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Information for Women About the Safety of Silicone Breast Implants
Some implants had internal dividers to keep the gel from sagginginto the central part of the implant. Seal patches were used to closeup any holes or slits left by manufacturers or the valve entranceto an expander, and are still used for manufacturing today's seamlessimplants.
By the late 1960s, Dow's shells had become less thick and were seamless. And in 1968, HeyerSchulte Corporation became the first domestic manufacturer of saline-filledimplants. Early saline implants were fragile and heavy, with audible“sloshing,” and there was a very high deflation rate of up to 76%, probablybecause of the high-temperature vulcanizing process used to “cure” or strengthen the contents.
The original thick-shell models were replaced in the 1970s and early1980s by implants with thin shells. But these had a greater tendencyto rupture and deflate. These “second-generation” implants were generally smooth surfacedand had high contracture and gel-fluid seepage rates. More flexiblegels were introduced by various companies from 1972 to 1975, andthinner elastomer shells were introduced starting in 1972.
Another development in the 1970s was a polyurethane foam coatingon the implant shell. This coating appeared to reduce contractureand was popular; an estimated 110,000 women or more received thistype of implant before it was discontinued in 1991. The polyurethanecoating appeared to diminish capsular contracture by causing an inflammatoryreaction. This reaction discouraged formation of fibrous tissue aroundthe capsule. But the polyurethane coating started disintegratingalmost immediately, so that what eventually remained was a mostlysmooth implant surrounded by a capsule containing foam fragments.Pain, fluid accumulation, and infection were reported. The foam fragmentswere one reason a polyurethane-coated implant was difficult to