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NCT Number: NCT04715802

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

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.

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Key information

Conditions

Breast Breast Reconstruction Mammaplasty

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, 310003, China

About this study

The primary purposes of this study are to:

  • Compare the safety and effectiveness of IBR vs DBR after PAAG removal;
  • Compare the safety and effectiveness of breast implants with silicone gel prosthesis vs autologous fat transplantation after PAAG removal;
  • Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type.

The secondary purposes of this study are to：

  • Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation;
  • 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.
  • Further refine the algorithm for breast reconstruction in patients with PAAG injections.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Breast-Q questionnaire

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.

Other names: Breast-Q questionnaire

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.

Other names: Breast-Q questionnaireBreast-Q questionnaire

Primary outcomes

  1. the occurrence of a postoperative complication

    Time frame: until 10 years post operation

    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.

  2. The probability of reoperations

    Time frame: until 10 years post operation

    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.

Secondary outcomes

  1. Patient-reported quality of life, QOL

    Time frame: until 1 year post operation

    Patient-reported quality of life using Breast-Q score to evaluate changes in breast appearance, mental health, physical health and sexual health satisfaction before and after surgery.

  2. Aesthetic evaluation

    Time frame: until 1 year post operation

    It was evaluated by the Aesthetic Items Scale, which was a standardized tool for evaluating the aesthetic effect of breast reconstruction surgery, which was first proposed by Visser and Brinkman. The specific method was as follows: 3 experienced plastic surgeons evaluate 5 standardized photos (front, oblique, and side) of the patient before and after surgery. All photos were organized into slides and displayed randomly, with other information hidden (Such as preoperative or postoperative state, reconstruction method used, complications or whether to perform a second operation, etc.). In order to minimize the deviation, blank slides were displayed between the photos, and the random order of the photos of each observer was different. Each doctor used a five-point Likert scale to score breast volume, shape, symmetry, scars, and nipple areola. In addition, each doctor gave an overall satisfaction score between 0-10 points based on pre- and post-operative photos.

  3. change in patient satisfaction

    Time frame: until 1 year post operation

    Patient satisfaction consisted of four structured questions that assessed satisfaction with the size, shape, symmetry, and sensitivity of the breast. Patients were asked to rate their final result as "good", "satisfactory", "poor" or "bad".

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2022
Study completion
2025
First posted
Jan 20, 2021
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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