Many patients have been tuned into the news lately and have become concerned about the recent coverage about the FDA recall of textured implants due to an increased rate of Anaplastic large cell lymphoma (ALCL). Here at Acadia Women's Health we strive to provide the safest medical treatment options to our patients. We work extensively to research any known complications which may affect our patients. If you have had your breast implants performed at Acadia Women's Health we can assure you that they are not the textured variety being recalled.
How are we so sure?
The FDA first noticed a possible connection between breast implants and ALCL back in 2011 and told doctors and patients about potential risks. We came to the determination that the possibility of such a reaction outweighed the benefit gained from the texturing of the implant. Eight years later we cannot be more proud in that decision. The FDA issues a voluntary recall for the textured implants on July 24,2019 following an increase of 116 new cases of Breast Implant Associated-ALCL globally and 24 deaths since earlier this year (France, Canada and Australia have already taken similar action).
Although not too many people have reached out about the news, we wanted to make sure and get the information out to out patients right away so that you can rest assured that your implants are not affected. We know many of you have had your implants for many years and have most likely forgotten what kind or model they are. We wanted all our patients who had them placed in our office that there is no need to worry about this recall. Hopefully that news lets you rest a little easier tonight. If you want to read a little more about what is going on or you know someone who may be affected, continue reading to hear what everything is about.
The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The recall helps ensure that unused products are removed from suppliers and doctors’ offices.
BIA-ALCL is a rare and highly treatable type of lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. This is a cancer of the immune system, not a type of breast cancer. The current lifetime risk of BIA-ALCL is estimated to be 1:3817 - 1:30,000 women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. When caught early, BIA-ALCL is usually curable.Common symptoms include breast enlargement, pain, asymmetry, lump in the breast or armpit, overlying skin rash, hardening of the breast, or a large fluid collection typically developing at least more than one year after receiving an implant, and on average after 8 to 10 years. For any patient experiencing these or any symptoms, they should see their doctor for evaluation.BIA-ALCL has been found with both silicone and saline implants and both breast cancer reconstruction and cosmetic patients. To date, there are not any confirmed BIA-ALCL cases that involve only a smooth implant. BIA-ALCL patients seem to have an allergic reaction to textured devices over many years. Currently, it is not possible to test for who is at risk of this disease.
If you know you have textured implants from implanted by another doctor there is currently no need to panic. The FDA does not recommend people with the recalled breast implants get them removed unless symptoms arise. The most common symptoms are unexplained breast enlargement, asymmetry, fluid buildup or a lump in the breast or armpit, but may be rarely more subtle such as overlying skin rash, hardening of the breast. Women who develop these symptoms should come see us for further testing and to remove the implant and replace it with a smooth version.
