Breast augmentation has been one of the most popular cosmetic surgeries in the world, with just under 300,000 procedures performed in the United States in 2020 alone. The global market for breast implants is further segmented into product type and implant shape, including saline and silicone implants, and round or anatomical implants. However, concerns regarding silicone products, particularly textured implants, have affected the market dynamics significantly.
Silicone Breast Implant Safety Concerns and the Emergence of Structured Saline Implants
Silicone implants are a popular choice due to their natural feel and appearance, but they are more prone to silent ruptures than saline implants. Additionally, certain types of textured silicone implants have been associated with a rare form of lymphoma known as BIA-ALCL, with Allergan’s Biocell® textured breast implants speculated to be particularly linked to the disease. In July 2019, the FDA requested Allergan to recall specific models of its textured implants and tissue expanders from the market due to the risk of BIA-ALCL, leading to a worldwide recall of over 4 million breast implants and tissue expanders combined.
As of April 2022, the FDA received 1,130 U.S. and global medical device reports of BIA-ALCL, highlighting the importance of patient and physician awareness of potential risks associated with breast implants. One alternative option to textured implants is structured saline implants, which eliminate the risk of silent ruptures while maintaining the aesthetic appeal of silicone implants.
Regional Differences in Silicone Breast Implant Markets and Factors Affecting Cost and Demand.
The market breakdown between smooth and textured silicone implants varies significantly between North America and the rest of the world. The smooth implant segment dominates the silicone breast implant market in North America and Latin America, while the rest of the world is driven by textured silicone implants, particularly for anatomical implants that can only be sold as textured to prevent rotation. Costs for breast augmentation procedures vary depending on the density of plastic surgeons in the area, with lower costs in areas with more clinics. The growing incidence of cancer is also expected to reinforce market growth through patients seeking implants after a mastectomy.
In conclusion, the breast implant market is segmented by product type and implant shape, with silicone and saline implants and round or anatomical implants being the main options. Textured silicone implants have been linked to a rare form of lymphoma, leading to a worldwide recall of specific models. Patient and physician awareness of potential risks is crucial in ensuring the safe and effective use of implants. The market breakdown between smooth and textured silicone implants varies significantly between different regions, with costs also being affected by population density of plastic surgeons. As the demand for breast augmentation procedures continues to grow globally, it is essential to prioritize patient safety and satisfaction.
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- American Society of Plastic Surgeons. (2021). Textured Breast Implants and Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
- Food and Drug Administration. (2019). FDA requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
- Food and Drug Administration. (2022). Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). https://www.fda.gov/medical-devices/breast-implants/breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
- Tadisina, K. K., & Lee, M. R. (2021). Structured saline implants: An alternative to silicone implants. Plastic and Reconstructive Surgery Global Open, 9(5), e3565. https://doi.org/10.1097/gox.0000000000003565