In the 1960’s, physicians realized that foreign liquids inside the breast should not be free floating, but instead encased in some kind of “bag.” This was the birth of the first breast implant that resembles the modern devices, and in 1962, Timmie Jean Lindsey became the first woman to receive breast enlargement using silicone implants. The mother of six was operated on at the Jefferson Davis Hospital in Houston, Texas. Over a two-hour timeframe, Lindsey went from a B to a C cup size.
Ironically, Lindsey did not intend to have breast enlargement surgery. In fact, she went to the hospital “to get a tattoo removed from her breasts, and it was then that doctors asked if she would consider volunteering for this first-of-its-kind operation.” According to Lindsey, “I was more concerned about getting my ears pinned back… My ears stood out like Dumbo! And they said, ‘Oh we’ll do that too.’ So, a deal was struck.”
The two pioneering surgeons, Frank Gerow and Thomas Cronin, deemed the operation a success, and Gerow said the “implants were ‘as harmless as water, and more than fifty years later, Lindsey remains happy with the results. https://www.bbc.com/news/magazine-17511491.
Even though breast implants made with silicone envelopes and filled with silicone gel or saline (salt water) were first sold in the United States in the 1960s, sales were relatively slow until the 1980s. https://www.ourbodiesourselves.org/book-excerpts/health-article/facts-about-breast-implants/
In 1988, silicone implants were re-classified into a Class III category, which meant that in order to stay on the market, their safety had to be proven.
In January 1992, the FDA called for a voluntary moratorium on the use of silicone gel breast implants until safety has been reviewed.
In 1997, the U.S. Department of Health and Human Services (HHS) appointed the Institute of Medicine (IOM) of the U.S. National Academny of Sciences (NAS) to investigate the potential risks of operative and post-operative complications from the emplacement of silicone breast implants. The IOM’s review of the safety and efficacy of silicone gel-filled breast implants, reported that the “evidence suggests diseases or conditions, such as connective tissue diseases, cancer, neurological diseases, or other systemic complaints or conditions are no more common in women with breast implants, than in women without implants” subsequent studies and systemic review found no causal link between silicone breast implants and disease.
In 1999, the Institute of Medicine published the Safety of Silicone Breast Implants (1999) study that reported no evidence that saline-filled and silicone-gel filled breast implant devices caused systemic health problems; that their use posed no new health or safety risks; and that local complications are “the primary safety issue with silicone breast implants”, in distinguishing among routine and local medical complications and systemic health concerns.”
In 2006, …the U.S. Food and Drug Administration lifted its restrictions against using silicone-gel breast implants for breast reconstruction and for augmentation mammoplasty.
Between 1992 and 2006, silicone implants were restricted to clinical trials that were primarily for cancer patients and women with broken implants. Patients were required to be informed that the implants were not approved by the FDA and to be regularly evaluated by their plastic surgeons as part of the study, in order to provide safety data intended to help all women with gel implants.
After over a decade out in the cold, silicon was allowed back into breast implants in 2006 — but in a new form. The FDA, after years of study and experiments, finally allowed silicone gel-filled implants onto the U.S. market. They and saline are now your two choices for modern breast implant surgery.
In January 2011, the FDA issued a Safety Communication on anaplastic large cell lymphoma (ALCL) in women with breast implants. Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.
In 2013, the FDA approved a silicone gel-filled breast implant that uses a more cohesive silicone gel, compared to their previously approved breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their breast implant.
In 2015, nearly 280,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants and about 106,000 breast cancer patients had reconstruction after mastectomy, often with implants. The popularity of breast augmentation has nearly tripled since 1997, when there were just over 101,000 of these procedures.
By 2017, according to the American Society of Plastic Surgeon, there were 17.5 million cosmetic procedures in the United States. Of that number, breast augmentation wasthe top cosmetic surgical procedure and has been since 2006. In 2017, silicone implants were used in 87%, and saline implants in 13%, and the number of breast augmentation cases is up 3% from 2016 to 2017.
Statistically, the numbers are as follows:
Breast augmentation (Augmentation Mammaplasty): 2017 – 300,378 performed; 2016 – 290,467 performed; 2000 – 212,500 performed
Breast implant removals (Augmentation patients only): 2017 – 27,507; 2016 – 28,467; 2000 – 40,787
Breast lift (Mastopexy): 2017 – 105,219; 2016 – 101,264; 2000 – 52,836
Breast reduction (Aesthetic patients only): 2017 – 43,635; 2016 – 39,148