Product Identification: 

McGhan single and multi-compartment gel-filled and saline inflatable mammary prostheses were manufactured from about 1975 to 1996. Patch and shell markings, materials and assembly details as well as availability varied over the years. Several shell and patch designs were employed concurrently. Early versions had textured patches without markings. Some had the trademark "McGhan" on the patch. Some also showed "3M" on the logo until about 1984. 

Post-1984 products include other variations. The logo, when present on the patch, generally had only the McGhan trademark and the nominal size. However, a significant number of recovered items sold after1984 had features consistent with pre-1984 inventory items. 

It appears that these items were manufactured, at least in part, during the 3M ownership period but released as part of the new batches. This was further complicated by continuing late sale of 3M/McGhan inventory items pre-dating 1984. 

Patch and shell coding also varied depending on the year of production and the type. The devices could also have slightly different physical characteristics and appearance depending on the year, the selected raw materials and the mold mandrels. The absence of shell or patch markings could indicate custom or investigational devices in some variants. 

Highlights from the Mammary Prostheses Product Lines: 

The common round and contour shaped gel-filled prostheses of Style 80,81 and 82 were made first; they had much thinner shells than competing products. They reached their peak popularity in the late 70s and early 80s. The products ruptured and were returned in significant numbers. 

Saline-filled inflatable devices such as the Style 90 and 91were sold in smaller numbers but did not perform much better. Multi-lumen devices such as the Styles 70 and 76 were later added to the product line. Other saline-filled and barrier layer gel devices came in the late 70s. The Biocel™ textured surface variants were introduced in the mid 80s.  

Custom product lines were sold throughout the 70s and 80s; these included unusual reconstructive implants such as the "Birnbaum" as well as very large sizes. The gel-filled product lines were withdrawn circa 1991 following FDA pressure to regulate the cosmetic surgery implant sector. Saline-filled items, originally abandoned in the early eighties, were reintroduced in several new forms in the late eighties and remain available. 

Domestic U.S. marketing of gel-filled devices ceased in 1992 with the FDA Moratorium. However, in 1993, substantially equivalent products were still in commerce abroad. The corporation continues to distribute saline-filled prostheses in the USA undr the McGhan™ and the CUI™ trademark.

Corporate History: 

The McGhan Medical Corporation ("Old McGhan") was founded by former Dow Corning and Heyer Schulte employees circa November 1974. Initially involved in the production of ophthalmic implants, it manufactured its first batches of breast implants circa 1975. The primary facilities were located in Nevada and California. The assets of the McGhan Medical Corporation were acquired by the Minnesota Mining Corporation (3M) in June 1977. 

Much of the McGhan plastic surgery lines consisted of variations of similar devices commercialized earlier by others. The original devices used primarily General Electric (GE) elastomers, gels and accessory raw materials. Later versions used blends. McGhan also formulated their own materials derived from the GE technology. The parent 3M is also believed to have provided key polymer science knowhow to the operation in the late seventies. 

Most of the breast prostheses made during the early period had much thinner, more elastic shells than those of competing products. The devices fell into disfavor in the early-80s 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 appears to have motivated 3M, the parent corporation to divest itself of the plastic surgery business some time in 1982. 

Production nevertheless 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. The production resumed under the McGhan Medical trademark. 

In 1985, the assets were consolidated into the First American Corporation which was reorganized later into Inamed Corp. Parts of the operations were reorganized as separate units; 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, another breast prosthesis fabricator located in southern California, was absorbed into Inamed in the early 1990s.  

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. However, many of the McGhan products also included Dow Corning raw materials and 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.