FDA Approval of Silicone Breast Implants Reflects the Times

Years after thousands of women participated in the Breast Implant class action, with injuries that ran the gamut from rupture leading to re-implant surgery to severe immune disease, the FDA has now essentially white washed the product for use by women as they choose. It has now approved the use of silicone for cosmetic breast enhancement surgeries.

Many women will now have the choice to use silicone or saline for their breast enhancements. Previously, the FDA banned the use of silicone for cosmetic breast enhancements because of the health risks associated with possible leaks. Today, the FDA takes the position that they are “reasonably assured” that silicone breast implants are safe. My experience concerning women injured by these implants both from my clients and as viewed in the seminars I have attended is very much at odds with a clean bill of health for this product.

Women now considering silicone implants will experience ruptures just as they did when these implants were previously marketed. My experience is that the silicone can become systemic, with lumps of the stuff appearing in places and times that it is not expected. Certainly women choosing this implant should educate themselves about the risks involved in choosing silicone implants. They should also consider the necessary and costly medical treatment that goes hand in hand with the product. For example, in the event that a silicone breast implant ruptures, the woman may not experience any immediate symptoms. It is possible that the rupture is initially detected only on MRI examination. These are now important studies in detecting ruptures and a decision to choose silicone breast implants will subject the woman to a lifetime of MRI examinations. The FDA states that the first MRI examination is to be conducted three years after the surgery. In addition, the FDA recommends an MRI be conducted every two years thereafter. Not only will the cost of MRI’s exceed the cost of the initial breast enhancement surgery, but women may have to pay these costs out of their own pockets. Obviously, as has been the case previously, ruptured implants portend additional surgeries with additional scarring and potential disfigurement.

Furthermore, women must be aware of the risks of physical injury involved with possible ruptures. Women may be subjected to multiple operations, hardening of the area around the implant, changes in nipple and breast sensation, and as discussed above, rupture with or without symptoms and possible migration of the silicone in the woman’s body.

The two Santa Barbara manufacturers that will benefit from the FDA’s decision are Mentor Corp. and Allergan Corp. The FDA considered four years of data from Allergan Corp. and three years of data from Mentor Corp. to determine that the FDA had reasonable assurance that the silicone implants are safe and effective. Consumers should take notice that the FDA has required both companies to continue collecting data to assess the long-term clinical performance of the product. Among other conditions, the companies must also conduct studies of 40,000 women through ten years. The FDA explained the following regarding post-studies:

“The large post-approval studies will gather data on long-term local complications, connective tissue disease and its signs and symptoms, neurological disease and its signs and symptoms, reproductive issues, offspring issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and rupture results.”

As the number of breast enhancement surgeries increase, many women will be confronted with the decision to choose silicone implants. They must make well informed decisions about possible complications and neccessary treatment for silent ruptures. Since Allergan Corp. and Mentor Corp. are required to conduct further in-depth studies, women must take caution that the post-studies may reveal pertinent information about the medical consequences of ruptured silicone breast implants.