UPDATE – 7/31/2019
In follow-up to Allergan’s voluntary recall of unused BIOCELL® textured products, the BIOCELL® Replacement Warranty program has been created. This program will run for the next 24 months expiring on 7/24/2021.
While the FDA has not recommended the removal or replacement of these implants, this program will provide un-textured (smooth) breast implants if a patient wishes to have their current Allergan textured implants replaced.
Although Allergan is providing the smooth implants at no cost, there will be fees associated with the surgery that will be the responsibility of the patient.
We are here to help you. Please contact our office with any questions or concerns at [email protected] or 303.278.2600
Andrew Wolfe, M.D., Steven Vath, M.D., Paul Steinwald, M.D., and the CCS Staff.
May 2, 2019
While breast implants have been studied for more than two decades and very rarely produce side effects, there is an uncommon condition called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
History
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL). At that time, the FDA knew of so few cases of ALCL that it was not possible to determine what factors increased a patient’s risk.
Over time, we have strengthened our understanding of this condition. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data.
In March 2019, the FDA held a two-day hearing on the long-term safety of textured breast implants, and released their findings in April 2019. At this time, the FDA maintains that breast implants are safe devices and does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.
At this time, this condition has only been documented thus far in textured implants and is very treatable when caught early.
What to Look For
Symptoms of the condition may include swelling, redness, changes in firmness or lumps around one or both implant(s). If you are experiencing these or any other symptoms, please contact us for an appointment. In the vast majority of patients, these symptoms are not serious and may or may not require treatment.
Our Current Recommendations Are:
Generally, it is a good idea to follow up with your plastic surgeon periodically to ensure that your implants are still intact and not producing any unwanted side effects. Mammograms will not detect these changes, only MRIs will, so we urge you to follow up with us periodically if you notice any of the above-listed side effects or are experiencing any other symptoms or discomfort.
If treated early, BIA-ALCL is almost always completely curable, but if untreated, it can be more serious. Although the incidence of BIA-ALCL is rare, we understand your concern. If you have any additional questions or concerns, please contact our practice by phone at (303)278-2600 or email [email protected].
We will continue to keep you informed of any new developments around BIA-ALCL.
Click here to read the FDA’s most recent article on BIA-ALCL.
Cordially,
Dr. Andrew Wolfe, Dr. Steven Vath, and Dr. Paul Steinwald
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