Corporate History:

Surgitek is a trade name associated the Medical Engineering Corporation (MEC) of Racine, Wisconsin. MEC was founded circa 1968. Originally known as Surgitool, it was initially connected to Travenol Laboratories Artificial Organ Division. Travenol is a precursor to Baxter Travenol. This organization had been involved in the manufacturing of implants in the early-seventies through Surgitool This firm produced the Beall-Surgitool and the Cromie-McGovern cardiac valve prostheses.

These valves had been developed at Baylor-Methodist Hospital of Houston at about the same time as the Cronin Breast Prostheses. The valves created a major health care crisis circa 1969 when they were found to disintegrate and embolize after a few years of use. The associated morbidity and mortality continued throughout most the seventies and ultimately, surviving salvageable patients who constituted a significant part of the original ten thousand valve users had to undergo replacement of their faulty cardiac valves. Surprisingly, the same valves reappeared in new forms as part of the Surgitek product line of MEC in the seventies.

MEC reincorporated under several names and evidently conducted pre-commercial development of medical devices under the name of Lakeside Engineering in the late sixties and early seventies. In 1972, the firm formally entered the rapidly developing cosmetic surgery market. Some of its first products included mammary prostheses developed in Canada. Its first products in this area included largely analogs of devices made by other U.S. manufacturers of medical implants. It released primitive silicone gel-filled mammary implants such as the Papillon-Perras silicone-polycarbonate "bag" implants and the Snyder contoured implants. The line was later broadened to include variations of devices which completed their product line and made it very similar to those sold by Dow Corning, McGhan Medical and Heyer Schulte Corporation.

Late in 1982, MEC was sold and became a wholly-owned subsidiary of Bristol-Myers, a pharmaceutical products corporation. MEC was one of several acquisitions by Bristol Myers in the medical devices area. In 1988, Bristol Myers authorized the MEC Corporation to purchase Cooper Surgical Specialties, a division of CooperVision International. The acquired assets included the Cooper-Aesthetech manufacturing facility in Paso Robles, California.

Cooper-Aesthetech was engaged in the production of plastic surgery items which duplicated to some degree MEC’s line. This acquisition markedly reduced the competition in the sector and concentrated a significant fraction of the international cosmetic surgery implant business in a single enterprise. The product line included the then controversial polyurethane foam-covered implants. The transaction was consummated for approximately $20 million.

The original Cooper-Aesthetech plant of Paso Robles beset with many administrative, personnel and technical problems. It had failed FDA inspections in 1987 and 1988. Information on regulatory entanglements with California regulatory agencies, the FDA and similar organizations in Canada and abroad, became public shortly after the acquisition.

Many devices sold to foreign markets incorporated major fabrication defects. Some were investigational items, others were production rejects. MEC documents confirm the existence of policies which habitually directed products with deviant attributes or defects to foreign markets. Liquidation of marginal products was also undertaken.

MEC subsequently transferred parts of the Paso Robles implant manufacturing operations to Racine, Wisconsin in 1990. Regulatory problems continued. The FDA later demanded pre-market documentation for breast implants. Documentation provided by MEC in response failed to acquire approval. A moratorium on further use of all silicone gel-filled implants was later enacted by the FDA. Production at the Racine facility was terminated in September 1991 and the assets were sold. Similar products are now made abroad and several former employees of Surgitek/MEC are involved in the new production locations .

Bristol Myers merged with Squibb Pharmaceuticals to become Bristol Myers Squibb in 1991. Difficulties from continuing litigation have surrounded the activities of the firm. Increasing numbers of claims of adverse reactions by users of the products are currently under investigation; numerous cases are currently filed with federal and state courts. It is generally understood that Bristol Myers Squibb is responsible for post-market follow-up of Surgitek products. The exact relationship between Surgitool, Surgitek, Travenol, Baxter Travenol, Baxter Healthcare and MEC is unknown.

Primary Product Lines - General Aspects:

Surgitek mammary implants were made by the Medical Engineering Corporation (MEC) of Racine, Wisconsin. These items appeared in 1970-73 and most early items embodied the same technology as the contemporary competing products. Many of the items were generic equivalents of existing popular designs. General Electric silicone-based materials as well as other materials intended for general industrial use were incorporated into the products until about 1976-77. Dow Corning elastomers and gel are found in later issues. Production was generally crude and the finished items often exhibited major defects. Some products had major safety, efficacy and durability problems and were withdrawn early. Some Surgitek products were initially named after prominent consulting surgeons for promotional purposes. Later nomenclature deleted such references.

Most of the corporate business from Surgitek is associated with breast surgery products. It is believed that these product lines account for more than 80% of total sales volume. A wide range of breast implants and accessories are listed in catalogs and with the acquisition of competing lines circa 1982, the Corporation was primarily a cosmetic surgery products manufacturer, prior to discontinuation of all of its product lines.

Secondary products include urology implants and genito-urinary devices for surgery. Included are penile implants, vaginal stints, catheters and products generally intended for reconstructive purposes. Other classes of manufactured items comprise cardiovascular implants and items for cardiothoracic life support. A much larger group of small volume devices are also comprised as part of the cosmetic surgery lines.

Typical examples include chin, malar, orbital floor, ear cartilage, nasal inserts for rhinoplasty and lines of custom-made implants mostly for cranio-facial and chest reconstruction. A significant number of these products are based on "gel in shell" technologies. In effect, much of the Corporation’s activity related to such implants amongst which are breast and chest defect devices, in addition to small facial implants assembled from shells that are later filled with soft silicone gels. Many of those devices remain on the market through secondary distributors. There is continuing manufacturing activity of these products outside of North America from successor corporations who acquired assets disposed of by the MEC operations.

The Perras-Papillon designs are amongst the earliest Surgitek plastic surgery items. They are described in a patent credited to the two plastic surgeons from Montreal, Canada. The devices are mechanically similar to existing products but the assembly methods and the shells material differ. They are a fixation type design and incorporate fixation fabric on the posterior side.

Commercial versions had shells made from polycarbonate-silicone copolymers. A complex array of fabric and adhesive were used to seal the shells at the mold extraction opening. The gel was unstable and reverted to reactive oil, the shell walls were thin and the polycarbonate-based polymer degraded rapidly and embrittled leading to drastic changes in properties.

Several modifications were issued and were sold until the early-eighties. Evidently, they were not widely used. Most ruptured early and were removed for medical reasons. The inflammatory reaction that followed shell perforation led to grossly contaminated breasts, oily granulomata and calcification of tissues with pathological conditions similar what is found in patients who received silicone oil injections . Such patients are occasionally encountered amongst long term users who present with advanced stages of breast diseases and undergo extensive breast resection because of large atypical tumors, advanced stages of oil dissemination or other late complications and adverse reactions of prostheses sold in the sixties and seventies.

These were made in small numbers by MEC from about 1972. They were spherical prostheses supplied as empty shells and provided with a separate container of gel precursor fluid. They copied some concepts used in an earlier Japanese product credited to Akiyama. They had valved shells similar to the contemporary salines and the "kit" included a container of conventional pre-catalyzed liquid gel precursors. The filled prostheses then required exposure to sterilizer temperatures in order to "vulcanize" the fluid and form the gelled substance deemed suitable for the claimed purpose. The product evidently did not sell well and was withdrawn discreetly circa 1974-76; recalls were never conducted.

Adverse reactions and cosmetic failures surround the product. It appears that the instructions for use were faulty and were routinely misinterpreted by surgeons. Instead of filling the shell and vulcanizing it before implantation, most users placed the shell in the surgical pocket and then filled it with the supplied material. Heat treatments were infrequently conducted.

This resulted in thin, oily and mobile filling substances with residual reactivity and intensely inflammatory properties. The mixture altered the shell elastomer and early ruptures were commonplace. Most Dahl "30000" Series prostheses were explanted early. Many users required extensive resection of granulomatous tissue that formed about the ruptured devices.

Other contemporary gel-filled round and oval/contour Surgitek products were conventional technology products similar to the competitors. Some were sold under surgeons ' names and took a significant market share. They later evolved into the main Surgitek product lines and sales continued until the early nineties.

The "10000" Series were oval antecedents to the popular round and "anatomic' gel prostheses. Several designs were released; some were listed under different product numbers in successive catalogs depending on year of production. On occasions, the same devices appeared in different sizes with confusing catalog numbers suggesting different Series. Most were thin wall, gel-filled prostheses similar to other common products already in the marketplace. The items were manufactured at the Racine, Wisconsin plant of the MEC. The devices were also called "Snyders", "Snyder designs" or "Snyder Technique" depending on the year of release. The "Georgiade Design" was another variant. It had an approximately equivalent shape with subtle shell differences and was marketed concurrently.

Unlike the round versions, the Snyders and oval devices had small orientation loops bonded to the bottom edge of the patch. This orientation loop leaked profusely and was a common site of failure for the devices. It eroded through the shell after a few years and a progressive tear advanced towards the equator from that point. The oval variants were made in smaller numbers than the round ones. Most early products also used General Electric silicone materials. The technology of fabrication differed slightly from the later issues bearing similar names. The quality of workmanship was extremely poor. Some items had scissor cut or torn components and permanently molded fingerprints were often noted on the adhesive zones. The gel fill hole seal, a small dot of adhesive used to close the shell after filling with the gel precursor, as well as the orientation tab bonding area, were notoriously irregular and frequently leaked for most items.

The performance of the early variants was no better than the later issues which used more precisely made components but thinner shells and Dow Corning materials. Very few of these items have ever been recovered in the unperforated state. The life expectancy before perforation was of the order of 4-6 years and the aggressive gel was notorious for systemic adverse reaction.