Early Saline Implants: 

Saline-filled mammary augmentation devices first appeared commercially in France circa 1965. Made by Simaplast S.A., they consisted of a simple silicone bag made by joining two half-shells and forming a filling tube integrally by bonding the supplemental strip extending from the perimeter of each half shell. Closure was achieved by knotting this seamed tube or by insertion of a solid Teflon™ plug. These devices were credited to H. Arion, a French physician. These were imported to the U.S. by Roger Klein Associates Corporation which later became the Mammatech Corporation. Their products were distributed in North America from about 1967. A small number of evolutionary variants were made during the period 1967-72. Very small numbers of these items appeared in commerce. Most were limited to "spot" clinical investigations. A small number appears to have distributed through conferencs and by personal contact with foreign distributors and clinicians. The last variant associated with H. Arion is described in U.S. Patent 3,860,969 which was granted on January 21, 1975. It consists of a device with a central posterior tube intended to be coiled into a posterior recess; the shell of this class of device was manufactured from General Electric polycarbonate-silicone copolymer.  

Some later variants produced by the Simaplast Corporation copied design elements from the "Jenny" style inflatable implants which were then made commercially by the Heyer Schulte Corporation. Late implants were sold under the brand of Mammatech and may have been made in part at U.S. plants, possibly under sub-contracts. The product line was later broadened to include other variations of saline and gel implants which are not of the Arion designs. 

The fabrication technology of the most widely sold Mammatech Inflatables was based on acetoxy catalyzed room temperature vulcanizing silicone (RTV) shell materials but the products were not consistently made. Some incorporated large amounts of mineral fillers. These considerably enhanced the osmotic permeability of the shell and drastically reduced durability. Early versions employed Dow Corning silicone materials. General Electric silicones were substituted some time in the seventies. Dow Corning silicone constituent materials reappeared in the late-seventies. Performance of the devices was erratic and shell material frequently calcified or degraded; components suffered embrittlement and deflation frequently took place after 3-6 years in situ. Many of the saline devices were explanted after prolonged chronic infections. 

Competing corporations copied the Arion concept and introduced modifications to the valve/filling port. These became commercially available in the seventies. A range of similar saline-filled devices appeared in the mid and late-seventies. Dow Corning, 3M/ McGhan, Cox-Uphoff and the Medical Engineering Corporation, as well as foreign corporations such as PMT Corp, Perouse and Eurosilicone S.A., introduced variations on the original concepts of Arion. Further modifications copied designs credited to Birnbaum, Tabari and Jenny which had followed the Simaplast products. Valves were re-designed to circumvent patent aspects or to reduce costs. More difficulties were encountered, in particular valve failure and shell rupture. Litigation emerged as a significant cost factor in the late-seventies and claims came from physicians as well as patients.

By the early-eighties, most corporations had discontinued the salines. Klein/Mammatech products were discontinued and the distributor was forced into receivership following the publication of papers on fungal infections associated with the use of their products. A few other firms continued to market saline inflatables but the products were rarely seen in clinical practice until the FDA Moratorium on gel-filled prosthetic systems.  

Improvised Applications as "Tissue Expanders" 

Saline devices with Klein/Simaplast style filling tubes were once employed as "tissue expanders". This was done by severing part of the filling tube and coupling the stem to silicone tubes sometimes externalized through the an opening for post operative filling. Hickman-type percutaneous catheters or Port-a-Caths™ designed for percutaneous drug delivery were also used later added and buried in tissue at sites remote from the implant (axillae, abdomen).  

Results were disappointing and adverse reactions (infective episodes) were encountered in large numbers. Later, tissue expanders may have been commercialized by Simaplast/Klein but were not sold in large numbers. Competing corporations such as Heyer Schulte and Surgitek made copies and took the larger market share. These products were based on fundamentally different technologies. They were designed for post implantation filling using percutaneous injection ports. The ports were generally linked to the main prosthesis with a silicone conduit.  

All of these devices were virtually impossible to keep sterile. Failure was also an early occurrence because of the high injection pressures and the complexity of the shell assembly which led to frequent production faults. The incomplete filling of the shell which led to extensively pleated and "puckered" implants constrained within capsules and the stresses created by the filling appendages also contributed to early failures within this class of product.  

Injury Compensation Under MDL 926 and other U.S. or Canadian Settlements 

The Klein/Mammatech Corporations are deemed to be under receivership and are not participants in MDL 926. The primary manufacturer, Simaplast, is a French-based corporation which is continued under several other European-registered corporations. Foreign manufacturers of this kind are fluid organizations and extraterritorial claims are difficult to process. There are "long-arm statutes" which may give U.S.-based plaintiffs jurisdiction over countries that voluntarily do business in the U.S. This area, however, requires exploration.  

Information originating from the Claim Administrator and Committees of MDL 926 suggest that compensation may be possible under special provisions made for the Bioplasty Claimants. Bioplasty, a non-solvent defendant, was listed as a Released Party under Exhibit B of early agreements. Thus, U.S. Bioplasty claimants are deemed eligible for certain benefits. Similar eligibility for patients with Klein, Mammatech and other products made by non-participating device manufacturers has been discussed as part of the "Market Share Compensation Program". However, late 1995 revisions in MDL 926 do not provide a firm policy in this area.  

The status of non-U.S., Simaplast, Klein and Mammatech plaintiffs under the U.S. Revised Breast Implant Settlement Program (1996) and the Canadian-based partial settlements is not specifically addressed.