Allegan Textured Implant Recall
Allergan, the makers of the BIOCELL line of textured implants and tissue expanders, announced a worldwide recall of the line. The FDA requested Allergan to voluntarily recall textured implants and tissue expanders due to a link to a rare form of cancer, called BIA-ALCL, or “breast implant-associated anaplastic large cell lymphoma.”
What is BIA-ALCL?
BIA-ALCL is not a cancer of the breast tissue itself, but an immune system cancer that develops in the scar tissue surrounding the implant. It is very treatable when caught in the early stages. The textured implants, along with the scar tissue, is removed. The recall of these implants is a cautionary measure; the risk of developing BIA-ALCL remains very low.
Which breast implants were recalled?
The breast implants recalled are various styles, including textured implants from the Natrelle line, branded as “responsive,” “cohesive,” “soft touch,” and “highly cohesive anatomically shaped,” and “Inspira,” including:
- Natrelle silicone-filled textured breast implants
- Natrelle saline-filled textured breast implants
- Natrelle 133 Plus tissue expanders
- Natrelle 133 tissue expander with suture tabs
The recall does not include the Allergan Natrelle smooth or Microcell breast implants and tissue expanders – no link was found between smooth shell implants and BIA-ALCL. Textured implants are not often used in cosmetic breast surgery in the USA. However, if you are one of the five percent of women who have Allergan recalled implants, you may be concerned, and alarmed about the health risks. As BIA-ALCL is rare, the FDA advises if you have no symptoms of BIA-ALCL, there is no need to have your implants removed. However, this is a personal decision.
What do I do if I have the recalled textured implants?
After a breast augmentation, whether the implants were smooth or textured, it is always important to be alert to changes. While complications after breast augmentation are rare, early diagnosis is essential. The most common complication associated with breast augmentation is capsular contracture – the overdevelopment of scar tissue around an implant. BIA-ALCL is extremely rare, developing years after surgery, at an average of nine years, according to the FDA. If you have Allergan textured implants, the symptoms to watch for include:
- Capsular contracture
- Breast pain
- Mass or lump
- Seroma (a pocket of clear fluid developing around the implant)
- Swollen lymph nodes
- Rash, fever
If you have any symptoms, a test can be performed, which involves extracting fluid for evaluation. The FDA advises women to monitor their breasts and stay alert to any signs of BIA-ALCL. If symptoms appear, undergo testing.
Associates in Plastic Surgery: Your resource.
At Associates in Plastic Surgery in New Jersey, our team of board-certified plastic surgeons is a resource for women with concerns about developing BIA-ALCL. These implants are rarely placed in cosmetic our breast surgery. If you had implants placed by another surgeon, we believe you need accurate information. BIA-ALCL is so rare that your risk of developing this cancer is very low. A Dutch study revealed the estimated risks to be at 1 in 35,000 for women at age 50, 1 in 12,000 at age 70, and 1 in 7,000 at age 75.
Treatment for BIA-ALCL
If BIA-ALCL has developed, removing both the implant and the scar tissue around it, a procedure called “en bloc” surgery can be performed. When caught early, no other treatment (such as radiation or chemotherapy) is usually necessary.
Why does BIA-ALCL occur?
As yet, there is no definitive answer as to why BIA-ALCL develops. One theory is that the textured surface creates an environment that can harbor bacteria, or that the rough surface leads to an ongoing inflammation that could trigger the disease. The recalled BIOCELL Allergan implants have a “macro-textured” surface, developed to help keep the implant in place, common in teardrop-shaped implants, including styles from Allergan. Further research will be needed to determine exactly why some women develop BIA-ALCL. Until then, we advise you to merely stay alert to changes and get tested if you have symptoms or concerns.