Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel

NCT ID: NCT04715802

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-18
• Study Completion Date: 2025-12-31

Brief Summary

Since polyacrylamide hydrogel (PAAG) was used in cosmetic surgery in 1997, about 30 million women have received PAAG injection for breast augmentation. Although the use of PAAG has been prohibited in most countries due to its myriad complications, a large number of symptomatic patients and asymptomatic patients have continued to seek medical advice. The strategy of repairing secondary breast deformities after PAAG removal has increasingly become a concern for both doctors and patients, but there is no standardized algorithm yet. The purpose of the present study was to perform a retrospective study to compare the safety and effectiveness of different reconstruction timing and method after removing the gel.

Detailed Description

The primary purposes of this study are to:

1. Compare the safety and effectiveness of IBR vs DBR after PAAG removal;

2. Compare the safety and effectiveness of breast implants with silicone gel prosthesis vs autologous fat transplantation after PAAG removal;

3. Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type.

The secondary purposes of this study are to：

1. Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation;

2. Compare the rate of postoperative complications and reoperations between the patients who had breast reconstruction with implants and patients who had primary breast augmentation with implants.

3. Further refine the algorithm for breast reconstruction in patients with PAAG injections.

Conditions

Breast; Mammaplasty; Breast Reconstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

PAAG removal + Immediate implant reconstruction

Patients who had a one-stage operation comprising gel removal and immediate breast reconstruction.

Immediate breast reconstruction with implant

Intervention Type: PROCEDURE

Because most fillers are under the mammary gland, it is better to place the prosthesis into the opening under the pectoralis major muscle, which avoids contact between the prosthesis and the residual hydrogel to reduce the chance of infection. If postoperative complications disappear and imaging shows no filler remnants after more than 3-month follow-up, secondary breast augmentation can be planned. For placement of the prosthesis, the plane under the pectoralis major is preferred, which avoids prosthesis contact with the residual hydrogel to thus reduce the chance of infection.

PAAG removal + Delayed implant reconstruction

Patients who had a two-stage operation comprising gel removal and delayed breast reconstruction at least 3 months later. The first included maximal gel removal and purulent tissue debridement, if necessary. Thereafter, patients were invited for a clinical follow-up and discussion about DBR 3 months later. The latter was offered as a second stage in those opting for it.

delayed breast reconstruction with implant

Intervention Type: PROCEDURE

The first stage included maximal gel removal and purulent tissue debridement, if necessary. Thereafter, patients were invited for a clinical follow-up and discussion about DBR 3 months later. The latter was offered as a second stage in those opting for it.

PAAG removal + No breast reconstruction

Patients who only underwent surgical PAAG removal without breast reconstruction.

No interventions assigned to this group

PAAG removal + Delayed autologous fat grafting reconstruction

Patients who underwent a two-stage operation comprising surgical PAAG removal and autologous fat injection at least 3months later. Usually, the amount of transplanted fat was 150-200mL/side. A multilayer and multi-tunnel injection method was commonly used.

delayed breast reconstruction with autologous fat transplantation

Intervention Type: PROCEDURE

Because fat injection after PAAG removal has a high infection risk, it is recommended to be conducted after 3-6 months of follow-up. The advantage of autologous fat transplantation is its ability to repair a variety of breast shape deformities caused by PAAG removal. Fat injections may need to be repeated several times. The interval between injections should be at least 3 months. Usually, the amount of transplanted fat is 150-200 mL/side. A multilayer and multi-tunnel injection method is commonly used.

PAAG removal + breast reconstruction with implants

Patients who underwent surgical PAAG removal with immediate or delayed implant breast reconstruction.

No interventions assigned to this group

Primary breast augmentation with implants

Patients who had undergone conventional breast augmentation(BA) with implants during the study period who matched the study cohort by age(±5 years).

No interventions assigned to this group

Interventions

Immediate breast reconstruction with implant

Because most fillers are under the mammary gland, it is better to place the prosthesis into the opening under the pectoralis major muscle, which avoids contact between the prosthesis and the residual hydrogel to reduce the chance of infection. If postoperative complications disappear and imaging shows no filler remnants after more than 3-month follow-up, secondary breast augmentation can be planned. For placement of the prosthesis, the plane under the pectoralis major is preferred, which avoids prosthesis contact with the residual hydrogel to thus reduce the chance of infection.

Intervention Type: PROCEDURE

delayed breast reconstruction with implant

The first stage included maximal gel removal and purulent tissue debridement, if necessary. Thereafter, patients were invited for a clinical follow-up and discussion about DBR 3 months later. The latter was offered as a second stage in those opting for it.

Intervention Type: PROCEDURE

delayed breast reconstruction with autologous fat transplantation

Because fat injection after PAAG removal has a high infection risk, it is recommended to be conducted after 3-6 months of follow-up. The advantage of autologous fat transplantation is its ability to repair a variety of breast shape deformities caused by PAAG removal. Fat injections may need to be repeated several times. The interval between injections should be at least 3 months. Usually, the amount of transplanted fat is 150-200 mL/side. A multilayer and multi-tunnel injection method is commonly used.

Intervention Type: PROCEDURE

Other Intervention Names

Breast-Q questionnaire; Breast-Q questionnaire; Breast-Q questionnaireBreast-Q questionnaire

Eligibility Criteria

Inclusion Criteria

1. history of PAAG breast injection;

2. appeal to remove the gel;

3. availability of complete medical records;

4. accepting the potential complications of the operation and breast deformity after gel removal.

5. agreeing with medical history data collection, clinical follow-up investigation, and independent Complete the questionnaire.

Exclusion Criteria

1. Patients who had other breast diseases;

2. Patients who failed to follow the standard diagnosis, treatment and follow-up;

3. Lost to follow-up due to various reasons or incomplete medical records;

4. Patients with cognitive disorders such as mental illness, understanding, memory, or orientation, and other serious diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

IIT20200748A

Identifier Type: -

Identifier Source: org_study_id