'Capsular Contracture,' the most frequent adverse event of breast implant surgery that leads reoperation
Capsular contracture is the most common complication after breast implant surgery, where the capsule surrounding the breast implant thickens and hardens.1- Known as the most frequent side effect of breast implantation surgery, symptoms include changes in breast shape and pain. The incidence rate of capsular contracture ranges between approximately 10.6 to 17.5%.2,3 *Number varies according to literature
- Capsular contracture accounts for the biggest cause of breast implant removal and replacement surgery (25%~63%)(25%~63%).4,5
The physical and economic burden on the patient increases because reoperation is required.
Normal Capsule (LT) and Capsular Contracture(RT)6
(1) MFDS, 2015.11 (2) Arch Plast Surg 2015, 42, 532 (3) NEJM 1997, 336, 10 (4) Journal of Plastic, Reconstructive & Aesthetic Surgery, 2016, 69, 55-60 (5) Acta Biomater 2014, 10 (6) Journal of Surgical Research, Volume 280, December 2022, Pages 129-150
Unmet needs for safety remain as patients are still exposed to the risk of capsular contracture
- Textured (rough surface) type implants, a differentiated product from the existing smooth surface type, were developed to suppress capsular contracture. However, Breast Implant-Associates Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare type of cancer, was reported with the use of textured breast implants.
- As a result, the breast implant market has been restructured around smooth and micro/nano-textured products, however, unmet demand for safety still persists.
| Smooth Vs. Macro Textured | |
|---|---|
 |
|
| Surface Type | Advantages | Disadvantages | Surface Roughness | |
|---|---|---|---|---|
| Smooth | Natural movement, soft touch | Capsular Contracture |  |
< 10㎛ |
| Macro Textured | Capsular Contracture suppression (clinical evidence unclear) | BIA-ALCL |  |
< 50㎛ |
| Micro Textured | Soft touch, natural shape | Lacks clinical evidence due to short follow-up period *Lacks support on its inhibitory effect of Capsular Contracture, BIA-ALCL |
 |
10~50㎛ |
Global Breast Implant Surgery Market Status
- Breast implant surgery (including breast augmentation, etc.) is an operation conducted to reconstruct the breast for reasons such as ▲aesthetics, ▲mastectomy due to breast cancer, ▲loss of breast tissue due to trauma, and ▲insufficient development of breast tissue due to congenital deformity.1
- In 2020, the top-ranking cosmetic surgery performed worldwide was breast implant surgery, accounting for 16% of the total cosmetic surgeries performed (1,624,281 cases).2
- The breast implant surgery market is expected to grow from $2.6 billion in 2018 to $6.1 billion in 2030.3
(1) BS Research data (BSR IR 202206 v4) (2) ISAPA, Annual Report 2020 (3) Global Market Insights, Breast Implants Market Report, 2030, actual data 2017 to 2021, forecast period 2022 to 2030
Preparations for Simultaneous Entry into the Global Market Including North America
- BS Research is preparing to enter overseas markets, including North America with its biocompatible surface silicone gel-filled breast implant, starting with domestic marketing authorization.
- Has plans not only for entering the Korean market but also to enter North America, which holds the largest market, as well as other overseas markets including Europe and South America.
- North America, Europe, and South America, the major markets for breast implant surgeries, account for about 77% of the total market.
(1) Global Market Insights, Breast Implants Market Report, 2030, actual data 2017 to 2021, forecast period 2022 to 2030