ALCL Updates and News 2022: Everything You Should Know About BIA-ALCL
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an exceedingly rare but severe condition that can arise in patients with breast implants. Patients need to understand the risks associated with breast implants, however remote, and how to identify warning signs of breast implant-associated conditions, like ALCL.
Learn everything you need to know about the risks and most recent information about BIA-ALCL. Discover the connectivity between certain types of breast implants and the development of health complications in patients. And see how the latest studies regard the efficacy of ALCL treatment for patients with breast implant-associated anaplastic large-cell lymphoma.
BIA-ALCL Updates and News – 2022
Breast augmentation is one of the most popular plastic surgery procedures in North America. Given the rising popularity of breast implants in recent years, more cases of BIA-ALCL have been diagnosed. Though still an exceedingly rare condition, the connection between breast implants and cases of ALCL has led to more studies and regulations regarding the materials and techniques used in breast augmentation procedures in 2022.
How common is BIA-ALCL?
Depending on which manufacturer the implant was made from, there is a wide range in incidence of BIA-ALCL ranging as high as 1 3,817 patients to as low 1 in 30,000. As of now, BIA-ALCL has mainly been linked to textured implants or in patients who have had previous textured implants or tissue expanders for a prolonged period of time. At Modern Surgical Arts of Denver, Dr. Dastoury or Dr. Zwiebel does NOT offer textured implants. Instead, Drs. Dastoury or Zwiebel and his medical staff will review options of saline vs. silicone implants in a smooth surface with patients who are a candidate for breast augmentation.
What is BIA-ALCL?
Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare T-cell lymphoma. In most of these cases, the cause of BIA-ALCL is connected to the textured material of the breast implant’s outer shell. Other factors that can increase your risk of developing BIA-ALCL include genetics, bacterial contaminants, and chronic inflammation. In most cases, onset of the disease process occurs after a mean of 8-10 years.
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What are the symptoms of BIA-ALCL ?
The symptoms of BIA-ALCL may involve intermittent swelling, presence of a mass or lump, generalized pain or discomfort in the area of the breast implant. These symptoms may be similar to symptoms of capsular contraction, but the main difference is the fact that in the progression of capsular contracture the size of the breast does not get bigger with fluid forming around the implant. Upon evaluation by your board certified surgeon, there will be evidence of fluid collection around the breast implant (seroma).
Though some of the symptoms may be related, Breast Implant Illness (BII) shows no known connection to the development of BIA-ALCL.
Textured implants have been connected to most cases of BIA-ALCL, leading to widespread recalls. The most highly problematic product linked to ALCL is the BIOCELL breast implants by Allergan Aesthetics. In 2019, the US Food and Drug Administration (FDA) convened a review panel to examine the connection between ALCL and breast implants. Further updates were given in 2020 https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated. In 2021, it announced new guidelines and regulations regarding product manufacturing and labeling.
2021 FDA Update on Breast Implants
In October 2021, the FDA issued changes to strengthen regulations regarding breast implants’ sales, distribution, and labeling. The changes serve three primary functions; the first is to provide patients with better information regarding known risks with breast implant products. The second change includes new guidelines to manufacturers for labeling their products, including:
- Boxed Warning
- Patient Decision Checklist
- Updated Rupture Screening Recommendations
- List of Specific Materials in Device
- Patient Device Card
During the process of implant selection our team at Modern Surgical Arts of Denver will review all of the above with you and give you ample amount of time to review the information pertaining to the medical device (breast implant) in order for you to make an informed decision about what you will be potentially putting into your body.
The third update issued by the FDA serves to inform the public about the status of post-approval studies related to breast implants and strengthen safety requirements for manufacturers.
How to Determine if Breast Implants are a Good Choice for You
Breast augmentation is growing in popularity, and the vast majority of patients’ experiences are overwhelmingly positive and without complications. You should fully consider the risks of any surgical procedure and talk to your doctor before making decisions that will permanently affect your body. Call our office and schedule your consultation with Drs. Dastoury or Zwiebel to learn about your risk for developing breast implant related ALCL.
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