seventies brought other more compliant versions which were often based on different materials, shapes and construction methods. Some were of oblate spheroidal shapes (round styles). They were originally termed “Weiner Technique” implants but the nomenclature was overshadowed by the “Cronin” appellation. Competing manufacturers such as Heyer Schulte and Medical Engineering Corporation introduced similar items at about the same time using other terms such as “Sterling”, “Williams”, “Snyder”, “Georgiade” or “Wagner” Techniques. Still others wanted prosthetic objects with uncommitted shapes for fitting into irregular retromammary pockets. These requirements merged and “small, soft” devices evolved. Some of these attributes were incorporated into the early “500” Series. Still later variations of thin wall, fluid gel filled devices with round, oval or contour shape were also marketed, some had coin size open mesh Dacron™ patches for tissue fixation. Eventually, the “500” Series with Dacron “spot” fixation superseded the classical “Cronins”.
Many thin wall versions of the “500”s were produced between 1972 and 1975. Late variants included thin walls and unreinforced posterior surfaces. Some had different gel formulations. Visibly deviant production items were evidently released; they appear to be products issued from ad hoc investigations on manufacturing technology or material composition. The last versions of the “500” were discontinued sometime in 1974 and were replaced by the “900” ‘Transitional’ Series.
Shell failure is consistent with expectations. It is fatigue of the shell in areas near patches and subject to repeated pleating and cold working. This type of failure accounts for many adverse reactions and early removals for the product. The capsules are generally mineralized in for most users. Health effects and problem areas for patients who retained the prostheses for 10-20 years include metabolic alterations in the calcium utilization cycle, neurological disturbances, thyroid dysfunction and neoplastic diseases.
The Dow Corning “500” Series differed significantly in gel composition from the later variations of similar prostheses. Correspondingly, adverse effects from the use of such devices may be qualitatively and quantitatively different from what is encountered in patients who received earlier and later prostheses. The configuration and the position of the fixation patches on the contour style “500” is notoriously illogical (lower quadrant). It accounts largely for the early failure of those devices and explains why shells are generally found ruptured on the posterior side and in a unique pattern typical of very weak, thin wall objects subjected to prolonged and repeated stress cycles.
THE”900″ SERIES IMPLANTS
The Dow Corning 900 Series was the most widely used product of this kind in its time. Sales were world wide and are estimated to be in excess of 320,000 units. The implants were made with several variations of patches and included round styles, oval types and high profile as well as low profile products. Some had fixation features. Sub-series such as the P529 and “custom” variants also entered commerce sometimes as surplus material. Most 900s were comparatively thin shelled implants with a fluid-like gel. In some production runs, coherent gels were occasionally produced, possibly by accident. The shell materials were subject to fatigue damage and the manufacturing process was evidently plagued with serious problems as evidenced on the basis of corporate memoranda. The low profile oval devices were very prone to perforation.
The quality and the workmanship were variable attributes and the performance was erratic. Most early series were manufactured in Michigan by the Dow Corning Medical Products Business of Dow Corning. Later versions may have been manufactured in Sao Paulo, Brazil by a separate plant. It is not generally possible to identify the plant of origin from simple inspection; lot records must be consulted. The last versions of the 900 were discontinued sometime in 1982-84 and were replaced by the Silastic II Series.
DOW CORNING IMPLANTS WITH TISSUE FIXATION; SPECIAL PROBLEMS
Fixation style implants from Dow Corning were the most widely used products of their kind in the sixties and early seventies. Sales were worldwide and are estimated to have been in excess of 50,000 units. The implants were made in many patch configurations and included round styles, oval types and high profile as well as low profile products. However robust early oval styles such as the Cronins fell into disuse in the seventies. They were replaced by thin wall fragile variants, some containing fluid-like gels. The shell materials were subject to fatigue damage and the manufacturing process was evidently plagued with serious technical and administrative problems as evidenced by internal corporate memoranda. The products reached their nadir in the mid-seventies with the release of the Series 900 “fixation patch” implants.
All used knitted Lock-Stitch Dacron™ fabric ‘crepe’ mounted on silicone elastomer support plates with shallow embedment of the fabric along ‘tracks’ in the substrate. The quality and the workmanship were variable and the performance was erratic. Most were manufactured in Michigan by the Dow Corning Medical Products Business of Dow Corning. Later versions may have been manufactured in Sao Paulo, Brazil by a separate plant. It is not generally possible to identify the plant of origin from simple inspection; lot records must be consulted. Offshore distribution was generally delegated to local Dow or Dow Corning sales units. Freelance sales contractors were also used in some countries.
Rationale for Tissue Fixation Devices on the Late 900 Series Items
Many types of medical implants have incorporated means of immobilizing or suturing the items to tissue in order to facilitate the surgery. The stabilization of breast prostheses by embedding or suturing fixation appendages to fascia derives from early attempts at reconstructing extensively resected breasts. Displacement was frequently encountered during healing and over the early post-operative period and “fixation” appeared as a practical solution to the problem. The technique was later extended to cosmetic implantation by placing “open weave” texture fabric patches on the posterior side.
These patches were made in several sizes and configurations. All allowed ingrowth of tissue and immobilization of the device by causing fibrosis into fascia or integrating fabric into thick peripheral tissue capsules. Some manufacturers introduced small pieces of woven or velour Dacron fabric or “loops” which allowed fibrosis or suturing of the device against the chest wall. The stiff fabric appendages frequently caused early failure of the shell by locally stressing the material. Later alternatives included multiply perforated plastic film “patches”.
The fixation option appeared first on saline-filled products but was evidently abandoned because of early deflation. Evidently the system was not tested. Explanted devices of this type clearly demonstrate the risk and the irrationality of the approach, even to an unsophisticated observer. Tissue grows into this pocket and achieves immobilization. However, this space, being a blind pocket, does not provide for blood irrigation and extracellular fluid cleansing. As a result, tissue necrosis sets in and eventually mineralization occurs to form dense, often continuous, calcific plaques and concretions. These often occupy the complete interior space of the capsule. Large crystals occasionally penetrate the prosthesis wall.
Other problems such as infection, became evident later. The pocket was infection-prone, possibly because it was a stagnant area. Antibiotic irrigation of the area was, for practical purposes, impossible. Infections, when they occurred, were uncontrollable. Such phenomena had already been noted in vascular surgery where blood vessel repair devices are used. For example, arterial prostheses and endocardial repair fabrics were well known to entrain similar infections. Over the long term, it became more widely known that fixation systems served no purpose other than to enhance the risks. They were abandoned in the 1980s.
Retrospectively, the fixation systems are credited with many episodes of infective complications and late calcification. Very few patients who retained the devices for more than ten years avoided these problems. Systemic and autoimmune abnormalities are also widely encountered amongst these individuals. The most visible problems are encountered on removal; such implants complicate the surgery. Dissection of the capsule is rendered more difficult by hard debris which blunts instruments and impedes Bovie action. Mineralized concretions occasionally take the form of crumbly plaster-like nodules of more than 5 mm in thickness. Comparable problems are encountered in other variations of fixation systems which include fabric reinforced silicone sheets intended for suturing to fascia and other rarely used features such as discrete sewing tabs for suturing. All induce fibrosis and fix the devices to tissue. Such items are occasionally encountered in reconstructive prostheses.
Early patients fitted with such devices include some of the most severely injured. The visible part of their injury is mechanical and is the result of local anatomic remodeling and the surgical difficulties that are encountered in removing the tissue-embedded device. However, systemic damages may be the result of protracted chronic infections which remain undiagnosed or untreated for many years. Other problems may be a result of early shell failure and oil leakage from these fixation systems, one of the more frequent consequences of this design feature. Problems may also reflect early and chronic tissue-protein-capsule-oil adjuvant interactions leading to capsular tissue degeneration and denaturation.
The severe calcification frequently noted in these patients supports the belief that tissue denaturing processes occur in these stagnant”fixation” areas and that such devices induce major metabolic disturbances by incubating synthetic and natural substances to produce pharmacologically active entities.
Summary of Problems with Fabric Fixation Systems:
– The devices are obsolete supra muscular implants with fabric fixation patches causing chronic tissue reaction that frequently culminate in severe local mineralization and necrosis,
– Significant level of silicone oil and other prosthetic debris contamination enmeshed in the patch fabric; secondary growth of large, sharp, glass-like calcific entities within the capsular space in the patch zone,
– Dissemination of biologically active prosthetic degradation products from the implantation site to distal points with possible secondary mineralization,
– Possible immunologic phenomena associated with incubation of endogenous
material within the stagnant, fabric laced, chemically reactive environment of the prosthetic pocket at the patch zone,
– Hemosiderin and related solid deposits from repeated microhemorrhages in the periprosthetic tissue as a result of constant excoriation and penetration of tissues by sharp calcific plaques and tension from the adhering Dacron fabric,
– Difficult explantation with elevated risks of hemorrhage, infection and post explantation deformity.
– Laborious dissection of extensively fibrosed and mineralized tissues with rapid attrition of the cutting edge on sharp instruments,
– Possible detachment and retrieval of firmly tissue embedded, calcified fabric patches from the posterior face of both prostheses during capsulectomy,
– Restricted intraoperative visibility of the retroprosthetic space during separation of the posterior surface at the patches ( a fibreoptics viewer can mitigate the problem)
– Weak, friable and probably partly torn shells on the posterior face near the fixation patches and at the “envelope seam” in the upper quadrant,
– Contraindications for electrodissection and / or electrocoagulation (Bovie) in the vicinity of calcified areas (it is ineffective) and in grossly oil contaminated tissues (it produces silica with possible adverse tissue reactions and systemic immunochemical impact).
– Possible presence and control of colonies of micro-organisms encapsulated with the prostheses or in separate pockets within the surgical area,
– Risk of injury to surgeon when attempting to explore calcified tissues, especially, within the implant pocket (large calcific plaques can easily cut surgical gloves and skin).
DOW CORNING SALINE INFLATABLE IMPLANTS – THE VARIFIL™ 200 SERIES
Following the early commercial success of the Arion-Simaplast saline-filled prostheses imported from France, Dow Corning became involved with saline-filled implants. Their early versions were made in 1970 and had Dacron™ tricot fixation patches on the posterior side. Deflation and contracture problems were encountered almost immediately, primarily because of the “Cronin” style fixation patches which caused stress concentrations at the patches.
Later versions became known as the Dow Corning Varifil™ or Series 200 Saline Inflatable Mammary Prostheses. These items had no fixation patches but deflations continued to plague the product line. Shell failure through pleat-fold fatigue and rapid contracture accounted for many early complaints; faulty valves and infections added new problems later. Assembly line staff evidently encountered production difficulties when attempts were made to scale up production; rejects increased because of major shell defects and debonding of valve parts.
In response, critical portions of the assembly were delegated to outside “contractors”. By 1977, parts of the 200 Series, as well as components of a structurally similar combination gel-saline (Series 300) implant were fabricated extramurally. Curiously, a competitor was chosen for the work. The items were fabricated by Cox Uphoff Corporation of Santa Barbara, California, then a new and small offspring corporation founded by former employees of Heyer Schulte who had previously worked for Dow Corning.
This Series of Dow Corning/Cox Uphoff variants are easily identified; they incorporate a unique filling valve configuration which continued to be used on Cox Uphoff implants into the early eighties and is characterized by a discoid termination on the inner end of the filling valve stem. Later variations deleted this part and made the stem differently from die-cut sheet parts.
The product line fell into disuse in the late seventies following reports of endemic replacement of failed units by U.S. surgeons. The design was later discontinued in a climate of negative publications, internal corporate recriminations, FDA enquiries, production problems, embarrassment and litigation which eventually involved all saline inflatable implants from all manufacturers.
Production of the Dow Corning 200 Series was abandoned and distribution ceased in the U.S. circa 1980. Some surplus stock may have been liquidated outside of the U.S. The ‘200s’ are very rarely encountered; most were removed in the late-seventies and eighties.
In its time, the Varifil™ was a case example of faulty production practices, poor material selection, inadequate quality assurance and self-destructive marketing strategies. It provided a foretaste of product litigation which was yet to come. User dissatisfaction broke out publicly later when a number of Canadian and U.S. plastic surgeons filed claims against Dow Corning for lost wages, damage to professional reputation and mental distress arising from patient complaints. Three prominent Montreal surgeons eventually recovered significant sums of money surrounding serial failures with large numbers of units. Litigation surrounding the inflatable then spread to other manufacturers.
The Varifil inflatables of the late-seventies became notorious for poor field service and the manufacturer’s reputation suffered accordingly. Pre-litigation expenses consumed a significant part of sales income and later outstripped the total gross income of the product line.
Paradoxically, the concepts and the production equipment used in the 200 were transposed to the combination gel-saline termed the ‘300 Series’. This device was in effect a conventional 900 Series, gel-filled implant core inserted in a 200 Series Varifil™.
THE “300” SERIES GEL-SALINE OR DOUBLE LUMEN IMPLANTS
The Dow Corning “300” Series gel-saline (double-lumen) implants were distributed world wide from about 1978 but were not widely used. Unlike some competing designs, they had a “free floating” inner core made from a standard gel-filled implant which was enclosed loosely by the outer envelope. The outer part was originally a stock saline implant. Such composite products were manufactured from the late seventies to the mid eighties.
Early lots of “300” Series were partly manufactured by the Cox Uphoff Corporation, competitor, through a series of sub-contracts. The details of the transaction and the number of units manufactured are not publicly known to this day. There is minimal information on that era of Dow Corning in the documentation filed under MDL 926. At any rate, it is surprising that a corporation claiming leadership in medical silicone products such as Dow Corning would seek association with Cox Uphoff at that time. These Dow Corning/Cox Uphoff “300” variants are easily identified; they incorporate a unique filling valve configuration which continued to be used on Cox Uphoff implants into the early-eighties.
Other items of the Series were made with different types of valve/ports. Shell patches also varied. The “300s” came in round styles but later versions also included oval and/or teardrop shaped products. The gel core remained a common “900” Series implant until the mid-eighties. Corporate records indicate that quality assurance standards were reduced or suppressed for the “900s” that would become the core part of the “300” items. The rationale appeared to be based on the belief that the outer shell would “contain” a rupture of the inner shell. For some batches, rejected or defect-bearing “900s” were used on the premise that the outer (saline) shell would make the defects less hazardous and less obvious.
Design specifications required comparatively thick outer shells. Consequently, the items pleated and puckered easily; palpable projection resulted. Generally, the gels used in the core prosthesis were fluid and mobile; the rate of effusion of the oil/gel was generally elevated and easily permeated both shells, rendering the outer shell “greasy”. These peculiarities led to numerous complaints about the product in the early and mid eighties.
Manufacturing processes were evidently not consistent. Cox-Uphoff facilities were used only for the early production items. Most of the post-1980 implants of that type appear to have been made at the Hemlock, Michigan production facility.
In later series, the gel permeated and damaged the inner shell. Many such shells failed and the extravasated gel eventually degraded to an oily consistency. It caused the outer envelope to swell and later fail, thus releasing a contaminated gel-oil-water emulsion into the user either as a large bolus or as gradual leakage. Many “300s” suffered shell deterioration over a short time.
The last versions of the “300” included Silastic II “barrier” variants. These appeared in the 1987-91 period and used fluorosilicone-lined shells based on “gel barrier” technology patented by the 3m/McGhan Corporation,a decade earlier but the overall performance of the product did not improve.
Gross chemical and microbiological contamination of the outer lumen, early inner or outer shell failures and severe gel permeation have been widely reported for this sub-group of product. They constitute the primary causes of morbidity for the product.
The mode of failure is often different from other similar item designs. It is partly related to plasticization of the outer shell material by a reactive oils followed by distension and failure of the envelope. Classic pleat failure and fatigue of the shell in areas subject to repeated pleating, sharp creasing and abrasion also take place.
GEL-FILED BARRIER TYPE SILASTIC II™; HISTORY AND PROBLEM AREAS
The Silastic II prostheses were developed under accelerated conditions in the early 80s. The effort was in response to widespread technical problems, adverse reactions and product complaints affecting the antecedent earlier “900” product. In 1984, production of the “900” was terminated and purchasers were advised that “the equivalent” Silastic II would be supplied instead.
Early Silastic IIs were significantly different from the later versions. The earlier designs used molds similar to the “900”s but made use of a multi-layer (dipped) overcoating process. This amounted to making the shell by using several types of different polymers in different dipping baths in order to achieve the laminated barrier effect. It was reasoned that the original silicone wall formulation was not an adequate barrier to the permeation of oil from the interior. A different type of material was therefore chosen to form a discrete laminated layer that would resist oil effusion (gel bleed). Unfortunately, this “barrier material” did not have good mechanical properties and failed to produce mechanically-sound shells. A modified silicone was therefore chosen as the main body of the shell and the role of the barrier layer was limited to controlling oil losses.
Later versions of the product used a process called “rotocoating” where a solution of fluorosilicone precursors in solvent was injected into finished shells and allowed to form a film on the inside of the device. Still later variations were produced with different manufacturing protocols and different patch styles. Most of the specimens that are recovered from the very early investigational series were a marginal improvement over the notoriously poor “900”s. The later versions, however, were subject to gross variations in production characteristics and often had gross mechanical defects in the shell or in the patch.
Predictably, the items are of erratic performance. Those that fail early suffer a unique type of outer shell/inner barrier deterioration which is not encountered in other systems. Delamination of the layers also takes place, in particular in the high stress areas. When the barrier effect is lost, the main shell layer softens and swells to produce a distended almost flat prosthesis with unusual surface phenomena such as stickiness, porosity, discoloration and uplifting of the outer coat. The interior barrier layer is often visibly damaged and separated from the outer shell and particles of it are dispersed in the gel.
Whereas the devices were promoted on the basis of “low gel bleed”, it appears that this benefit is of short duration, possibly lasting only for 1-2 years. After that, the rate of effusion of oil/gel accelerates rapidly. It may eventually surpass that noted in conventional types.
Additional observations on the Silastic II include unusual reactions with tissue, self-adhesion of the shell (to itself) within pleats/folds leading to pockets of captive necrotic tissue, biological fluids and debris. Shell failure of the same type as encountered in other conventional wall prostheses does not take place initially in very many Silastic IIs. From initial appearances and on considering the mechanical properties when new, the products seem more tenacious and hardy than earlier versions. However, this is illusory. After a few years, the shells are visibly impaired and questions of shell safety and gel containment after 5-7 years become areas of concern. Anomalies in gel characteristics are also widespread.
Recovered products include items with very highly cross-linked gels with strong memory and well as gels which are little more than mobile fluids. Possible explanations may have to do with polymerization antagonists or incorrectly formulated gel precursors which incorporate inadequately reactive mixtures to produce the appropriate gel. Other possibilities include reactants that are used for the fluoropolymer coating that adversely affect the polymerization of the gel or else that chemically degrade the gel or cause changes in the shell properties. Outright contamination or failure to standardize vulcanization conditions may account for other deviant batches. Devices encountered with shell failure often show abnormal shell color (yellow) as well as very fluid gels.
When shell failure or perforation is encountered, it correlates with areas of unusual surface texture. These generally are zones with layer delamination or “crazing” of the interior barrier layer. Such a process amounts to the loss of continuity in the coating. Pleats with perforations typical of earlier types of failures are rare on the Silastic II; these devices appear to fail through loss of shell tenacity in areas where chemical differences are present or where flex or movement have weakened the structure.
Possible explanations for the problem may be found in the manufacturing protocol. Audits performed retrospectively on post-1985 batches revealed instances of incorrect curing and subsequent alteration of records. Inadequately-cured devices were evidently released. It is surmised that it is from these batches that the earlier failures will occur. Information regarding these batches may be obtainable from corporation records that were audited by outside investigators and until now have remained as protected corporate documents.
The Dow Corning Silastic II was based on a patent owned by 3M/McGhan. This is even more surprising considering that Dow Corning had developed a similar process in 1979-81. The Silastic II may entail production conditions which are mutually incompatible. Thus, the product may have been doomed to failure from the start. The toxicological implications of the chemical failure of the system are also inadequately researched. The rationale for releasing the technology offered by Dow Corning to the FDA is also unconvincing. There were claims of “substantial equivalence” to earlier products. This is an unsupportable proposition as there were major changes introduced in the chemistry and manufacturing process.
The Silastic II manufactured during that period by Dow Corning Wright, does not appear more durable than the earlier 900s. Worse yet, the items produced during that period leaked as much oil as ever and their surface degraded rapidly. Their life expectancy appears limited to 5-8 years in vivo and individual items from certain batches may have potential for tissue injuries of a kind that is different and which may surpass the risk of earlier series.
LATE BARRIER PRODUCTS AND MSI TEXTURED IMPLANTS
The late Dow Corning prosthetic systems differed in design and composition from the earlier series. The Silastic II and the later MSI variants were based on laminated shell technology developed under accelerated conditions in the early-80s.
The MSI appeared in the late-1980s and was offered as a solution for capsular contracture. It involved the manufacturing of the outer shell on a laser-machined mold containing many fine craters created by the laser process. This type of mold could then create shells with columnar elements as an integral part of the outer surface. Such products were otherwise similar to the Silastic II but had additional problems of contamination (from difficulties in cleaning the mold recesses) and spallation of the columnar elements (from abrasion of the surface at pleats and against calcified tissue). The product had a brief commercial life; it was withdrawn at the same time as the other products based on gel technology in 1991.
When shell failure or perforation is encountered, it tends to correlate with areas of unusual surface texture. These generally are zones with layer delamination or “crazing” of the interior barrier layer. Such a process amounts to the loss of continuity in the coating. Pleats with perforations typical of earlier types of failures are rare on the Silastic II; these devices appear to fail through loss of shell tenacity in areas where chemical differences are present or where flex or movement have weakened the structure. Possible explanations for the problem may be found in the manufacturing protocol. Audits performed retrospectively on post-85 batches revealed instances of incorrect curing and subsequent alteration of records. Inadequately-cured devices were evidently released. It is surmised that it is from these batches that the earlier failures will occur. Information regarding these batches may be obtainable from corporation records that were audited by outside investigators and until now have remained as protected corporate documents.
The Silastic II and its later textured variants, the MSIs, as manufactured during that period by Dow Corning, do not appear more durable than the “900”s. Items of this kind leak as much oil as ever. Their expected lifecycle appears limited to 5-8 years in vivo and individual items from certain deviant batches may have toxic potential which surpass that of earlier series.
The MSI may embody additional risks. The molds with their deep recesses are virtually impossible to clean. As a result, many of the textured devices were produced with incorporated (casting inclusions) debris into the distal part of the spicular elements. The possibility of viable micro-organisms as well as chemical impurities being part of such shells is, therefore, very elevated and reactivity of such contaminated elastomer is expected. In addition, the degradation of the shell material would lead not only to softening of the shells (it takes place for the Silastic II), but the spicular elements will detach from the surface and create a new and different type of foreign body reaction. The recovery of debris from such prostheses will prove more difficult. However, these devices were in use only in the last years of the pre-moratorium era. Therefore, they have had only a brief dwell time and gross deterioration of the MSIs will not be a clinical factor until about 1995-98.
DOW CORNING WRIGHT TISSUE EXPANDERS – HISTORY AND PROBLEM AREAS
Dow Corning fabricated various styles of tissue expanders from about 1978. Some appeared in catalogs, others were listed as “custom made” designs. Some are associated with prominent plastic surgeons. Most embodied conventional shell-making technology similar to what was then used by Dow Corning for manufacturing saline inflatable shells. Expanders were generally more complex than the saline prostheses counterparts. Some had additional parts made of fabric reinforced silicone sheeting. Others had fixation “loops” or anchor points. All had separate or integrated filling ports designed to facilitate the filling of the shells with the saline solution.
There appears to have been little effort in developing these designs into safe and practical medical devices for reconstruction. Instead, a wide diversity of singular “inflatable” implants were produced through the years. Many used implant parts sold for other purposes and were little more than ungainly assemblies of liquid-filled compartments which could be inflated jointly or separately to approximate the sought shape.
In the late-eighties, stacked or multiple compartment “assembled” expanders were added to the line. These consisted of existing types of devices bonded together with silicone adhesive. They compounded the problems of the component implants. Sales remained at a low level until the final discontinuation of the products.
Textured surfaces appeared in late versions of tissue expanders. These were called “MSI” Series and had surfaces with densely packed columnar elements which were claimed to reduce capsular contracture. The MSI type surfaces were created by casting the outer shell on a laser-machined mold with fine craters. These “craters” were obtained by laser ablative action. The process introduced “texture” as an integral part of the outer surface. The MSI expanders and salines had a brief commercial life and were evidently made in relatively small numbers.
IDENTIFICATION METHODS AND CRITERIA
D.C. Cronin Technique, Early Issue:
The devices are identified as Dow Corning ” Cronin” mammary implants of early production (circa 1964-67). These were also known as “Cronin Technique” implants. These products differ substantially from later “Cronins” produced in the seventies. The two provided specimens are early production models. Criteria of identification include a thick shell with a prominent equatorial seam along the margin (equator), four trilobal (sector shaped) Dacron™ muslin tissue ingrowth fixation patches, a thick ‘beaded’ shell seam at the meeting point between the anterior and posterior side, an oval shell shape and shell material characteristics consistent with Dow Corning prostheses. Catalogue numbers may not have existed for this series. The items were termed “Small, Medium, Extra Fill, Large”, etc. Items of this kind were later sold under private namebrands by large medical supply distributors. A typical example would be a 365 cc “Cronin” sold under Cat. No. N-5894 by Storz.. The MDL 926 “Unique Identifier” published for this class of implant include the knitted crepe Dacron fabric fixation patches consisting of a composite of stitched fabric bonded selectively along ‘parallel tracks’ onto a silicone elastomer substrate, each patch being paired with a mirror image and having a sector shape with the lowermost patches being smaller than the upper ones. Another distinctive feature is a palpable ‘seam’ in the elastomer at the margin between the anterior and the posterior side.
D.C. Cronin Technique Late Issue:
The implants are variants of Dow Corning “Cronin Technique” contour, fixation type devices. They are late sixties items belonging to the 500 Series. Such items have the following identification criteria: five discoid shaped fixation patches made from Dacron™ crepe with the two lowermost patches bridged together by a fabric isthmus. The three main discoid fixation patches measure about 25 mm and occupy the upper quadrant. The items have a prominent contour shape, a thick shell without seam at the margin and a cohesive gel with a comparatively marked shape memory. The MDL 926 “Unique Identifier” is the fabric knitted crepe fixation patches arranged in a circle on the posterior side with the lowermost patches being bridged together in a dumbbell shape.
D.C. Varifil, Series 200, Saline Inflatable:
These devices are saline inflatable implants sold from about 1972 to about 1980 and were made in several variations. Such items are now rarely recovered as most failed early and were explanted following deflation. There are sub-series which used Cox Uphoff valve components and which may have been made in part at the Cox Uphoff facility in Santa Barbara, California under a sub-contract. They have the following attributes: a transparent shell which resembles the early issue Dow Corning 900 Series gel-filled, low profile implant, shell markings compatible with Dow Corning shell mold marking practices of the mid and-late-seventies and a valve/patch structure typical of the subcontracted Dow Corning/Cox Uphoff leaf valves with the round, internal disk. Characteristic attributes of this series include: a decentered valve/patch on the posterior side, a grease leaf valve with a stem of 35 mm and a width of 8 mm fitted with a 9-10 mm elastomer disk on the internal opening, an underlay style patch of 35 mm placed at a 26 mm shell aperture. The principal distinction between the early and the later issues is with respect to the presence of a separate silicone elastomer disk placed on the internal exit of the valve. The MDL 926 “Unique Identifier” for this type of device is the labelled shell and the unique valve configuration with the discoid internal termination.
Dow Corning Series 300, Double Lumen, Late Issue:
The are Dow Corning double lumen implants of the late seventies. Most late versions used Dow Corning components. Earlier versions used valve and outer shell parts which may have been manufactured by a sub-contractor (Cox Uphoff, Santa Barbara, CA). Typical specimens have an internal and an external shell which are separate (unconnected) and distinct from one another, an internal gel core consisting of a standard late issue 900 Series low profile implant, shell markings on the inner shell which are compatible with Dow Corning shell mold marking practices of the late-seventies and eighties and occasional shell markings on the outside shells. These devices differ from earlier issues with respect to the valve design. The criteria of identification include a round shell with a low profile and an assembled leaf valve combined with a grease seal which is made of die-cut parts and is an integral part of the outer shell patch. The principal distinction between the early and the late issues is the presence of the aforementioned 1.2 cm silicone disk placed on the internal exit of the valve. The MDL 926 “Unique Identifier” for this type of device is the labelled shell patch on the inner shell bearing the trademark “Dow Corning”.
Dow Corning 500 Series, Round, High Profile, Weiner Style:
The implants are different variants of the Dow Corning 500 Series mammary prostheses produced in the 1970-72 period. Termed “Weiner” style prostheses, they are round, high profile items with very thin shells. Criteria of identification include a decentered shell patch consisting of a composite assembly with an internal film of elastomer of about 27 mm and a central fabric knit reinforcement disk of approximately 1.2 cm for the gel fill hole at the center of the patch. The gel fill hole of about 3 mm is habitually not sealed. It is left open allowing effusion of oil and ingrowth of tissue. The distinctive feature of the patch is the Lock-Stitch Dacron™ knitted fabric (hexagonal pattern). Shell markings are consistent with Dow Corning’s mold identification practices of the early seventies. The MDL 926 “Unique Identifier” for this class of product is the numeric shell marking. The Dacron Lock-Stitch fabric disk of 1.2 cm embedded in the complex patch assembly as described above is another distinctive feature.
D. C. 500 Series Contour, Non-Fixation, Early Issue:
From about 1970-75 and are derivatives of the classical “Cronin” prostheses of the sixties but do not have the usual fixation patches. The criteria of identification include one unique coin-size shell patch located on the posterior side adjacent to an horizontal slit. The area incorporating the patch and the slit is further reinforced with an ovoid oblong patch with embedded Dacron crepe knitted fabric. Additional criteria of identification include shell markings usually consisting of a single alphanumeric digit. The unique composite shell obturating patch is the distinctive feature of these devices. Additional criteria include a characteristically coherent gel with marked-shape memory. These products were sold by several large distributors of medical supplies; they were often listed and catalogued differently depending on the supplier.
Transitional 500/900 Series:
The products include round, ovoid, high and low profile type. The items are not conventional 500 Series items but are devices issued late during the production history, incorporating most features of the later 900 Series. Some were sold under 900 Series labels. The criteria of identification include the same overall presentation as conventional 900 Series (described below) with a moderately thick, cohesive gel and a marked shaped memory, a round, low profile shape and a decentered patch. Unlike the normal 500 Series which shows only a small central gel fill hole fabric reinforcement of approximately 1-1.1 cm, these transitional variants have the large Dacron Lock-Stitch fabric reinforcement on the whole patch area but the gel fill hole is left open similarly to the conventional 500s. Some show a very thin layer of adhesive which normally reopens during the dwell time of the implant. Both devices bear unique criteria for Dow Corning products of the mid-seventies (early issue) which consist of a 32-33 mm Dacron knit reinforced patch placed as an underlay on a 23-24 aperture with a supplemental central reinforcement of 1.1 cm and the gel fill hole on the center of this reinforcement. Other criteria of identification include a single alphabetical shell marking which is symbolic for the nominal size of the device. The MDL 926 “Unique Identifier” is based on shell markings.
D. C. 900 Series, Two Patch Fixation, Contour:
These are contour style, high profile types with two patch Dacron fixation made circa 1975-83. Criteria include a prominent ovoid or contour shape with a nearly flat posterior surface, a main shell patch which is doubly reinforced with Lock-Stitch knitted Dacron fabric embedded in silicone elastomer. This feature differentiates early versions from later items of the same kind which did not have fabric reinforcement in the main shell obturating patch. Unlike the non-fixation items, there is no orientation bar molded in the shell adjacent to the patch. Two laminated discoid structures consisting of an elastomer layer with loosely bonded Dacron muslin are affixed to the posterior side; one is superposed directly on the main shell patch. These structures are termed tissue fixation patches. Shell markings consisting of a letter prefix and a supplemental three digit numerical suffix is typical of Dow Corning items of this era. This format of shell numbering is consistent with Dow Corning mold marking practices initiated in the mid- seventies. Mold marking practices of Dow Corning associated the prefix with specific styles and sizes. Numerical prefixes denoted high profile implants; alphabetical prefixes denoted low profile devices. The first character identified the size of the shell. However, Dow Corning shell marking practices of the time were not always consistent with gel filling. The MDL 926 “Unique Identifier” for this series of devices is based on the shell markings. The compound main shell obturating patch consisting of laminated fabric with elastomer and with a supplemental 10 mm underlay also Dacron-reinforced for the gel fill hole is also distinctive.
D.C. 900 Series Non-Fixation, Late Issue:
These are later versions of the thin shell round prostheses of the seventies manufactured circa 1978-83. They were made in round and ovoid styles in high and low profile versions.The criteria of identification include a trademarked shell patch of approximately 29 mm applied to the shell as an underlay, off-center with respect to the posterior side of the device. This patch incorporates the gel fill hole at the lap or a prominent zone on the central part of the patch. The gel fill perforation is further sealed with a spot of adhesive. Shell inscriptions consistent with Dow Corning’s late-seventies mold marking practices (one large alphanumeric digit followed by three smaller additional alphanumeric digits) are also present. The MDL 926 Unique Identifiers are the shell markings and the trademark “Dow Corning” on the shell patch.
D.C. 900 Series, Round, with Three or More Dacron Patches for Fixation,:
The implants are round, high or low profile versions with fixation patches. Such products were manufactured from the mid to the late-seventies circa 1975-79. The criteria of identification include a fabric reinforced main shell patch of approximately 29 mm applied as an underlay and off-centered with respect to the posterior side of the device. This patch incorporates the gel fill hole at its center and the perforated area is reinforced by an additional disk of knitted Dacron™ fabric reinforced sheeting. Shell inscriptions consistent with mid-seventies mold marking practices are also notable. The MDL 926 Unique Identifier for this series of devices are the shell markings and the compound fixation patches consisting of laminated fabric with elastomer and with a supplemental 10 mm underlay also Dacron-reinforced at the gel fill hole.
D. C. Wright Silastic II:
These are early versions of Dow Corning Wright Silastic II barrier mammary prostheses of low or high profile styles produced in the 1983-88 period. Criteria of identification can include a trademark on the shell patch. Some had featureless patches similar to the 900 Series. Shell markings were of a style consistent with Dow Corning mold identification practices of the early and mid-eighties. Patch markings usually included “Dow Corning” in linear lettering as opposed to the circular lettering used on later (post-1988) series. These markings were deemed MDL 926 “Unique Identifiers” jointly with the trademark “Silastic II” on the patch. Devices with featureless patches were generally custom or investigational products for limited distribution.
Dow Corning Silastic II, Late Issue:
The implants were significantly different from the early Silastic II with respect to patch and shell marking practices. Some batches also appear to be of different composition. Similarly to the earlier production items, the late Silastic IIs were of the ‘barrier’ type and incorporated fluorosilicone coating technology. Criteria of identification include a unique format for the trademark on the shell patch and shell markings of a style consistent with Dow Corning mold identification practices of the early-nineties. The circular lettering is the most characteristic feature of the late series. The MDL 926 “Unique Identifier” for this type of prosthesis is the same as the earlier versions.
Dow Corning Wright MSI Series:
Such implants are textured variants of the Silastic II produced in the 1990-91 period incorporating an added textured exterior surface consisting of micro-columnar elements. Various types were made including bilumens. Criteria of identification include a trademark on the shell patch and very small ‘laser’ style shell markings at the boundary of the patch with a complex mold code incorporating a letter and 4 or 5 numerical characters. The patch style is consistent with late Dow Corning manufacturing practices of the late-eighties and early-nineties with circular lettering as opposed to the linear lettering typical of earlier series. The unusual shell surface properties, the patch trademark and the shell markings provide the basis for identification.
With thanks to http://www.angelfire.com/tx5/calamity/history.html
In 1954: DOW Corning/Chemical finds that silica in silicone implants has a high order of toxicity
In 1954/55: DOW Chemical was informed…by scientist H.C. Spencer in 1954 that silicone causes health problems, and by Dow Chemical scientist, V.K. Rowe in 1955 that silicone spreads throughout the body, and causes organ damage!!!
In 1960: Silicone injections were classified as a criminal offence
In 1968: A scret study conducted by DOW revealed that dogs were implanted with silicone gel filled bags and the silicone leaked and dispersed through the system.
In 1968: “Cockroaches went into the silicone fluid only…and…never got more than a few inches from the dish before dying…” (Texaco and Shell studies obtained from Dow Corning).
In 1975: “I don’t know who is responsible for the decision (to put faulty implants on the market) but it has to rank right up there with the Pinto gas tank!!!” (Bob Schnabel. Dow Salesman, in letter to his boss)
In 1975: Plastic surgeons complained to DOW Corning that the implants were oily and seemed to be leaking. Salesmen were instructed to wash and ry the implants before showing them to doctors (Buyers)
In 1975: DOW Corning’s company training video for plastic surgeons is edited – to delete – references to implant ruptures.
In 1976: Thomas Talcott, senior DOW Corning materials engineer leaves DOW Corning in a dispute over the safety of silicone.
In 1976: DOW Corning study reveals that the lining of silicone implants, loses strength when sitting on the shelf.
In 1976: Art Rathjen a DOW Corning technical services specialist complained about the lack of any scientific evidence for safety of silicone.
In 1978: DOW Corning misrepresents in a patient brochure that laboratory studies prove that implants last a lifetime.
In 1978: William Bolet (DOW Corning’s Chief Biomaterials Safety) said that it is highly probable that a woman’s onset of lupus is connected to silicone implants.
In 1978: DOW Corning started receiving complaints from salespeople and surgeons, that implants can spontaneously rupture.
In 1985: William Boley and other DOW scientists conclude that the preponderence of available data suggests that silicone can produce immune mediated diseases.
In 1990: “At hearings in December 1990, Dow Corning misled the House Committee on Government Operations by testifying that silicone posed no safety problems or health risks. In addition, Dow Corning also refused to provide key documents requested by the committee” Rep. James Traficant
In 1992: The FDA limits future sales of silicone breast implants!
In 1993: “…There were no tests for implant materials…All we could do was put it in and look and see what happens. There were no standards.There was no protocols..There was nothing.”..(Silas Braley desposition, former director,Dow Corning’s Center for Aid to Medical Research.1993)
In 1993: DOW Corning acknowledges that silicone may not be inert.
In 1993: Chief medical officer for DOW Corning said “It clearly raises my concern that silicone gel might cause immune-system diseases.”
In 1994: Plastic surgeons file lawsuits against DOW Corning for damaging their reputation and for misrepresenting the quality of the implants.
In 1994: If you have (or had) a ruptured silicone breast implant, you will be denied Health Insurance Coverage.
FYI: The FDA has stated the rupture rate is over 70%
Silicone gel breast implants are the most commonly used breast prosthesis worldwide. They have been available since 1963, and have evolved dramatically over the last 40 years. Understanding the history of the development of these devices is important when you are considering any type of breast implant. The age, and the generation or type of breast implant is important, because more complications are associated with earlier generation devices. The organization of silicone implants into generations aids in understanding the evolution of these devices and the improvements in complication rates over time.
First Generation breast Implants
The first generation of silicone gel implants corresponds to devices developed in the 1960′s. These include the original silicone implant manufactured by Dow Corning from 1964 to 1968. These earliest devices were characterized by Dacron patches, which were placed on the posterior wall. They were produced until the early 1970′s and the most common complications were capsular contracture (hardening and distortion of the breast implant caused by scar tissue) and rupture.
Explanted 1st Generation Implant-1969
Second Generation Breast Implants
The second generation of implants was also produced by Dow Corning, from about 1972 until 1986. These devices were modified with a thinner shell and less viscous or thinner, more liquid gel. In addition, the patches were removed. These changes did not, however, reduce capsular contracture rates.
2nd Generation Device 1973