Are Silicone Breast Implants Safe?
Some women choose to get breast implants either for breast reconstruction after a mastectomy, or for purely cosmetic reasons. Before making the decision to get implants, most women ask whether they are safe.
In the 1990’s, there was significant controversy about the safety of silicone breast implants and their alleged relationship to a variety of local and systemic problems. These problem included capsular contracture (hardening), rupture, asymmetry, and systemic problems such as connective tissue diseases. The end results of this controversy included the banning of silicone implants in the United States, numerous lawsuits and the bankruptcy one of the largest of the implant manufacturers.
The FDA, as well as health regulators outside the US, mandated safety studies. Those in Europe, Canada and elsewhere, soon proved the media and public outcry to be unfounded. Silicone implants were soon back on the market in those countries. The United States for many years remained the only country where silicone implants were still banned while the FDA mandated studies were being carried out by the two large remaining manufacturers, Allergan and Mentor. These FDA mandated studies demonstrated and corroborated the European studies that the current generation of silicone implants were safe and efficacious.
These implants, which have a more cohesive gel and a thicker shell than the original generations of implants, had over the course of the almost decade long study an incidence of capsular contracture (hardening) of 15% and a rupture rate of approximately 1% per year. Furthermore, no concrete relationship or statistical increase in CTD (connective tissue disease) was found.
The key points to take away from reading these studies was that breast implants may require replacement during the course of a patient’s life and clearly continually monitoring of the breast and the implant is prudent and necessary. More detailed information about the safety of breast implants and a more detailed list of the associated but much less common risks, can be found on the manufacturers’ or FDA websites (e.g., allegran or FDA).