Breast Augmentation and Liposuction Blog - Dr. Bottger

The FDA has released a safety update on silicone gel breast implants, the first since the lifting of the moratorium in November 2006. The update is derived from results of a 10-year study of Allergan's silicone gel breast implants and an 8-year study of Mentor's silicone gel breast implants, enrolling a total of nearly 2000 patients. The report looks at silicone gel breast implants as medical devices, not at breast augmentation as a cosmetic surgery, so it looks at only part of the story for women considering breast augmentation. However, this aspect of breast implants is extremely important, and we will take several months to consider a number of elements in the report to help women understand the potential risks and complications of breast augmentations.

To me, the most crucial statement by the FDA is "The benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use." After decades of uncertainty about possible diseases or conditions related to breast implants, the FDA now feels we know enough about them to make definitive recommendations, and eliminate lingering doubts about autoimmune and connective tissue disorders.

Here is a summary of the report's other key findings:

• "Silicone gel breast implants have a reasonable assurance of safety and effectiveness," "Despite frequent local complications and adverse outcomes."
• Risks of complications and adverse outcomes increase with time: "Women with breast implants will need to monitor their breasts for local complications for the rest of their lives."
• The most frequent complications and adverse outcomes are:
• Capsular contracture
• Reoperation
• Implant removal
• Breast implants may increase the risk of anaplastic large cell lymphoma (not breast cancer), which nonetheless remains very small
• Up to 20% of breast augmentation patients are expected to need a second surgery within the first 8 to 10 years, but routine replacement is not necessary
• There is no association between silicone gel breast implants and connective tissue disease, breast cancer, or reproductive problems, but it remains possible that very rare or very slow-developing conditions may not be detectable in the current data
• MRI remains the only effective method for detecting silent rupture of silicone gel breast implants

The FDA also notes that very low follow-up rates (66% for the Allergan study and 58% for the Mentor study) may limit our ability to interpret the data.

If you are considering breast augmentation and want to learn more about what these results mean for you, please schedule a consultation with board-certified plastic surgeon Dr. David A. Bottger today to have your questions answered in person.

Labels: breast augmentation, safety, silicone breast implant