Complications
Breast Implant Rupture: Symptoms, Diagnosis, and Treatment
Breast implants are not considered lifetime devices, and the chance of complications increases over time.[1] Breast implant rupture, a tear in the implant shell, is one of these long-term issues. This article explains the two rupture types (intracapsular and extracapsular), silent rupture, how rupture is detected (ultrasound, MRI, mammography), the current U.S. FDA imaging schedule, published rupture rates, and surgical options after rupture. Every figure below comes from a source listed in the References.
1. Rupture Types
| Type | Description | Typical Management |
|---|---|---|
| Intracapsular Rupture | The shell is torn, but the silicone stays inside the fibrous capsule that the body forms around the implant. | No consensus on management. One textbook chapter advises planned (semi-elective) removal because silicone may later spread beyond the capsule and cause inflammation.[4] |
| Extracapsular Rupture | Silicone has spread beyond the capsule into the surrounding breast tissue. | More likely to cause symptoms. Removal of the implant and the free silicone is recommended.[4] |
Modern silicone gel is cross-linked and somewhat cohesive, so when the shell tears, the gel tends to stay within the capsule.[3] For this reason, silicone implant ruptures are more likely to be intracapsular than extracapsular.[4]
2. Symptoms
When rupture does cause symptoms, reported signs include:[3,4]
- A change in breast shape, or new asymmetry.
- Breast pain.
- A lump or palpable nodules.
- Firmness from capsular contracture.
- Palpable lymph nodes (described mainly with extracapsular rupture).
- An abnormal finding on a mammogram.
Many ruptures cause no symptoms at all (Silent Rupture), so a breast that looks and feels normal does not rule out rupture. Physical examination alone performs poorly: in one study summarized in a 2021 textbook chapter, examination had a sensitivity of 30% compared with MRI.[4]
Sudden, marked swelling is less typical of rupture. A 2019 consensus guideline notes that, as a general rule, implant ruptures do not increase the overall volume of a breast; a large fluid collection around an implant should be evaluated for other causes, including BIA-ALCL (see Section 7).[8]
3. Silent Rupture
Because the gel tends to stay inside the capsule, a ruptured silicone implant may cause no change the patient can notice.[3] Sources differ on how often this happens. A 2021 textbook chapter states that the majority of silicone implant ruptures are silent,[4] while the FDA 2011 review of the Allergan Core Study reported that most ruptures in that study were accompanied by symptoms, with up to 35% silent depending on the cohort.[2]
In a 2022 multicenter study, high-resolution ultrasound was used to screen 584 women whose silicone gel implants had been in place for 3 to 20 years and who had no known rupture. The author estimated that 10.6% of the women had a silent rupture, and the proportion rose with the length of time since implantation.[3] This is the basis for routine imaging surveillance.
Current U.S. FDA labeling recommendations for silicone gel implants (guidance issued September 29, 2020):[1]
- No symptoms: first ultrasound or MRI at 5 to 6 years after surgery.
- Then ultrasound or MRI every 2 to 3 years thereafter.
- Symptoms, or an uncertain ultrasound result, at any time: MRI is recommended.
The 2020 update replaced an earlier MRI-only screening recommendation and added ultrasound as an acceptable screening option for patients without symptoms.[1] Your surgeon may suggest a different imaging schedule based on your history.
4. Imaging Modalities
| Modality | Published Accuracy | Notes |
|---|---|---|
| MRI | Described as the most sensitive and specific test for implant rupture.[5] Reported sensitivity ranges from 58% to 100% and specificity from 43% to 100% across studies.[4] | Recommended by the FDA when symptoms are present or an ultrasound result is uncertain.[1] Cost is significant, and patients with claustrophobia or implanted metal devices such as pacemakers may be unable to undergo MRI.[4] |
| High-resolution Ultrasound | Reported sensitivity ranges from 41% to 74% and specificity from 57% to 92%. Accuracy is highly operator-dependent and falls when capsular contracture is present.[4] | Accepted by the FDA since 2020 as a screening option for patients without symptoms.[1] Low cost and can be performed in an office setting. In a 2022 study, rupture was confirmed at surgery in 30 of 40 women whose scans had been read as ruptured (75%).[3] |
| Mammography | Extracapsular rupture is readily seen; sensitivity for intracapsular rupture is low.[4] | Should not be used as the only test for implant rupture.[4] |
| CT | Not a routine rupture test. | May be an alternative when MRI cannot be performed; its use of ionizing radiation must be considered.[4] |
5. Manufacturer Rupture Data (General)
Reported rupture rates vary with the device, the indication (first augmentation or revision), whether patients were routinely screened with MRI, and above all the length of time the implants have been in place.[2,3] The figures below come from U.S. Core clinical studies. They describe study populations, not the risk for any individual patient:
- Mentor silicone gel, 3-year data (2006): rupture in the MRI cohort was 0.5% after primary augmentation and 7.7% after revision augmentation.[5]
- Mentor silicone gel, 8-year data (FDA 2011 review): cumulative incidence of rupture was 13.6% after primary augmentation and 15.5% after revision augmentation.[2]
- 10-year Core trial data (MRI cohort, primary augmentation): cumulative incidence of rupture was 24.2% for Mentor round gel implants; across the five U.S. device lines tabulated in a 2022 paper, figures ranged from 6.6% to 24.2%.[3]
- Motiva: published Motiva series are smaller and shorter than the U.S. Core studies. In one company-independent series of 100 women (200 Motiva Ergonomix round implants) operated on over 3 years and followed for at least 6 months, one ruptured implant was found during revision for implant displacement. The authors state that large-scale studies are needed to determine the actual rupture rate.[9]
Rupture risk rises with the time an implant has been in place.[2,3] Contributing factors described in the literature include shell fold flaw, manufacturing flaws, and technical errors during surgery.[5] A history of blunt chest trauma is not unusual in patients who present with rupture, but it often precedes the diagnosis by months to years, so its causal role is uncertain.[4]
6. Surgical Revision Options
The plan is made with the patient after discussing the risks, benefits, and alternatives of each option.[4] At UNE Plastic Surgery, replacement implants are round silicone gel implants (Motiva or Mentor), and surgery is performed under general anesthesia with an anesthesiologist on site.
Implant exchange
The ruptured implant and any free gel are removed, the capsule is assessed, and a new implant is placed if the patient wishes. When silicone has escaped the capsule, one textbook chapter suggests placing the new implant in a fresh (virgin) pocket to minimize cross-contamination.[4]
Capsulectomy
Indications for capsulectomy listed in a surgical textbook include a ruptured silicone implant, silicone granulomas, and a calcified or thick capsule.[5] After extracapsular rupture, removal of the implant and the escaped silicone (including granulomas) together with capsulectomy, with or without replacement, should be offered.[4] If BIA-ALCL is diagnosed, treatment centers on timely, complete surgical excision, including en bloc removal of the implant and capsule.[8]
Explant only
Some patients choose to remove implants without replacement.[3] Breast sagging that was present before explantation is rarely corrected without a formal lift (mastopexy). A lift can often be combined with capsulectomy and implant removal, but staging it about 3 months later is advised when soft-tissue coverage is sparse or ptosis is severe, and mastopexy is avoided in smokers.[6]
Same-stage adjustments
Patients presenting for explantation or exchange often benefit from simultaneous breast contouring during capsulectomy and implant exchange.[6] Other issues that are present, such as capsular contracture, malposition, asymmetry, double bubble, or bottoming out, can be assessed at the same consultation, and whether to combine corrections is decided case by case.
7. Does Rupture Cause Cancer?
Epidemiologic studies comparing women with and without implants have not shown an increased risk of breast cancer in women with implants.[7] The FDA 2011 review found that the Core Studies did not demonstrate an association between silicone gel implants and breast cancer, while noting that these studies were not designed to detect rare outcomes.[2] These data concern implants in general. For ruptured implants specifically, a 2021 chapter notes that it is not known whether the amount or duration of silicone exposure is related to later disease.[4]
A separate concern is BIA-ALCL (breast implant-associated anaplastic large cell lymphoma). It is a type of non-Hodgkin lymphoma, a cancer of the immune system,[1] and not a cancer of the breast tissue itself.[5] It occurs more commonly with textured than with smooth implants.[1] Its most common presentation is a large fluid collection around the implant, appearing at least 1 year and on average 7 to 10 years after placement of a textured implant.[8] An individual's risk is considered low, but the disease is serious and needs prompt treatment.[1]
8. When to Seek Evaluation
- A change in breast shape, new asymmetry, a new lump, or new firmness.[3,4]
- Breast pain that does not settle.[4]
- New swelling or a fluid collection months or years after surgery, which also needs evaluation for BIA-ALCL, especially with a textured implant history.[5,8]
- Imaging due under the FDA schedule: first ultrasound or MRI at 5 to 6 years, then every 2 to 3 years.[1]
- An uncertain ultrasound result or an abnormal mammogram.[1,3]
References
- U.S. Food and Drug Administration. Breast Implants: Certain Labeling Recommendations to Improve Patient Communication. Guidance for Industry and Food and Drug Administration Staff. Document issued September 29, 2020. https://www.fda.gov/media/131885/download
- U.S. Food and Drug Administration, Center for Devices and Radiological Health. FDA Update on the Safety of Silicone Gel-Filled Breast Implants. June 2011.
- Salzman MJ. Silent rupture of silicone gel breast implants: high-resolution ultrasound scans and surveys of 584 women. Plast Reconstr Surg. 2022;149:7-14. https://doi.org/10.1097/PRS.0000000000008632
- Ha AY, Grant DW, Tenenbaum MM, Myckatyn TM. Implant rupture: pathophysiology, diagnosis, and management. In: Kim JYS, ed. Managing Common and Uncommon Complications of Aesthetic Breast Surgery. Springer Nature Switzerland; 2021:45-52. https://doi.org/10.1007/978-3-030-57121-4_5
- Katzel EB, Parker TH III, Janis JE, Hammond DC. Breast augmentation. In: Janis JE, ed. Essentials of Aesthetic Surgery. New York: Thieme; 2018:723-750. ISBN 9781626236547.
- Lemmon J, Ramanadham SR, Grotting JC. Mastopexy. In: Janis JE, ed. Essentials of Aesthetic Surgery. New York: Thieme; 2018:751-762. ISBN 9781626236547.
- Handel N. Breast cancer diagnosis, prognosis, and treatment in augmented women. In: Spear SL, ed. Surgery of the Breast: Principles and Art. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2011:35-47.
- Clemens MW, et al. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J. 2019;39(Suppl 1):S3-S13. https://doi.org/10.1093/asj/sjy331
- Huemer GM, Wenny R, Aitzetmüller MM, Duscher D. Motiva Ergonomix Round SilkSurface silicone breast implants: outcome analysis of 100 primary breast augmentations over 3 years and technical considerations. Plast Reconstr Surg. 2018;141(6):831e-842e. https://doi.org/10.1097/PRS.0000000000004367
Medical disclaimer. This article is general information and does not constitute medical diagnosis or treatment advice. Results vary with individual tissue condition and body type; accurate diagnosis and surgical planning are determined through in-person consultation with a board-certified plastic surgeon.
Dr. Kim Uigeon (Board-certified plastic surgeon, Republic of Korea · UNE Plastic Surgery)