GENERAL OVERVIEW:
SILICONE BREAST IMPLANTS
Please select a link:
»
TYPES OF IMPLANT PROBLEMS
»
HISTORY OF SILICONE IMPLANT LITIGATION
SILICONE BREAST AUGMENTATION
Society has long been in search of ways in which to enlarge women's
breasts. Silicone was first used for breast augmentation in Japan
in the late 1940's where it was injected in liquid form into the
breasts of many Japanese women. Silicone injections were subsequently
used in the United States beginning in the 1950's when they were
introduced to Las Vegas showgirls. It was soon discovered that
serious medical problems resulted from the migration of liquid
silicone to other parts of the body. As a result, silicone injections
were ultimately banned in the United States in the 1960's.
Nonetheless, efforts to develop a successful breast augmentation
method persisted. 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.
In 1976, the Food
and Drug Administration (FDA) was authorized to issue
regulations classifying all medical devices into one of three
designated risk categories, the highest of which (Class III devices)
would require proof of safety and effectiveness. While silicone
injections were immediately classified as Class III devices, breast
implants were "grandfathered" into the market, virtually
excusing manufacturers from justifying their products.
The FDA was aware of concerns related to breast implants by the
late 1970's when scientists and physicians expressed concerns.
In 1982, the FDA finally published a proposed rule to classify
silicone breast implants as Class III devices. It was not until
June of 1988, however, that the FDA formally classified silicone
and saline breast implants as Class III devices -- approximately
ten years after the FDA had first been notified of possible dangers.
The FDA's Class III classification did not mean that breast implants
would be immediately removed from the market. It only meant that
manufacturers would be required to submit premarket approval (PMA)
applications demonstrating the safety and effectiveness of their
product. Before the manufacturers could make their case for the
implants, however, the FDA had to publish guidelines outlining
the risks associated with breast implants and describing what
the manufacturers would need to establish to obtain approval.
The FDA undertook its obligations in a pedestrian manner and this
final regulation was finally published on April 10, 1991. The
manufacturers were then given 90 days in which to formulate their
positions. Throughout this process, silicone breast implants remained
on the market.
In August 1991, the FDA rejected the PMA applications for polyurethane
foam covered implants, which meant that these products could no
longer be sold. On January 6, 1992, the FDA announced an indefinite
moratorium on all silicone breast implants. In April 1992, the
FDA agreed to permit the use of silicone breast implants in a
few narrow circumstances. Silicone implants can be used for reconstruction
in women who are deemed unsuitable candidates for saline implants.
Additionally, the women who now receive silicone gel breast implants
must participate in a clinical study sponsored by the manufacturer
and approved by the FDA. Silicone gel filled implants are no longer
available for purely cosmetic augmentation.
Saline implants are still available for either
reconstructive or cosmetic augmentation, but the FDA has demanded
proof of safety and effectiveness from the saline implant manufacturers.
To date, the safety of saline filled implants has not been proven.
As saline implants are designed with a silicone envelope, long-term
health effects have yet to be investigated, and they may not be
without risk. Additionally, they are also more prone to rupture,
after which surgery is required for replacement.
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.
CLICK
HERE TO CONTACT THE PRODUCTS LIABILITY LAWYERS NOW FOR A FREE CASE
EVALUATION, OR CALL US AT 1-800-955-0815.
» top
