Chinese doctors reported in an international journal the case of a 53-year-old woman who had PAAG filler injected into her breasts 20 years earlier. PAAG does not dissolve easily, and its use was banned in China in 2006. Five years after the procedure, the filler was removed from one side but remained on the other, and later fluid began to leak and the skin broke down. After emergency surgery, a biopsy confirmed breast cancer. The researchers stated that a causal relationship cannot be established from this single case. However, such materials are known to cause chronic inflammation when they remain for a long time. The US FDA states that no injectable filler is approved for breast augmentation. Korea's Ministry of Food and Drug Safety advises against using cosmetic fillers in areas outside their approved indications.
Contents
The body first encloses whatever enters it
The body treats any object that enters it as foreign and forms a membrane around it. This membrane is the capsule. It happens to everyone and usually stays soft.
The case above involved a banned substance that remained for a long time and caused ongoing irritation. Approved implants are different, but the enclosing process still occurs.
When the enclosing capsule thickens, the breast hardens
When the capsule becomes tough and thick and squeezes the implant, the breast hardens and its shape changes. This is capsular contracture.
Its severity is graded in four stages, looking at both appearance and how firm it feels. Early on, it can only be noticed by pressing, so it is hard to tell apart from normal firmness. It occurs when bleeding or infection during surgery, or pooled blood, irritates the capsule.
A meta-analysis of 13 studies (5,440 patients) comparing capsular contracture by implant surface found less capsular contracture with textured than with smooth surfaces. This means that even the same capsule can thicken to different degrees depending on the surface.[1]
But some changes are unrelated to that reaction
From this, it may seem that every change after surgery is due to that reaction, but it is not.
Rippling, where fine wave-like wrinkles show on the upper breast, is a different matter. It is fine folds in the implant surface showing through thin tissue, so the thickness of the covering tissue matters most. It tends to show in slim bodies or after significant weight loss.
A review of rippling found it shows more the thinner the covering tissue is, and in addition to replacing the implant, reinforcing the cover with fat grafting or ADM is being discussed as treatment.[2]
Related readingWhy rippling becomes more visible after weight loss is covered in "Breast rippling: why does it show more after weight loss?" (Korean).
Related readingIf pain persists more than 100 days after surgery, the signs to check are covered in "Breast pain still there after 100 days? Why you shouldn't just endure it" (Korean).
How to tell the two changes apart
One arises inside the enclosure; the other shows through because the cover is thin.
| Item | Hardening | Visible ripples |
|---|---|---|
| Where it arises | The enclosing capsule | Shows through the cover |
| Why it arises | An excessive reaction | Thin covering tissue |
Don't delay a check if you notice these signs
The two changes are hard to tell apart by appearance alone and can occur together. Ultrasound is used to look at the capsule and implant.
If firmness suddenly worsens, or there is redness, warmth or discharge that won't stop, don't delay. The doctors in the case above also recommended a thorough examination if an old procedure site does not heal well. If changes are gradual, they can be checked at a regular check-up.
When the outline shows, rather than only replacing the implant, reinforcing the covering tissue is also considered. Adding your own fat to blend the edges is one such approach.
The materials themselves also differ. Some remain in the body as they are, while others aim to blend with the surrounding tissue over time. The material used in BiVOL is the latter.
It involves placing a finely divided collagen-based material derived from human dermis, creating spaces where your own cells and blood vessels can settle. It differs in nature from filling a shape the way an implant does and is closer to creating an environment where tissue can settle.
Breast implant complications: common myths and facts
| What many people think… | What the evidence shows |
|---|---|
| "With an approved implant, no capsule forms." | Regardless of approval, the body encloses any object that enters it. A capsule forms in everyone. |
| "Hardening and ripples are the same problem." | Hardening comes from the capsule; ripples come from the thickness of the covering tissue. |
| "Massage will soften a hard breast." | Once the capsule has thickened, it is hard to reverse by rubbing. |
When patients tell me their breasts have changed, I first ask, "Has it become firm, or can you see a pattern?" Firmness points to the capsule inside; a pattern points to the cover outside.
Chinese doctors reported in an international journal the case of a 53-year-old woman who had PAAG filler injected into her breasts 20 years earlier. PAAG does not dissolve easily, and its use was banned in China in 2006. Five years after the procedure, the filler was removed from one side but remained on the other, and later fluid began to leak and the skin broke down. After emergency surgery, a biopsy confirmed breast cancer.
🔬 Supporting research
Peer-reviewed international journal articles that support this article. Click a title to open the PubMed abstract.
- Gland surgery 2022 — meta-analysis, 13 studies · 5,440 patients A systematic review and meta-analysis of capsular contracture rate after breast augmentation with textured and smooth breast prostheses. Key finding: capsular contracture rate differs by implant surface In text [1] · PMID 35242678 · DOI
- Aesthetic plastic surgery 2018 — review of rippling causes and treatment Rippling Following Breast Augmentation or Reconstruction: Aetiology, Emerging Treatment Options and a Novel Classification of Severity. Key finding: tissue thickness is key; fat grafting and ADM discussed as new treatments In text [2] · PMID 29546437 · DOI
🎬 Watch — Dr. Park Seong-Soo · BongBong Plastic Surgery
Related videos from BongBong Plastic Surgery's official channel and Dr. Park Seong-Soo's channel. Videos are in Korean and play on YouTube.
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6:36 From capsular contracture to implant rupture: restoration solutions for each breast augmentation complication (Korean) Dr. Park's channel · 2026.05.14 -
0:59 BiVOL as a tailored solution to reduce worries about capsular contracture after breast augmentation (Korean) Dr. Park's channel · 2026.04.02 -
7:29 Touching Bounce implants: how breast implant types differ in feel (Korean) Dr. Park's channel · 2026.09.02
Frequently asked questions (FAQ)
If the implant is approved, does the enclosing process not happen?
No. Regardless of approval, the body encloses any object that enters it. Approval is a process that verifies the material; it does not eliminate this process.
Can hardening and visible ripples occur together?
Yes, they can appear together. If the covering tissue is thin, both tend to be noticeable.
Will massage soften the firmness?
Once the capsule has thickened, it is hard to reverse by rubbing. Stimulation can aggravate inflammation, so follow your medical team's guidance on timing and method. First, distinguish whether what has changed is firmness or wrinkling. If firmness came first, suspect the inner capsule; if wrinkling came first, suspect the covering thickness. Noting when the change began will speed up your consultation.
📖 References
Click a [number] in the text to jump to its source, and ↩ to return. Only papers whose title, journal and year were verified on PubMed are listed.
- ↩ Zhai P, Wu Y, Yang D, Ma W, Zhai Y, Xie H. A systematic review and meta-analysis of capsular contracture rate after breast augmentation with textured and smooth breast prostheses. Gland Surg. 2022;11(1):166-174.PMID 35242678 · DOI— meta-analysis, 13 studies · 5,440 patients — capsular contracture rate differs by implant surface
- ↩ Pantelides NM, Srinivasan JR. Rippling Following Breast Augmentation or Reconstruction: Aetiology, Emerging Treatment Options and a Novel Classification of Severity. Aesthetic Plast Surg. 2018;42(4):980-985.PMID 29546437 · DOI— review of rippling causes and treatment — tissue thickness is key; fat grafting and ADM discussed as new treatments
BongBong Plastic Surgery · Dr. Park Seong-Soo, Medical Director
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