The Recall We Must Discuss
- Posted on: Sep 15 2019
Recalls are normal events that may occur in various sectors of business. Now and then, medical devices are involved in such instances. Recently, the FDA has requested the recall of certain types of breast implants. Because breast augmentation surgery has been a leading procedure for many years, this is a recall that we must discuss.
In our experience, we can see that even a very limited recall such as this may incite widespread concern. You may have implants that are the farthest thing from those that have been taken off the market, and yet you wonder if you should have your implants removed. First, we want to say that we support every woman’s decision to remove or keep her implants. Second, we want to say that peace of mind is the ultimate goal. To help you navigate your choices, we discuss the particulars about the recent breast
At a Glance
Details matter, so we’ll be short and to the point here:
- The implants that the FDA has become concerned about are BioCell textured implants by Allergan. These are saline and silicone models in the Natrelle line.
- Natrelle textured implants have been recalled due to a higher risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
- BIA-ALCL is not breast cancer. It is cancer that affects the immune system that, when caught early, is highly treatable.
Do Breast Implants Need to be Removed?
Research suggests that it is not necessary for every woman with textured breast implants to have these medical devices removed:
- BIA-ALCL occurs in approximately 10% of breast implant cases.
- More than 93% of BIA-ALCL cases have been successfully treated, with patients staying disease-free for years after treatment.
- BIA-ALCL offers clues! Symptoms of potential breast implant problems include pain and swelling. Patients should see their doctor if these symptoms occur, and also if they experience a mass in the breast, itching or a rash, or any other changes to one or both breasts.
- BIA-ALCL is diagnosed via a thorough consultation, examination, and testing such as a fluid sample from the breast capsule.
What is Breast Implant-Associated Anaplastic Large Cell Lymphoma?
BIA-ALCL is a type of lymphoma. Lymphoma cancers develop in the lymphocytes, cells that are a part of the immune system. Breast Implant-Associated Anaplastic Large Cell Lymphoma develops in the breast capsule, where fluid has accumulated around textured implants. In the early stages, cancerous cells remain localized in this fluid. The removal of breast implants and capsular tissue may successfully eliminate all cancer cells. If the lymph nodes have been affected, those that have developed cancerous cells may need to be removed. Additionally (or alternatively), chemotherapy may be needed to destroy abnormal cells.
Your peace of mind is important. If you have concerns about your breast implants, schedule a consultation and examination with us. Routine mammograms are also beneficial (and necessary) for accurate awareness of breast health. To speak with a friendly member of our staff, call (212) 508-0000.
Posted in: Breast Augmentation