What the FDA Recall Means
- Posted on: Sep 15 2019
Recalls have a way of becoming widely known. That is the whole purpose, after all, is to let the public know when there may be a risk to health or wellness. The FDA’s recent request that the use of certain textured breast implants stop may have sent unintended alarm to masses of women. At Chicago Breast Center, it is our duty and our honor to serve our patients in ways that best serve them. Transparency is one aspect of patient-centered care, which is why we want to discuss the details of the recent FDA recall with you here.
It is important to note that several breast implant devices remain on the market, completely available, and deemed safe by the FDA and thousands of treating physicians.
The fact that this recall has occurred does not mean that breast implants should be removed. Experts on this subject agree that it is riskier to undergo surgery to remove functional implants than to leave them in place.
Why Were Breast Implants Recalled?
The FDA has been monitoring the potential connection between textured breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) since 2011. Since that time, 573 cases have been reported globally. In looking at these cases, researchers found that 481 of these patients had some type of BioCell textured breast implant.
BioCell breast implants are made by Allergan for the Natrelle line of implant devices. Several models of saline, silicone, and highly-cohesive silicone anatomically shaped implants have been recalled. All are textured. Additionally, Natrelle 133 tissue expanders and tissue expanders with suture tabs have also been rescinded.
A Look at Breast Implant-Associated Anaplastic Large Cell Lymphoma
The reason the FDA recalled the breast implants mentioned is that the majority of cases of BIA-ALCL to date involve these devices. This cancer of the immune system is believed to originate in some of the cells that accumulate around the breast implant, where fluid can collect. These mutated cells can eventually travel to one or more lymph nodes, creating a more substantial concern.
According to studies, BIA-ALCL can be easily treated. More than 93% of women treated with breast implant removal (including the breast capsule) and, if necessary, chemotherapy, remained in remission three years after their appropriate therapy. This is an excellent prognosis and an outstanding reason to see a plastic surgeon right away if breast implants become symptomatic.
Potential symptoms of BIA-ALCL include breast swelling and pain. These do not confirm that cancerous cells have developed. An accurate diagnosis can only be achieved with specific tests.
Whether you have noticed changes in your breast implants or you want to gain peace of mind about yours, you are welcomed to schedule a visit in our Chicago office to consult with one of our experienced surgeons. Call 708-580-0144 to speak with a friendly member of our staff.
Posted in: Breast Implants