In late July, the FDA requested that certain breast implants be taken off the market. Since that time, reputable plastic surgeons have stopped implanting specific textured breast implants and tissue expanders for cosmetic and reconstructive purposes. Also since that time, far too many women have been wondering about the safety of their breast implants. For that reason, we want to discuss the ripple-effect of the recent FDA breast implant recall and what it may mean for you.
Why Certain Breast Implants were Recalled
Breast augmentation using breast implants has had a long road. Early on, some women experienced adverse reactions to the silicone in certain implants. In response to that, manufacturers developed new kinds of silicone that would be more cohesive and much less likely to permeate tissue around the breast should a leak occur. Still, a problem occurred.
The reason the FDA requested the breast implant recall is that certain textured breast implants posed a greater risk for adverse reaction than others. Specifically, the breast implants models listed below presented six times the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) than other textured and nontextured breast implants. Those that were recalled all belong to Allergan’s Natrelle family and all are textured (this can’t be overstated in our opinion).
Which Breast Implants Were Recalled?
The list of implants that have been recalled include:
- Natrelle saline breast implants
- Natrelle silicone breast implants
- Inspira silicone breast implants
- 410 Highly Cohesive anatomically-shaped silicone breast implants
- 133 Plus tissue expander for breast reconstruction
- 133 Plus tissue expander with suture tabs
What Led to This Request?
As mentioned, the FDA deemed these implants a risk for BIA-ALCL. This condition can develop in some women in whom fluid accumulates around their implant. Fluid accumulation is not uncommon. However, in some cases, the cells within the fluid begin to grow abnormally, leading to a rare form of lymphoma. After forming a registry for women to report their diagnosis, the FDA discovered that 481 of 573 existing cases around the world involved the listed Natrelle breast implants.
What You Need to Do
We understand that any breast implant recall can be unnerving. The official stance of the FDA is that this recall does not indicate a need for women to remove asymptomatic breast implants. Instead, women are encouraged to maintain the recommended diagnostic imaging, mammograms and MRI screenings, as needed to observe the state of their implants on a routine basis.
If breast symptoms occur, a thorough consultation and examination can be performed to explore potential evidence of BIA-ALCL. These symptoms include pain, swelling, a rash, itching, or any other change in an augmented breast. It is important to also recognize that these symptoms do not confirm BIA-ALCL. Comprehensive diagnostics are performed to fully understand the cause before we attempt to make a diagnosis.
The team at Signature Plastic Surgery and Dermatology is here to help you navigate the breast implant process each step of the way. To consult with Dr. Shah about this surgical process, call 702.684.5502.