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

Zhejiang University

Status: Active, not recruiting

Conditions: Breast Reconstruction; Breast; Mammaplasty

Treatments: Procedure: delayed breast reconstruction with implant; Procedure: Immediate breast reconstruction with implant; Procedure: delayed breast reconstruction with autologous fat transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT04715802

IIT20200748A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 6 patient groups

PAAG removal + Immediate implant reconstruction

Description:

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

Treatment:

Procedure: Immediate breast reconstruction with implant

PAAG removal + Delayed implant reconstruction

Description:

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.

Treatment:

Procedure: delayed breast reconstruction with implant

PAAG removal + No breast reconstruction

Description:

Patients who only underwent surgical PAAG removal without breast reconstruction.

PAAG removal + Delayed autologous fat grafting reconstruction

Description:

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.

Treatment:

Procedure: delayed breast reconstruction with autologous fat transplantation

PAAG removal + breast reconstruction with implants

Description:

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

Primary breast augmentation with implants

Description:

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