Silicone breast implants are back under the FDA’s microscope. Silicone implants were under original widespread use in the 1980’s and early 1990’s. Fears of silicone implants causing various diseases like lupus and arthritis prompted the FDA to ban the use of them in 1992. After analyzing studies by the two major breast implant manufacturers (Mentor and Allergan), the FDA lifted the moratorium on silicone breast implants in 2006, ruling them safe and effective, on the condition that 10 year post-approval studies were performed.
An FDA Panel recently met with patients, plastic surgeons, and representatives of Allergan and Mentor to discuss the results from the post-approval studies. CNN.com has an excellent article about their findings, summarized below:
- Mentor, Allergan admit they’ve lost track of many patients
- Manufacturers had promised to do major 10-year studies
- Panel hears from both doctors, patients that are highly concerned, quite pleased
- FDA says it has much to consider
To read the rest of the CNN.com article, click here.
