In January of 1992, silicone disappeared from the market as the FDA placed a suspension on the synthetic compound, banning it from breast augmentation procedures. This ban was initiated in order to evaluate new safety techniques. There was speculation that silicone implants were causing connective-tissue diseases, so the FDA put the suspension in order.
By February, the FDA reevaluated the safety of silicone gel-filled breast implants. It was voted that silicone be removed from the market until further evaluation can be done. By the summer of 1992, after more research was conducted, the FDA found no sufficient data to support the hypothesis of the disease-causing implants. Thus, moving forward, the FDA continued access to silicone implants in July of 1992, but only for patients undergoing breast reconstruction or silicone implant replacement. In addition to the restriction, it was put to a vote that the patients undergoing the procedures are subject to be clinically studied. This is when saline implants were developed and substituted for new patients with the desire for breast augmentation surgery.
By 1998, the FDA approved the clinical study protocol for those with silicone implants. It also set a limit on the number of augmentation, reconstruction, and revision patients to a select number of locations. Through the course of several years, this was the practice for silicone implant procedures.
From 1998 to 2006, procedures were performed, studies were implemented, yet after the rigorous studying, the FDA failed to find evidence that proves the silicone gel-filled breast implants to pose health risks to patients. So, in November of 2006, the suspension was lifted. Once again, silicone implants were put back on the market, alongside the option for saline implants.
In January of 2011, the FDA issued a safety communication that stated that women with silicone gel-filled breast implants are at an increased risk of developing anaplastic large cell lymphoma (ALCL), which is a cancer of the lymphatic system in the scar capsule next to the implant.
With that information, FDA’s Advisory Panel held a meeting to conclude that the silicone gel-filled breast implants be created with a more cohesive gel. In conjunction, more studies would be conducted with patients undergoing the procedure to generate a more efficient safety protocol.
Today, women undergo breast augmentation, reconstruction, and revision surgery. With the past studies conducted to find a more efficient use of silicone implants, the procedure is safer. With that, you can rule out most of the dangers you think of when considering the surgery.