What’s New with Breast Augmentation in 2019?
Year after year, breast augmentation has remained one of the most popular cosmetic procedures for women in both the U.S. and worldwide— and that popularity only continues to grow. According to the American Society of Plastic Surgeons (ASPS), breast augmentation has been the top cosmetic procedure performed since 2006, with 313,000 women undergoing breast augmentation in 2018 (a four percent increase from the year before).
The ever-evolving landscape of breast augmentation techniques and implant device materials has provided patients with safer and less invasive augmentation options than ever before. However, despite these advancements, breast implants have once again fallen under heavy scrutiny in the last year as health officials around the globe continue to re-examine the safety of textured breast implants. Here’s everything you need to know about the latest news in breast augmentation and what it means for you.
BioCell Textured Implant Recall
On July 24, 2019, the global pharmaceutical company and breast implant manufacturer Allergen announced that it would be voluntarily recalling all unused stock of BioCell saline-filled and silicone-filled textured breast implants and tissue expanders from doctors’ offices and hospitals worldwide; as well as suspending all future sales of these products. This announcement came following the recently updated findings of global safety information provided by the U.S. Food and Drug Administration (FDA) concerning the correlation between these products and the risk of patients developing a rare form of cancer known as breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
According to the FDA’s findings, to date, there are 573 unique cases of BIA-ALCL that have been reported worldwide, with 33 of those cases ending in fatality. While the likelihood of developing BIA-ALCL is still thought to be a rare occurrence with less than .03 percent of patients with BioCell textured implants developing the disease, 84 percent of the 573 reported cases have been attributed to Allergan textured implants. In fact, the FDA has demonstrated that the risk of developing BIA-ALCL with Allergan BioCell textured implants is six times higher than the risk of BIA-ALCL with textured implants from other U.S. manufacturers.
Allergan had already pulled its textured implants from the market in Europe in December of 2018 after the National Agency of Medicines and Health Products (ANSM) in France ordered a recall and ban of the brand’s textured devices, which are more commonly used in Europe than North America. Following this, Allergan voluntarily issued a recall in Canada in May of 2019 after the country’s health agency suspended Allergan’s licenses for the implants due to their associated risks with the disease. However, as BioCell textured implants and expanders vanish from the market, it is unclear what the future holds for textured breast implants.
Textured Implants: Safe or Deadly?
Based on the available evidence, the sales of textured implants from other manufacturers will be allowed to continue in the U.S. as the FDA continues to evaluate whether the risk of developing BIA-ALCL is limited to specific models of breast implants like BioCell, or whether it applies to textured breast implants as a whole. Textured implants will continue to be produced and remain on the market worldwide with the exception of the brands banned in Europe. The ban in Europe covers macro-textured and polyurethane models of implants made by six different implant manufacturers, including Allergan.
Macro-textured and polyurethane are two categories of textured implants associated with higher risks of BIA-ALCL, but the differences between textured implant models and their associated risks with the disease can be dramatic. One forthcoming study found that Allergan Biocell textured implants, for example, pose a 16-times higher risk of ALCL than other textured brands on the market. Many medical professionals believe that the textured surface and higher surface area of these implants provide more opportunity for bacteria to lodge than smooth-shelled implants.
Despite the prevalence of BIA-ALCL in textured implants, there is an incredibly low risk of developing the disease. The FDA has advised that women with breast implants— including those with Allergen BioCell devices — do not need to have their implants removed unless they are experiencing symptoms of the illness. If you do sense any abnormalities within your breasts or notice any significant changes, you should immediately follow up with Dr. Man to receive a diagnosis. While the development of the disease is highly uncommon, it can be deadly if not diagnosed early and promptly treated.
What to Know About BIA-ALCL
Contrary to what you might think, BIA-ALCL is not breast cancer, but rather a form of non-Hodgkin’s lymphoma, or cancer of the immune system. In most cases, BIA-ALCL has been found in the scar tissue and fluid near the implant, though it can spread throughout the body. The symptoms of BIA-ALCL typically display as:
- Breast enlargement or hardening
- Lump in the breast or armpit
- Large fluid collection surrounding an implant
- Persistent pain
- Changes in breast shape and size
These symptoms of BIA-ALCL have been reported between six months and 26 years after implant placement, but are typically diagnosed an average of seven to nine years after implant insertion. Fortunately, BIA-ALCL is a highly treatable disease. In most cases, BIA-ALCL can be treated with a procedure that removes the implant and scar tissue surrounding the implant; however, some patients may require additional treatment with chemotherapy or radiation in more advanced cases of the disease.
Whether you are considering getting breast implants or already have them, you may have more questions regarding the recent updates in BIA-ALCL and what they mean for you. If you would like to learn more about breast augmentation, textured breast implants or BIA-ALCL, schedule a consultation with board-certified plastic surgeon Dr. Daniel Man today. Dr. Man prides himself on being at the forefront of the latest developments in breast implant safety to ensure his patients are fully educated on the potential benefits and risks of all breast implant styles. Contact the office of Daniel Man, M.D. at 561-395-5508 to stay informed about what’s new in breast augmentation.