A Brief History on Silicone Breast Implants
The first silicone gel breast implant was introduced in 1962 by two plastic surgeons in Texas – Drs. Frank Gerow and Thomas Cronin. Timmie Jean Lindsey was the first woman to be implanted with them.
In 1976, the FDA enacted the Medical Devices Amendment to the Federal Good, Drug, and Cosmetic Act. This gave the FDA the authority to review and approve the safety and effectiveness data of new medical devices. Because silicone implants had been on the market for around 15 years, they were grandfathered in. Manufacturers were required to provide safety and effectiveness data, when called upon to do so by the FDA.
In 1982, the FDA proposed that silicone gel breast implants be classified as a Class III medical device. This classification would require that manufacturers prove their safety in order to keep them on the market. In 1988, silicone implants are officially classified as Class III medical devices. PMA’s (Premarket Approval Applications) from implant manufacturers were due by July of 1991. The PMA’s had to prove affirmatively, with valid scientific data evaluated by the FDA, that their devices were safe and effective. The FDA had 180 days to evaluate the data after the PMA was submitted.
In December of 1990, Connie Chung hosted a television program on the dangers of silicone implants. That same month, Representative Ted Weiss calls a congressional hearing on the safety of the implants.
In July of 1991, Dow Corning released 329 studies to the FDA. Two months later, the FDA came to the conclusion that the breast implant manufacturers’ safety data did not prove that the implants were either safe or harmful. The FDA told the manufacturers to submit more data.
By December of 1991, 137 lawsuits had been filed against Dow Corning. In January of 1992, David Kessler, the FDA Commissioner, called for a voluntary moratorium on silicone breast implants until the FDA and the advisory panel had an opportunity to consider newly available information. Breast implant manufacturers agreed to the moratorium.
In April 1992, Dr. Kessler lifted the moratorium on silicone implants. However, only women undergoing breast reconstruction and women getting replacement of silicone breast implants were allowed to get silicone. All of the implant recipients became part of a scientific study.
In June of 1994, the May Clinic study was published in the New England Journal of Medicine. The study found no increased risk of connective tissue disease and other disorders that were studied in women with silicone implants.
In 1995, the American College of Rheumatology issued a statement saying that the evidence is compelling that implants did not cause systemic disease. The Harvard Nurses Epidemiologic Study was also published in the NEJM that year, and it also found no increased risk of disease in women with silicone implants. In January of 1997, the American Academy of Neurology reviewed the existing silicone implant studies and reported that “existing research shows no link between silicone breast implants and neurological disorders.” In 1998, two large Scandinavian studies failed to show a link between silicone implants and neurological disease. In June of 1999, the Institute of Medicine releases a 400 page report prepared by an independent committee of 13 scientists. The report concluded that while silicone implants can cause localized problems (capsular contracture, breast scarring, etc), silicone implants did not cause any major diseases.
Fast forward to November 2006. The FDA approved Allergan and Mentor’s PMAs for silicone-gel filled breast implants. This was the first time silicone gel implants were available for augmentation, in addition to reconstruction and revision, since the moratorium was established in 1992. As conditions of approval, each manufacturer was required to conduct 6 post-approval studies to further characterize the safety and effectiveness of their silicone gel breast implants, and to answer scientific questions that the premarket clinical trials were not designed to answer.3
Today, we have a whole new generation of silicone gel breast implants known commonly as gummy bear breast implants, “gummies”, form-stable silicone gel breast implants, and cohesive gel breast implants. These implants are significantly different from the silicone implants initially marked in the 60’s. Today’s silicone is cohesive, meaning that in the event of a rupture, the silicone gel stays within the breast implant shell. The cohesiveness of today’s gel implants varies depending on the implant. Form-stable, or “gummy bear breast implants” are actually semi-sold, but feel soft and natural. All silicone gel implants that are not “form-stable” are still cohesive, just to a lesser degree.
What about gel bleed through the implant shell?
Minute amounts of silicone can bleed through the shell. The days of massive gel bleed are long gone. Back in the 1970’s, silicone implants bled quite a bit. These older implants feel slimy when held in hand. This is due to silicone oil bleeding through the implant shell. Silicone gel breast implants, all types of them, have come a remarkably long way in the decades past three decades.
Mentor performed a laboratory test to analyze the silicones and platinum (used in the manufacturing process), which may bleed out of intact implants into the body. The test method was developed to represent, as closely as possible, conditions in the body surrounding an intact implant. The results indicate that only the LMW silicones and platinum bled into the serum in measurable quantities. In total, 4.7 micrograms of these three low-molecular weight (LMW) silicones were detected. Platinum levels measured at 4.1 micrograms by 60 days, by which time an equilibrium level was reached and no more platinum was extracted from the device. Over 99% of the LMW silicones and platinum stayed in the implant. The overall body of available evidence supports that the extremely low level of gel bleed is of no clinical consequence.
2. “FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation.
3. “Breast Implant Chronology | Breast Implants on Trial.” Frontline. PBS.