FDA update on breast implants – 2011

When the FDA re-approved silicone breast implants for general use, back in November of 2006, one of the conditions was that the two major manufacturers and the FDA would co-operate to do some ongoing follow-up studies about implant safety and effectiveness. Now, approximately 5 years later, the FDA has released an update, discussing the first installment of this data.

In a nutshell: it confirms what we knew 5 years ago. Implants, when used correctly, are safe devices…but they’re not perfect.

The report says the same things we tell patients at their consultations for breast augmentation

1) Implants don’t last forever. They get old, become brittle, and eventually need to be replaced. This means more surgery, at some point in the future.

2) They can get in the way of mammograms. Other imaging techniques, like MRI and ultrasound, are very helpful in examining the implant and hard-to-see breast tissue.

3) The implants can get hard, due to capsular contracture, in a minority of patients. This is still the most frustrating, unsolved problem of breast implant surgery, long-term.

And these issues are also true for saline filled implants, as well.

Good news: the FDA study continued to find no linkage at all between silicone gel implants and breast cancer, or between silicone gel breast implants and auto-immune diseases, such as lupus, scleroderma or rheumatoid arthritis.

The FDA website has much more details. Their consumer page is here.

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