About 300,000 patients have undergone polyacrylamide hydrogel injection breast augmentation in China. Over time, some patients may experience breast discomfort, including pain, hard nodules, displaced injections, and severe breast deformation. As a result, there is a steady stream of patients who seek surgery to remove the injections or to have their breasts reconstructed. Ensuring complete removal of the polyacrylamide hydrogel while maintaining the best possible breast shape is a major challenge for plastic surgeons during reoperation. In recent years, decellularized allograft dermis has been reported as an emerging biomaterial for breast reconstruction, and more satisfactory clinical results have been achieved. In this study, we attempted to combine the application of decellularized allogeneic dermis with silicone gel prosthesis for breast reconstruction after polyacrylamide hydrogel injection breast augmentation and evaluated its early complications.
1. clinical data.
Between 2008-1 and 2010-5, a total of 10 patients underwent breast injection removal and applied decellularized allogeneic dermis combined with silicone gel prosthesis implant for breast contour repair in our hospital. Four of these patients underwent simultaneous removal of the polyacrylamide hydrogel from the breast and implantation of decellularized allograft dermis combined with silicone gel implants, while six patients underwent second-stage removal of the polyacrylamide hydrogel from the breast and implantation of decellularized allograft dermis combined with silicone gel implants. The patients’ ages ranged from 22 to 41 years (average 33 years), and the injection time ranged from 3 to 10 years (average 6 years). The interval between the second stage of surgery after breast polyacrylamide hydrogel removal ranged from 6 to 36 months (mean 20 months). The surgery was performed using a subareolar semicircular incision in 9 cases and an inframammary fold incision in 1 case. All cases were implanted with Magenta round silicone gel breast implants, including MLP 230G implants in 7 cases and MLP 260G implants in 3 cases according to individual patient differences, and the application area of decellularized allograft dermis was 10cm*10cm/side in 2 cases and 12cm*12cm/side in 8 cases. The level of silicone gel prosthesis implantation was all in the deep layer of the pectoralis major muscle.
2.Treatment method
(1) Indication selection.
(1) Patients whose breasts have received polyacrylamide hydrogel injections for breast augmentation and have different degrees of subjective symptoms (pain, discomfort) and objective signs (hard nodes, breast deformation, etc.).
②Patients whose preoperative ultrasound or MRI evaluated the dose of injections exceeding 150 ml and whose breast shape may be affected after complete removal of the injections.
③Patients with high requirements for breast shape and strong demands for implantation
(iv) Those in whom part of the injections are distributed outside the anatomical region of the breast and where displacement of the implant alone may occur.
(2) Surgical method.
Determine the surgical method after full communication with the patient before surgery and sign the informed consent form. The patient’s body type and the basal diameter of the breast are used to select the appropriate silicone gel prosthesis and the appropriate size of the whole decellularized allograft dermis for intraoperative implantation.
At the same time, augmentation of the breast with silicone gel implants is performed: the skin is incised through a semicircular incision under the areola or an incision in the inferior crease, and the gland is separated along the superficial layer of the gland to the lower edge of the gland, and the lower edge is lifted off to enter the cavity where the injection is located. The injected material is thoroughly removed, along with the eroded pectoralis major and mammary gland tissue, and the cavity is flushed with large amounts of saline until the cleaning solution is clear, and the muscle is freed by entering along the lateral edge of the pectoralis major and cutting off the starting point below the muscle. The glandular and muscle defects were probed and evaluated, and the decellularized allograft dermis was cut to the desired area. A 4-0 absorbable suture is first applied to secure the decellularized allograft dermis to the tissue in the deeper aspect of the inframammary and lateral folds, thus defining the lower pole of the breast. The silicone gel implant is then inserted and the upper edge of the decellularized allograft dermis is sutured to the residual pectoralis major muscle break or to the break in the lower pole of the gland, leaving the residual pectoralis major muscle, glandular tissue and decellularized allograft dermis as a whole over the silicone gel implant. One drainage tube is placed in the cavity of the prosthesis and the incision is closed.
In the second stage, the decellularized allograft dermis combined with silicone gel implantation is performed: incision is made along the original incision to enter the cavity where the original polyacrylamide hydrogel is located, the degenerated muscle fibers and residual polyacrylamide hydrogel are removed, the adhesions between the gland and the muscle are fully released, the contracted scar in the inframammary fold is separated, the starting point of the pectoralis major muscle is cut off and freed from the deep layer of the muscle, the decellularized allograft dermis is attached to the The upper edge of the decellularized allograft dermis is sutured to the lower edge of the pectoralis major muscle with 4-0 absorbable thread, and the silicone gel breast implant is inserted into the posterior cavity of the pectoralis major muscle and the decellularized allograft dermis, and finally the silicone gel implant is isolated from the subcutaneous tissue and the residual glandular tissue is laid flat on top of the decellularized allograft on top of the dermis. One drainage tube was left in place to close the incision.
Typical case 1.
Patient, female, 40 years old, 5 years after injectable breast augmentation, developed hard nodules and lumps with pain in her breasts and requested removal of the intra-breast injected polyacrylamide hydrogel and maintenance of the breast augmentation form. During the operation, the injected material was completely removed from the breast and the MLP260G silicone gel implant was inserted at the same time. The lower edge of the silicone gel implant was wrapped with decellularized allograft dermis extending the pectoralis major muscle to increase the thickness of the soft tissue under the breast. Before the surgery and one month after the surgery, the breast shape remained full and round, with natural appearance, disappearance of hard lumps and soft feel, avoiding the deformity of breast collapse and atrophy caused by the removal of polyacrylamide hydrogel.
Typical case 2
The patient was a 32-year-old female, 2 years after the removal of polyacrylamide hydrogel from her breasts. She was dissatisfied with the atrophy and flattening of her breasts after surgery, which affected her aesthetic appearance. After admission to the hospital, the preoperative examination was completed, and the MLP230G silicone gel prosthesis was implanted, and the defect at the inferior border of the pectoralis major muscle was repaired with decellularized allograft dermis, wrapping the lower pole of the silicone gel prosthesis. Postoperative. No infection, fluid accumulation, displacement of the prosthesis, or contracture of the envelope were observed at 1 year of follow-up, and the breasts were plump and round, with natural shape and soft feel.
3. Results.
The postoperative follow-up ranged from 2 to 12 months, with an average of 6 months. The postoperative breast morphology was significantly improved in all 10 patients, and there were no adverse reactions such as infection, envelope contracture, rejection, implant expulsion and displacement, etc. The local discomfort symptoms such as pain and hard nodes before surgery were significantly relieved, and the shape was full and the lower pole was rounded and soft, and the patients all expressed satisfaction.
4. Discussion.
Because of the potential toxic side effects of polyacrylamide hydrogel on tissues, China has explicitly prohibited the intra-human injection of such materials. For some patients with obvious symptoms and signs, surgical removal of the injected hydrogel components is a feasible treatment measure. However, surgical removal of the injected material may also cause new damage to the breast and the formation of new deformities. According to the literature, secondary breast deformities after polyacrylamide hydrogel removal include breast collapse, deformation, local adhesions and nipple depression. Due to the gravitational effect, polyacrylamide hydrogel erodes more on the lower pole of the breast gland, and after surgical removal of the injected material, the lower pole of the breast is usually seen to be thin, which seriously affects the shape and shape of the breast. Therefore, depression of the lower pole of the breast is the most common deformity after breast injection removal, and usually the more thoroughly the injection is removed, the more pronounced the breast deformation will be. Since polyacrylamide hydrogel removal surgery has a decongestive effect on the breast, this type of surgery is actually somewhat disfiguring. Silicone gel breast implants can be used to fill the breast volume and improve the appearance of collapsed breasts, and are an effective means of addressing post-operative polyacrylamide hydrogel breast deformities.
Implantation of silicone gel breast implants usually requires adequate soft tissue coverage on their surface to minimize postoperative complications. In patients with injected polyacrylamide hydrogel breast implants, due to the tissue erosion capacity of the injected material, the injection removal procedure may remove the glands and subcutaneous tissues along with the visible lesions, which will somewhat reduce the thickness of the soft tissue covered by the implant. Placing a silicone gel implant in the posterior level of the pectoralis major muscle can increase the thickness of the surface tissue covered by the implant and improve the surgical result. However, the polyacrylamide gel component can also penetrate deeply into the pectoralis muscle, causing hyaline-like degeneration of the muscle component. Removal of the muscle component where lesions are evident increases the risk of crease formation and edge accessibility of the silicone gel implant to some extent. Furthermore, due to regression of the surviving pectoralis major muscle component, a step-like deformity may form on the surface of the prosthesis, which not only exacerbates the reduction of muscle coverage on the surface of the prosthesis, but also predisposes to a significant step-like deformity.
The formation of a continuous, evenly tensioned soft tissue coverage on the surface of the implanted prosthesis can effectively solve the above clinical problems. Traditional techniques advocate the application of autologous tissue flap techniques to repair various deformities due to soft tissue defects in the breast region. The anterior serratus flap and latissimus dorsi flap are commonly used autologous tissue flaps in mammaplasty surgery; they usually yield good aesthetic results, but the drawbacks are also obvious; in addition to adding additional scarring and prolonged operative time, they also deprive the patient of some normal motor ability due to muscle excision.
Decellularized allogeneic dermis is a homogeneous biomaterial. It is a residual collagen scaffold after decellularization of the human dermis, which has a certain thickness and toughness and is not immunogenic. Baxter first introduced it into the field of breast surgery to correct various complications after breast augmentation, and obtained satisfactory clinical results. After several years of development, decellularized allograft dermis has been widely used in the field of breast reconstruction surgery to replace various autologous tissue flaps and achieve a similar replacement for the surface of the prosthesis. Compared with autologous tissue flaps, decellularized allograft dermis has the disadvantage of insufficient volume replacement, but it can fully achieve tension bridging between the pectoralis major muscle and the inframammary and lateral folds, which can greatly benefit the shape improvement after implantation of the prosthesis. In addition to this, it significantly reduces the risk of crease formation and easy access to the edges of the implant.
For patients receiving polyacrylamide hydrogel injections for breast augmentation, the uncertainty of the cavity of the injected material is an important factor in the outcome of the implant. Because of the fluidity of polyacrylamide hydrogel, many patients experience cavities that extend into the upper abdomen, lateral chest, and other areas. Correspondingly, the implanted prosthesis is prone to displacement. Because the hydrogel-eroded tissue is usually less prone to adhesion, relying on sutures alone to close the cavity and adjust the breast crease is not a reliable outcome. In contrast, suturing the decellularized allograft dermis to the deeper tissues of the inframammary and lateral folds can reliably confine the breast implant to the posterior cavity of the pectoralis muscle, solving the clinical problem of easy displacement of the breast implant.
Due to the better biocompatibility, the transfer of decellularized allograft dermis in vivo is generally better. According to animal experiments and clinical observations, the decellularized allograft dermis only provides a scaffolding role in the tissue repair process. Autologous fibroblasts will gradually grow into its microporous structure, collagen will be replaced, fibers will be rearranged, and the decellularized dermis will eventually be assimilated to form autologous collagen fiber tissue.
In this type of surgery, both the prosthesis and the decellularized allograft dermis are implanted in the patient’s body, creating conditions for bacterial growth, so strict asepsis is needed during the surgery and postoperative prevention of infection. Some experiences with the use of decellularized allograft dermis also suggest the need for a high degree of vigilance regarding the risks associated with infection. Strict intraoperative asepsis, thorough intraoperative irrigation and postoperative application of antibiotics were the routine infection prevention measures in this group of cases.
This study was limited by the small number of cases and the short follow-up period, so only a preliminary evaluation of the application of decellularized allograft dermis in combination with silicone gel prosthesis was made, which is also a shortcoming of this study. Although the results of animal experiments suggest that the long-term application of decellularized allograft dermis is effective in avoiding the formation of prosthetic contracture, an objective evaluation of its long-term effects and reciprocal effects still requires more cases and longer follow-up before a scientific evaluation can be made.
5, Conclusion.
Recessed breast deformities after polyacrylamide hydrogel removal can be effectively improved with silicone gel implants. The decellularized allograft dermal implantation technique can provide a reliable surface coverage for the implanted prosthesis and reshape the breast shape, which is a new breast reconstruction method with less damage, simple technique and easy to promote.