Dr. Chang offers his patients the choice between saline and silicone filled breast implants. Within the context that both types of implants are medical-type devices, he believes that both implant types are generally safe. The percentage of patients asking for silicone implants has increased in the past three years, and Dr. Chang is now placing more silicone implants than saline.
Silicone filled breast implants were first developed and implanted in 1962 by the Dow Corning Corporations. In response to surgeons’ requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner, less cohesive gels and thinner shells. These implants, unfortunately, had a greater tendency to rupture or “gel bleed” silicone through an intact implant shell, and complications such as capsular contracture were quite common. It was predominantly implants of this generation that were involved in the American class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s.
In order to ensure the safety of silicone implants, the FDA issued a 1992 moratorium on the placement of silicone breast implants for cosmetic purposes. The silicone implants were still approved for reconstruction purposes and there were studies closely following those patients. In the meantime, the manufacturers continued to improve their gel-filled products, developing more cohesive gel implants, and continued with their studies on safety.
By 1999, the IOM study of the FDA stated that there was insufficient evidence to establish that either saline implants or silicone implants caused systemic health effects and that there was no new health or safety issues associated with the use of either type of implants.
The IOM concluded that local complications are “the primary safety issue with silicone breast implants”, making a clear distinction between local complications and systemic health concerns.
On November 17, 2006, the moratorium was lifted, making silicone implants once again available to patients. The approval was given with a number of conditions, including a requirement to complete 10-year studies on women who have already received the implants and a 10 year study on the safety of the devices in 40,000 women.
The post-approval studies will be closely monitored by the FDA. The FDA warned that the silicone implants are not without risk and that women receiving them should have periodic MRI exams to watch for any signs of rupture or leakage. It was also mandated that patients be given brochures explaining the risks.