NCT04715802

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

Options of Breast Reconstruction Timing and Method After Removing of Polyacrylamide Hydrogel: a Propensity Score-matched Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.
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.

Timeline

• Start date: 2006-10-18
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2021-01-20
• Last updated: 2025-05-14

Locations

1 site across 1 country: China