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

NCT04715802 | Active Not Recruiting

• 1 other identifier: IIT20200748A
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast; Mammaplasty; Breast Reconstruction

Keywords

polyacrylamide hydrogel (PAAG)

Outcome Measures

Primary Outcomes (2)

• the occurrence of a postoperative complication

  Complications are defined as any adverse postoperative events directly related to gel removal or breast reconstruction surgery that require further treatment. According to the patient's main complaint, physical examination, chest radiography, breast ultrasound, breast mammography or MRI, pathological biopsy and other methods to evaluate the complications. According to the degree of complications, they were further divided into: (1) Mild complications: conservative treatment without surgical treatment. (2) Severe complications: the incidence of complications requiring reoperations or implant removal/replacement operations.

  until 10 years post operation

• The probability of reoperations

  Reoperation was defined as a surgical event performed after PAAG removal alone or stage I and II reconstruction. An anticipated operation of delayed breast implantation in patients with two-stage surgery was not classified as reoperation.

  until 10 years post operation

Secondary Outcomes (3)

• Patient-reported quality of life, QOL

  until 1 year post operation

• Aesthetic evaluation

  until 1 year post operation

• change in patient satisfaction

  until 1 year post operation

Study Arms (6)

PAAG removal + Immediate implant reconstruction

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

Procedure: Immediate breast reconstruction with implant

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.

Procedure: delayed breast reconstruction with implant

PAAG removal + No breast reconstruction

Patients who only underwent surgical PAAG removal without breast reconstruction.

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.

Procedure: delayed breast reconstruction with autologous fat transplantation

PAAG removal + breast reconstruction with implants

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

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).

Interventions

Immediate breast reconstruction with implant 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.

Also known as: Breast-Q questionnaire

PAAG removal + Immediate implant reconstruction

delayed breast reconstruction with implant 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.

Also known as: Breast-Q questionnaire

PAAG removal + Delayed implant reconstruction

delayed breast reconstruction with autologous fat transplantation 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.

Also known as: Breast-Q questionnaireBreast-Q questionnaire

PAAG removal + Delayed autologous fat grafting reconstruction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were admitted to the Plastic Surgery Department of the First Affiliated Hospital of Zhejiang University School of Medicine with complications after receiving PAAG injection for breast augmentation.

You may qualify if:

• history of PAAG breast injection;
• appeal to remove the gel;
• availability of complete medical records;
• accepting the potential complications of the operation and breast deformity after gel removal.
• agreeing with medical history data collection, clinical follow-up investigation, and independent Complete the questionnaire.

You may not qualify if:

• Patients who had other breast diseases;
• Patients who failed to follow the standard diagnosis, treatment and follow-up;
• Lost to follow-up due to various reasons or incomplete medical records;
• Patients with cognitive disorders such as mental illness, understanding, memory, or orientation, and other serious diseases.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 20, 2021
• Study Start: October 18, 2006
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)