Origin of CUI - Early Phase:

On August 20, 1974, American Hospital Supply acquired the assets of Heyer Schulte and undertook a reorganization. Dissension arose amongst some staff members and culminated in the departure of key Heyer Schulte staff, including senior technical managers. Some of these individuals subsequently founded competing corporations which emerged as important factors in the breast prostheses industry.

One such individual was James Cox who founded the original Cox Uphoff Corporation (CUI) on or about September 18, 1975 in Santa Barbara, California. It consisted mostly of former employees from the Heyer Schulte Corporation. Key individuals besides James Cox included Robert Uphoff and Thomas Salisbury. Later, other former AHS employees involved in the foundation of Cox Uphoff left to found additional breast implant corporations. For example, Thomas Salisbury reappeared as a founding member of the Aesthetech/Natural-Y corporations, another contemporary competing group.

Product Lines:

CUI initially performed contract work for other manufacturers of breast implants including Dow Corning and Natural-Y Surgical Specialties. By the late-seventies, CUI was producing mostly silicone-based plastic surgery items for sale under its own tradename. A separately incorporated network of European distributors was later established and operated under CUI (Europe) from a central facility in the United Kingdom (Isle of Man). The commercial activities of CUI were combined with other marketing functions involving different classes of medical supplies. Most of these European organizations are believed to be directed principally by former Dow Corning European sales representatives.

Product lines for CUI include conventional gel-filled prostheses of several styles, double lumen implants, saline inflatable prostheses and tissue expanders. Small implants for non-breast plastic surgery and peripheral items for breast implantation have also been distributed under the CUI labels since the late-seventies.

Highlights of the period include contract fabrication of saline type and multi-lumen breast prostheses on behalf of Dow Corning and the continuation of foam-coated implant lines originally started by the Heyer Schulte Corporation in the late-sixties. Foam-coated implants were produced in special variations on behalf of the Natural-Y Corporation and continued a contract relationship that Natural-Y had originally developed with Heyer Schulte, primarily through Thomas Salisbury. During this time, the modified "Ashley" Natural-Y prosthesis was made. However, Cox Uphoff did not sell such prostheses under its own labels.

Many styles of custom prostheses with and without foam coatings were made in small numbers using existing CUI shell styles. Records of the time suggest that these devices were made with the knowledge of the Natural-Y Surgical Specialties group as part of the sub-contract relationship. Devices of this kind were inventoried for a long time and some reappeared in commerce as late as the mid-eighties. Subsidiary facilities were created between 1985 and 1990, most were distributorships. Some were located in Nevada, the northern Mariana Islands, the Netherlands and possibly other offshore sites.

In the mid-eighties, the North American operations encountered financial difficulties. Litigation surrounding injury claims from their implants and patent infringement litigation were principal factors and the U.S.-based Corporation entered into a Chapter 11 protected bankruptcy status which lasted from January 1990 to June 1991. Cox Uphoff Corporation (America) was then taken over by another breast prosthesis manufacturer, the McGhan Medical Corporation (Inamed), and a reorganization followed. The integration of the North American Cox Uphoff International (CUI) operations was completed circa 1992 and the product line is now under the Inamed Group.

Products manufactured by Cox Uphoff, currently known as the CUI Division of Inamed, were largely imitations of existing products on the market at the time. Rationalization of product lines resulted in deletion of large portions of the catalogued items and integration of fabrication techniques. Performance and risk of these items was comparable to other devices of the class. Failures were frequent. Double lumen and saline devices were also the cause of chronic and sustained infections and account for a significant fraction of adverse reaction reports.

Manufacturing errors leading to the release of defective products with adverse reactions are reported and entail a comparable morbidity level to that of its competitors. In late-1991, gel prostheses were discontinued shortly before the Moratorium on silicone gel device usage by the U.S. FDA. The Moratorium remains in effect since 1992.

Late Period and Background on the Current Parent Corporation (Inamed):

Cox Uphoff Corporation was acquired by the Inamed Group on or about May 25, 1989. The merged corporations, as well as related distribution and foreign operations, were consolidated under the corporate name of Inamed circa 1990. The original CUI production facility remains in operation in Carpinteria and production appears integrated with other Inamed related plants in Goleta, California. These plants are now engaged primarily in the production of saline-filled devices. There are several offshore subsidiaries which act primarily as specialty manufacturers and European distributors of Inamed and CUI products.

The Inamed Group has a convoluted history. It began as the McGhan Medical Corporation (old McGhan). It was founded by a consortium of former employees from Dow Corning and Heyer Schulte in November 1974. Initially involved in ophthalmic implants, it manufactured its first batches of breast implants circa 1975. Its primary production facilities were located in California. The assets of the McGhan Medical Corporation were acquired by the Minnesota Mining and Manufacturing Corporation (3M) in June 1977.

Much of the McGhan plastic surgery lines consisted of variations of similar devices commercialized earlier by others, including Cox Uphoff. The original devices used primarily General Electric (GE) elastomers, gels and accessory raw materials from other suppliers. Later versions used blends. McGhan also formulated its own materials derived from the GE technology. The parent 3M is also believed to have provided key polymer science knowhow to the operation. CUI also purchased intermediates from alternate supplies such as Admiral Silicones.

Most of the breast prostheses originating from these centers during the early period had very thin elastic shells with significantly different properties when compared to competing products. The devices fell into disfavor in the early-eighties amid reports of ruptures and litigation surrounding the product line. The problems later spread to the saline-filled lines and embarrassed surgeons also filed suits against the manufacturers. Concern surrounding this litigation and future liability exposure appears to have motivated 3M, the parent corporation, to seek divestiture of its plastic surgery business beginning in 1982.

Production continued under the 3M/McGhan trademark until August 1984. The plastic surgery products divisions were then sold to a new consortium formed by the original owners, Donald McGhan and associates. Production resumed under the McGhan Medical trademark.

In 1985, the assets were consolidated into the First American Corporation which was later reorganized into Inamed Corp. Parts of the operations were split-off as separate groups; Nusil™, the materials group responsible for supplying the silicones became a separate entity. Other fragmentary corporations were later merged into Inamed. Nevada-based and off-shore divisions (Ireland) were created and Cox-Uphoff International, one of its earlier competitors, was absorbed into Inamed in the early-nineties.

Unlike other manufacturers such as Heyer Schulte and Cox Uphoff, McGhan had the capacity to produce its own silicone materials for breast prostheses and other medical devices. Such materials were used widely for their own products and were also sold to other manufacturers including Cox Uphoff. However, many of the McGhan and the Cox Uphoff products also included Dow Corning raw materials. Elaborate searches of corporate production (lot history) records have to be examined in detail to establish the identity and the source of components that entered into specific issues of their products.

Cox Uphoff is currently one of approximately nine manufacturers of saline-filled prostheses, some of which are sold domestically. It also sells gel-filled prosthesis in Europe and the Far East through its European divisions.

Users of early Cox Uphoff-made implants may be eligible for compensation under MDL 926. Depending on the year of manufacture, and the type of device, inclusion in Dow Corning and Inamed sub-classes may be appropriate. Situations involving users of implants manufactured by Cox Uphoff on behalf of Dow Corning are specifically eligible under Dow Corning classes. Individuals with devices manufactured in the early-eighties may be eligible under the "Bankruptcy Class/Bioplasty". Conditions of participation and compensation scales have not been published at the time of writing. Additional research regarding European operations is required in order to clarify compensation issues for European and Far Eastern users.

Cox Uphoff made foam-coated implants in various times, both under sub-contract and on a custom basis. Circa 1970-73, James Cox and Thomas Salisbury, while employed at the Heyer Schulte Corporation, became fluent with manufacturing of the Pangman Polyplastic foam-coated/foam core implants and the gel-filled analogs known as the "Ashley Natural-Y" prostheses. These products were evidently made but not sold directly by Heyer Schulte. Subsequently, Heyer Schulte became part of American Hospital Supply and was renamed American Heyer Schulte. The Polyplastic implant made by these firms was 'name branded' on behalf of Codman and Shurtleff (now a Johnson & Johnson subsidiary). The Ashley Natural-Ys were 'name branded' on behalf of Weck Surgical (now a Bristol subsidiary).

Circa 1976, James Rudy, a senior executive for the American Heyer Schulte Corporation, terminated all contracts and formal associations with the foam implants. However, American Heyer Schulte continued to manufacture foam- coated devices on a semi-production and custom basis. These included the Pennisi and the Capozzi designs which were types of gel-filled and saline- filled implants partly coated with the same foam. These products were sold by American Heyer Schulte up to the late-seventies/early-eighties.

Circa 1976-77, James Cox left American Heyer Schulte and founded the Cox Uphoff Corporation, the precursor to Cox Uphoff International (CUI). Other members of American Heyer Schulte followed, including Thomas Salisbury. During the period 1978-80, Cox Uphoff manufactured versions of the Ashley Natural-Y and the Vogue variant on behalf of the Markham corporations and on behalf of Joseph Cavon.

Circa 1979, Thomas Salisbury left Cox Uphoff and founded the Aesthetech Division of the Aesthetech/Natural-Y group, also known as the "Markam' corporations. These corporations eventually became part of the Bristol Myers group through successive acquisitions involving Mark-M, Markham International, Aesthetech, Natural-Y Surgical Specialties, Cooper and the Medical Engineering Corporation.

It appears that polyurethane- coated implantscontinued to be made by CUI on a custom basis following the departure of Thomas Salisbury. In the mid-eighties, CUI encountered difficulties from litigation surrounding injuries from its products. It entered into a Chapter 11 protective reorganization. Circa 1987-89, the Inamed Group consisting of McGhan Medical, acquired Cox Uphoff International. CUI thus became part of the Inamed group. The European CUI operation based in Douglas, Isle of Man, was dissolved and reincorporated as part of Inamed Europe. Together these corporations are now known as Inamed. They still manufacture breast prostheses including saline inflatables and silicone gel types under other trade names.

The history of CUI during the period 1977 to about 1988 is not well documented. According to MDL 926, all foam-coated products from the eighties are credited to Bristol. Therationale for this attribution is not stated. Perhaps it reflects an indemnification agreement.