The Food and Drug Administration has reconfirmed its stance that silicone breast implants are not dangerous a conclusion made by the deputy director of the FDA's devices division, Dr. William Maisel. The FDA has allowed implants to stay on the market despite the studies that have fallen short of their goals. Breast implants might not last for a lifetime as it could bring complications as it stays longer in a woman's breast, but no doubt, it is safe and effective to use.
Studies and concerns
Prior concerns about a link between silicone implants and autoimmune disease resulted in a ban on their sale in 1992. When years of clinical trials failed prove a connection between the implants and any serious medical conditions, silicone implants made by Mentor and Allergan were put back on the market in 1996.
Links to autoimmune disease, cancer and connective tissue disorder were of special interest in these decade long studies, but analysis of the results has found no strong evidence that the breast implants cause disease. According to these studies, silicone implants are safe and women should not be afraid to receive them.
Participation Rates in Studies
FDA General and Plastic Surgery Devices advisory panel discussed the follow-up safety studies for silicone implants that were provided by both Mentor and Allergan as they failed to conduct studies about the safety of implants. From this, Allergan was able to acquire a 60 % compliance rate for breast implant follow up compared to Mentor, which only have 25 % from their target 93 %. A scientist from Allergan said that there are two reasons behind this. Some women who used implants for cosmetic reasons do not believe they have to take the follow up. While, others would like to move on and forget the past after having mastectomy. Participation in the Mentor and Allergan's follow-up studies was lower than many experts would have like to see, but Allergan would like to drive their rate higher.
Participation in the follow-up studies was not mandatory, and the studies did require patients to receive regular MRI – an expense most participants had to pay out of pocket. Increasing patient participation in follow-up studies for those who have received silicone implants is a high priority for the FDA, and Mentor and Allergan have both been advised to make their follow-up studies more appealing.
Long and Short-term Care of Silicone Implants
Recovery time for breast implants can vary, but most patients recover fully within a few months. Stitches from the surgery will dissolve within a week, but swelling and bruising can continue for a few weeks. During the recovery time for breast implants, doctors recommend that patients adhere closely to their schedule of follow up visits and receive occasional MRIs to detect rupture in the implant. Patients should also watch out for extreme pain, asymmetry or sudden changes in their health.
In the long term, implants can harden, rupture, wrinkle, become infected or need to be removed. No implant lasts forever, and patients should plan to replace them eventually. Approximately half of the patients who receive silicone implants will need to have them removed within ten years, but with regular doctor visits and careful monitoring of any problems silicone breast implants are safe and should cause no serious long term health issues.
