Both the medical and scientific communities have scrutinized silicone gel breast implants more than any other medical device in the world.
There is a mountain of data that has accumulated over the last four decades, and this data has been analyzed by multiple disciplines of professionals and scientists.
Mass media, class action lawsuits, the downfall of a major manufacturer of silicone gel breast implants, and the schizophrenic response of the Food and Drug Administration served to both confuse the public and intensify the scrutiny of these devices.
Silicone gel breast implants were first conceived and utilized by Dr.
Cronin in 1962 and have evolved through a number of different generations of structural and chemical improvements throughout the decades.
Initial implants were silicone oil soaked sponges that caused significant local scaring known as capsular contracture.
Subsequent improvements led to the creation of a device consisting of a silicone elastomer (synthetic rubber) outer shell that was filled with a mixture of silicone oils or gels.
These 'second generation' implants were still very leaky of silicone oils, and capsular contracture was still a major problem.
Improvements to the outer shell and the creation of semisolid silicone gels (cohesive) have lead to the 'low bleed' implant which, when compared to saline filled breast implants, has a very similar rate of capsular contracture.
Prior to a Congressional Act in 1986, medical devices were not regulated by the Food and Drug Administration and were not subject to the extensive safety and efficacy studies that drugs and medications were accustomed to prior to being placed on the open market.
Even without this mandate, prior studies had elucidated the biologic nature and safety of silicone in humans, and this had been confirmed by clinical results from breast augmentation surgery from around the world.
In 1992 however, a number of coincidental events lead to a unique situation in this country that changed the course of history for silicone gel filled breast implants.
While the Food and Drug Administration began its revue of these implants that year, a class action lawsuit was brought against Dow Corning, one of the manufacturers of these devices.
The primary allegation of the law suit was that silicone gel implants had caused severe debilitating injuries in thousands of women, predominantly autoimmune type diseases.
At this time, 'investigative reporting' was coming into its own, and this served to catapult this issue into the nightly news, informing the American public about these 'dangerous' devices.
The Food and Drug Administration's scientific revue committee recommended more research to be conducted by manufacturers while continuing production and sale of silicone gel filled breast implants.
The Commissioner of the FDA disregarded their recommendations, and placed a moratorium on silicone breast implant sale, citing the lack of sufficient data to prove safety and efficacy.
In the light of this, Dow Corning chose to settle the lawsuit out of court, which would eventually lead to its bankruptcy.
The FDA then invited the other manufacturers of silicone gel breast implants, Mentor and McGhan Corporations, to begin research that would last fourteen years.
Silicone gel filled breast implants are now widely available in the United States since their approval by the Food and Drug Administration in 2006.
Their approval was contingent upon continued voluntary research to be conducted by the manufacturers, and is concerned with the issues of implant durability and local complications, like capsular contracture.
Consensus among plastic surgeons like me, http://www.
drminniti.
com, who have performed thousands of silicone gel breast augmentations is that they are excellent devices that give women a more natural breast with great durability and longevity, and that they are extremely safe.
There is a mountain of data that has accumulated over the last four decades, and this data has been analyzed by multiple disciplines of professionals and scientists.
Mass media, class action lawsuits, the downfall of a major manufacturer of silicone gel breast implants, and the schizophrenic response of the Food and Drug Administration served to both confuse the public and intensify the scrutiny of these devices.
Silicone gel breast implants were first conceived and utilized by Dr.
Cronin in 1962 and have evolved through a number of different generations of structural and chemical improvements throughout the decades.
Initial implants were silicone oil soaked sponges that caused significant local scaring known as capsular contracture.
Subsequent improvements led to the creation of a device consisting of a silicone elastomer (synthetic rubber) outer shell that was filled with a mixture of silicone oils or gels.
These 'second generation' implants were still very leaky of silicone oils, and capsular contracture was still a major problem.
Improvements to the outer shell and the creation of semisolid silicone gels (cohesive) have lead to the 'low bleed' implant which, when compared to saline filled breast implants, has a very similar rate of capsular contracture.
Prior to a Congressional Act in 1986, medical devices were not regulated by the Food and Drug Administration and were not subject to the extensive safety and efficacy studies that drugs and medications were accustomed to prior to being placed on the open market.
Even without this mandate, prior studies had elucidated the biologic nature and safety of silicone in humans, and this had been confirmed by clinical results from breast augmentation surgery from around the world.
In 1992 however, a number of coincidental events lead to a unique situation in this country that changed the course of history for silicone gel filled breast implants.
While the Food and Drug Administration began its revue of these implants that year, a class action lawsuit was brought against Dow Corning, one of the manufacturers of these devices.
The primary allegation of the law suit was that silicone gel implants had caused severe debilitating injuries in thousands of women, predominantly autoimmune type diseases.
At this time, 'investigative reporting' was coming into its own, and this served to catapult this issue into the nightly news, informing the American public about these 'dangerous' devices.
The Food and Drug Administration's scientific revue committee recommended more research to be conducted by manufacturers while continuing production and sale of silicone gel filled breast implants.
The Commissioner of the FDA disregarded their recommendations, and placed a moratorium on silicone breast implant sale, citing the lack of sufficient data to prove safety and efficacy.
In the light of this, Dow Corning chose to settle the lawsuit out of court, which would eventually lead to its bankruptcy.
The FDA then invited the other manufacturers of silicone gel breast implants, Mentor and McGhan Corporations, to begin research that would last fourteen years.
Silicone gel filled breast implants are now widely available in the United States since their approval by the Food and Drug Administration in 2006.
Their approval was contingent upon continued voluntary research to be conducted by the manufacturers, and is concerned with the issues of implant durability and local complications, like capsular contracture.
Consensus among plastic surgeons like me, http://www.
drminniti.
com, who have performed thousands of silicone gel breast augmentations is that they are excellent devices that give women a more natural breast with great durability and longevity, and that they are extremely safe.
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