Items get recalled all the time. We may receive notice from our car manufacturer that we need to visit a dealer to have a malfunctioning part replaced. Foods are sometimes recalled due to potential contamination. As often as recalls happen, they tend to feel far from home; they won’t actually affect us. For many women, the recent recall on BioCell textured breast implants by Allergan may hit a little too close to home.
We can understand how frightening it may feel to hear about a breast implant recall. Here, we want to discuss the details of recent events and how they may affect you.
What the Recall Involves
The FDA has requested a recall of only a small amount of breast implants. No devices with a smooth surface have been taken off the market. The exact medical devices that caused the FDA concern are:
- Saline-Filled breast implants
- Silicone-Filled breast implants
- Inspira Silicone-Filled breast implants
- 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- 133 Plus tissue expander
- 133 Plus tissue expander with suture tabs
All of these devices belong to the Natrelle line from Allergan. All are textured.
Why the Recall has been Requested
For the past several years, the FDA has been looking closely at the possible connection between breast implant associated anaplastic large cell lymphoma (BIA-ALCL). This condition may be triggered by the accumulation of fluid around the textured surface of the implant. The accumulation on its own is not a bad thing. In fact, it is quite common. What can happen in some cases, though, is that some of the cells contained in the fluid may become damaged and begin to grow abnormally, leading to the rare form of lymphoma.
Analyzing patient data entered into specific registries, the FDA confirmed that textured implants pose a greater risk for BIA-ALCL than smooth implants. Furthermore, out of the current 573 cases that have been reported worldwide, 481 of them involved Allergan BioCell devices. It is for this reason that the recall is limited only to these types of breast implants.
The FDA recall of Allergan BioCell textured implants does not mean that all women with textured implants, even those with BioCell implants, need to undergo implant removal (explantation). The FDA maintains that a revision surgery carries more risk than leaving implants in place unless symptoms have developed. The most common symptoms include swelling, pain, lumps, and asymmetry. Each of these relates to fluid accumulation around the implant.
Do Textured Implants Need to be Removed?
At first word of a recall, many women began questioning if they need to have textured breast implants removed, or even smooth implants, for that matter. The official answer is no.
Breast implant associated anaplastic large cell lymphoma shows clear signs if it does develop. Because fluid accumulates in the capsule around the implant, the development of abnormal cells is indicated by swelling and pain. If you are not having either of those symptoms, there is no need to rush to implant removal.
BIA-ALCL may occur at any point after textured breast implants are placed. It is important to stay up to date with mammograms and routine breast exams, both at home and with your doctor. Studies have indicated that this lymphoma can be successfully treated with implant and capsule removal. When abnormal cells are limited to the capsular tissue only, explantation may be the only necessary treatment. If cells have migrated to nearby lymph nodes, chemotherapy may be needed. Since the onset of BIA-ALCL correction, 93% of patients remain cancer-free three years after treatment.
We understand your concern about breast implants and breast health. Get the peace of mind you need by discussing your concerns with a board-certified plastic surgeon who has performed thousands of breast cases. To schedule a visit in our Reno office, call (775) 826-4477.