Science, Scandals, and Patient Safety
A quiet revolution in the operating room is reshaping the future of breast augmentation.
Once hailed as a technological breakthrough for their ability to stay in place and reduce scar tissue, textured breast implants are now at the center of a global health crisis. The discovery of a rare cancer linked to these devices has triggered worldwide recalls, ignited thousands of lawsuits, and forced a dramatic rethinking of cosmetic surgery safety. This is the story of how a medical device designed to improve lives now has patients and surgeons questioning the very foundations of implant technology.
To understand the textured implant crisis, we must first look at what made them different. All breast implants have a silicone outer shell, but their surfaces vary significantly:
Move freely within the breast pocket, often feeling more natural as they respond to gravity 4 .
Feature a rough, irregular surface designed to adhere to tissue, preventing rotation and displacement—particularly important for teardrop-shaped anatomical implants 4 .
The fundamental problem emerged when clinicians noticed a pattern: the very texture designed to stabilize implants was associated with the development of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare type of non-Hodgkin's lymphoma that forms in the scar tissue and fluid surrounding the implant 3 5 .
BIA-ALCL is not breast cancer but a cancer of the immune system. Research eventually revealed that the rough surface of textured implants, particularly certain types, could trigger chronic inflammation that might lead to this lymphoma over time 3 . The risk was found to be highest with Allergan's Biocell textured implants, which featured an aggressive, highly textured surface 3 .
| Surface Type | Key Characteristics | Primary Benefits | Key Risks |
|---|---|---|---|
| Smooth | Moves freely in breast pocket | Natural feel and movement 4 | Higher rate of capsular contracture in some studies 4 , more rippling 8 |
| Microtextured/Nanotextured | Minimal surface texture | Reduced capsular contracture risk 1 , lower BIA-ALCL risk than textured 1 | Still being studied for long-term safety |
| Textured | Rough, irregular surface | Reduces rotation and displacement 4 | Significantly associated with BIA-ALCL 3 5 |
As the global medical community grappled with the emerging BIA-ALCL crisis, researchers in South Korea found themselves investigating not one but two simultaneous breast implant scandals. A recent 2025 observational study provides compelling evidence about the safety profiles of different implant types available in the post-crisis landscape 1 .
The Korean study examined 801 women who received implant-based augmentation mammoplasty for aesthetic purposes between November 2020 and October 2022. This timeframe is significant as it follows both the BIA-ALCL crisis and what researchers term "the first Korean case of a medical device fraud" involving another manufacturer 1 .
The study compared short-term safety outcomes across multiple commercially available microtextured devices, with particular focus on two key complications: capsular contracture (hardening of tissue around the implant) and implant rupture 1 .
The findings revealed striking differences between implant brands. Capsular contracture rates varied dramatically, from a low of 1.79% in Motiva Ergonomix implants to 10.53% in Eurosilicone Round Collection devices 1 .
Similarly, the study measured "capsular contracture-free survival"—how long implants remained free of this complication—and found significant variations between brands 1 .
Perhaps most notably, the research identified clear safety differences between surface technologies, with modern microtextured implants showing generally better safety profiles than both older textured devices and some traditional smooth implants 1 .
| Implant Brand | Capsular Contracture Rate | Rupture Cases | Capsular Contracture-Free Survival (Days) |
|---|---|---|---|
| Motiva Ergonomix | 1.79% (3/168) | 0 | 708.899 ± 8.595 |
| Sebbin Sublimity | 3.64% (21/577) | 2 | 599.327 ± 6.607 |
| Sebbin Integrity | 8.11% (3/37) | 0 | 584.941 ± 22.965 |
| Eurosilicone Round Collection | 10.53% (2/19) | 0 | 572.492 ± 37.374 |
In July 2019, the U.S. Food and Drug Administration (FDA) requested that Allergan recall all its Biocell textured implants and tissue expanders from the market after finding that women with these implants were six times more likely to develop BIA-ALCL than those with other textured implants 3 . This decision followed similar actions by regulatory bodies in Europe, Canada, and Australia 3 .
The recall triggered a wave of litigation. As of October 2025, 1,465 lawsuits were pending in the federal multidistrict litigation consolidated in New Jersey 7 . These lawsuits allege that Allergan failed to adequately warn patients and surgeons about the cancer risk associated with its Biocell implants 3 7 .
The crisis has profoundly changed how surgeons approach breast augmentation. A UK study found that while 82.7% of surgeons still used textured implants, there was a significant shift toward smooth implants among high-volume surgeons 2 . The top factors influencing implant selection now include patient preference, cosmetic outcome, risk of capsular contracture, and BIA-ALCL possibility 2 .
Understanding the textured breast implant crisis requires familiarity with several key medical and scientific concepts:
A common complication where the scar tissue capsule that normally forms around an implant abnormally tightens and hardens, potentially causing pain and distorting breast shape 5 .
Manufacturing processes that create rough, irregular surfaces on implants to promote tissue adhesion and prevent movement 1 .
A surgical technique used in BIA-ALCL treatment where the entire implant and surrounding scar capsule are removed together to ensure complete removal of cancerous cells 5 .
| Risk Factors | Common Symptoms | Recommended Actions |
|---|---|---|
| Textured implants, particularly Allergan Biocell 3 | Persistent swelling or pain around implant 3 5 | Consultation with plastic surgeon |
| Longer duration of implant placement 5 | Fluid collection around implant (seroma) 3 | Physical examination and imaging |
| Lumps in breast or armpit 3 | Fluid aspiration and testing if symptomatic | |
| Unexplained breast asymmetry 5 | Implant removal with total capsulectomy if BIA-ALCL diagnosed |
The textured implant crisis has revealed broader issues in implant safety and regulation. Recent FDA reports have also documented rare cases of squamous cell carcinoma (SCC) and various lymphomas other than BIA-ALCL associated with breast implants 5 . Additionally, some patients report systemic symptoms often called "breast implant illness," including joint pain, fatigue, and brain fog 9 .
In 2021, the FDA strengthened breast implant safety requirements, including adding a black box warning—the agency's strongest warning—and mandating that physicians use a detailed checklist to ensure patients understand potential risks 9 .
Updated recommendations for implant surveillance, using ultrasound or MRI imaging starting five to six years after implantation and every two to three years thereafter 9 .
Development of new implant surfaces like Motiva's SmoothSilk nanotechnology, which aims to provide the benefits of texturing with reduced complication risks .
The textured breast implant crisis represents a pivotal moment in cosmetic and reconstructive surgery. It underscores the sobering reality that breast implants are not lifetime devices 9 and that all implants—regardless of type—carry some risks that patients must understand.
Perhaps the most significant outcome of this crisis is the renewed emphasis on informed decision-making. The mandatory checklist now required before implant surgery helps ensure patients understand both short-term benefits and long-term responsibilities, including the likelihood of future surgeries for implant replacement or complication management 9 .
As research continues and new technologies emerge, the lessons from the textured implant crisis remain clear: patient safety must transcend market demands, transparency is non-negotiable, and the pursuit of aesthetic improvement must always be balanced with a thorough understanding of potential consequences.
If you have breast implants and experience persistent swelling, pain, or other changes in your breasts, consult with your healthcare provider for proper evaluation. Stay informed by requesting your "medical device card" from your surgeon, which contains specific information about your implants 9 .