January 28, 2011
FDA ADVISORY STATEMENT
issued an advisory statement on Wednesday January 26th 2011 to all health care practitioners and the public about a possible link between breast implants and ALCL Anaplastic Large Cell Lymphoma
(a form of Non-Hodgkins Lymphoma). This is an extremely rare condition and patients with breast implants
are to be reassured.
SMALL INCREASED RISK
The FDA found a small correlation between both saline and silicone implants of 34 cases in 10 million women over 25 years emphasizing how rare a condition it is and that it is NOT breast cancer.
Most patients sought treatment for delayed changes in their breast after having implants placed. Symptoms included swelling, pain, asymmetry, hardening and lumps, or a fluid collection around the implant (seroma) which developed years after the implants were placed. It appears the condition may develop in the scar tissue around the implant or a fluid accumulation that occurs and resolves by simply removing the implant, scar tissue and fluid.
ROUTINE FOLLOW UP
The FDA and the ASPS (American Society of Plastic Surgeons) are recommending that women with breast implants continue normal medical follow up including self exam and mammography when appropriate. Women with silicone gel implants should have periodic MRI’s to evaluate for possible gel leakage every 2-3 years. Patients should be aware of changes to their breast such as swelling, pain or a lump and contact a board certified Plastic Surgeon for evaluation if these or any other changes occur to their breast.
IMPLANTS STILL AVAILABLE
The FDA reaffirmed that implants are still available to the public and are safe and effective devices. Breast implants are one of the most extensively studied of all medical devices because of the “silicone scare” of the 1990’s. The FDA did extensive research including clinical studies which I participated in to see the effects of silicone gel on the body. They concluded there was no correlation between silicone gel implants and connective tissue diseases (i.e. Rheumatoid or Lupus), cancer (breast, brain, respiratory, cervical, vulvar), neurologic disease, suicide or untoward effects on children from breast feeding.
Stay tuned for more information as it comes available and be sure to use a reputable resource such as a board certified plastic surgeon for your reference. Plastic surgeons have been looking at alternatives to breast implants for years such as using patients own fat for tissue transfer precluding the need for implants at all. See my blog on Fat Grafting to the breast.