Because the migration of liquid silicone was
perceived to be the cause of medical problems, and not the presence
in the body of the silicone compound itself, researchers resorted
to using silicone gel, rather than liquid, and developed a silicone
shell or elastomer to contain the gel and give it shape. The
silicone shell (a silicone rubber, like a balloon) was made
from the same chemical elements as the interior gel. Dow Corning
sold the first silicone gel mammary prosthesis, which was developed
by Dr. Thomas Cronin, in 1962.
Although the cosmetic results of the silicone gel implants were
the best yet achieved, they were far from perfect. For example,
many patients developed capsular contracture, or severe hardness
of the tissue surrounding the implant. To alleviate this complication,
manufacturers designed some implants with a polyurethane foam
coating that was designed to "mesh" with the surrounding breast
tissue and maintain softness. Unfortunately, the integration,
and degradation, of the foam into the surrounding tissue made
it impossible to completely remove the implant if necessary.
Additionally, implant manufacturers began receiving complaints
from plastic surgeons that their products were not soft enough.
In order to give the implants a more "natural" feel for better
aesthetic results, the manufacturers began designing the silicone
shells thinner, and the gel looser in consistency. With this
softness, however, was the added problem of weakness and low
tear strength. This resulted in a product that was at greater
risk for rupture as well as "gel bleed." Gel bleed is leakage
of silicone gel through an intact silicone shell or elastomer.
This "bleed" caused the exterior of the implant to have a greasy
feel. Many implant sales representatives felt this gave a negative
impression about the implants to their customers, the plastic
surgeons. It was determined that the "runnier," or softer the
gel, the more rapidly it would bleed from an implant. Thus,
if the envelope were thin, and the gel soft, the result would
be an implant that would bleed significant amounts of silicone
into the body of the woman in which it was implanted. As a result
of the complaints of sales representatives, and later the plastic
surgeons, each of the major manufacturers of breast implants
sought to develop an implant which did not bleed silicone gel.
Your Legal Rights
If you or someone you know has suffered serious side effects or an injury that you
believe may be related to silicone breast implants, you may be eligible to file a claim.