Breast Implant Safety: FDA Recall of Textured Implants in Virginia, Washington D.C. and Maryland.
As many of you may have heard, Allergan has recalled all of their textured implants and tissue expanders. They have been linked to a rare form of immune system cancer called Anaplastic Large Cell Lymphoma (ALCL). It is normal for patients in the Washington D.C. area and elsewhere to be concerned and may be considering removing their implants if they have Allergan type devices. I want to make sure you all understand the current situation and know fact from fiction.
This is NOT breast cancer. Implants are not associated with an increased risk of breast cancer. This was a theory back in the 90’s and it has been disproven since. Some believe breast implants cause other diseases like autoimmune disorders and again, none of that has ever had valid clinical evidence and never been proven to be true.
Anaplastic Large Cell Lymphoma (ALCL) is exceedingly rare. The first case was identified in 2011 and there have been 573 cases internationally documented to date. Millions of women have implants so this condition remains very rare! There are more cases of Anaplastic Large Cell Lymphoma (ALCL) in other countries than in the U.S.
This recall is only for Allergan textured implants. Textured implant devices from Mentor and Sientra are not involved. There was noted a 6 times higher risk of ALCL with Allergan’s Biocell texturing process as compared to the other company’s texturing process. Allergan smooth walled breast implant devices are not included in the recall. All smooth walled breast implant devices are considered safe.
The FDA is not currently recommending removal of all Allergan textured implants. They are recommending routine surveillance with annual mammography and monthly self breast exams. It is only if symptoms occur should removal be considered. Symptoms are typically one sided swelling with mild discomfort. These symptoms are noted many years after the implants are placed.
Treatment of ALCL is with implant and capsule removal. No other treatments are required for management.
Despite the science and the evidence there will be many women and their loved ones who for their own comfort and peace of mind will want to remove and exchange their Allergan textured implants for smooth implants. Allergan most likely will offer free smooth breast implants to those patients but there will be additional surgeon and hospital charges and fees for the exchange. Again the FDA has not called for removal and exchange but it is up to each person if they want to have their surgeon remove and replace the implants.
As the breast and body specialist plastic surgeon of The Naderi Center, I am available for consultation with any patient regarding this matter and look forward to helping women through this dilemma. Please contact Allergan and get information regarding your implant type to be sure which type of breast implant you have.
I hope this helps to clarify the current situation. I want you all to understand what is going on since there is lots of speculation and misinformation online and on chat forums. Please ask me any question during your consultation