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Correcting Poland Syndrome with a Custom-Made Silicone Implant: Contribution of Three-Dimensional Computer-Aided Design Reconstruction

Chavoin, Jean-Pierre, M.D.; Taizou, Mohcine, M.D.; Moreno, Benjamin; Leyx, Pierre; Grolleau, Jean-Louis, M.D.; Chaput, Benoit, M.D., Ph.D.

Plastic and Reconstructive Surgery: August 2018 - Volume 142 - Issue 2 - p 109e–119e
doi: 10.1097/PRS.0000000000004605
Breast: Original Articles
Press Release

Background: Poland syndrome is historically associated with hypoplasia of the pectoral major muscle and abnormalities of the upper limbs. The authors propose an innovative procedure for correcting Poland syndrome thoracic malformations using three-dimensional modeling. Moreover, the authors evaluated aesthetic improvement, satisfaction, and quality of life after reconstruction with computer-aided design customized silicone implants.

Methods: Since 1993, the authors have treated 129 patients for Poland syndrome. Before 2007, the implants were made from plaster molds; since 2007, they have been made using three-dimensional computer-aided design. Patient satisfaction was assessed using a standardized questionnaire, and quality of life was evaluated using the Medical Outcomes Study 36-Item Short-Form Health Survey.

Results: Lipofilling was performed in combination with computer-aided design in one-third of cases, and breast prostheses were required in 24 percent of cases. We found three exposed prostheses and two infections. Cosmetic results were excellent in more than 90 percent of cases, and more than 80 percent of patients were very satisfied or satisfied, with no significant difference between men and women (p = 0.382). The Medical Outcomes Study 36-Item Short-Form Health Survey scores revealed significant improvements in role emotional (p < 0.05), emotional well-being (p < 0.001), and social functioning (p < 0.001).

Conclusions: Correcting Poland syndrome using a computer-aided design silicone implant fulfilled aesthetic and psychological demands, and significant improvements were seen in quality of life. The technique is simple and reliable and yields high-quality results, and three-dimensional computer-aided design has optimized the authors’ reconstructions. Nevertheless, associated procedures and secondary corrections remain necessary to obtain optimal results.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Toulouse, France

From the Service de Chirurgie Plastique et Reconstructrice, CHU Toulouse Rangueil; and AnatomikModeling SAS.

Received for publication June 29, 2017; accepted February 12, 2018.

Dr. Chavoin and Dr. Taizou are co–first authors.

Disclosure: None of the authors has a financial interest in any of the products or devices mentioned in this article. Main author Pr. JP Chavoin is involved since 2015 in spreading scientific knowledge and training with “AnatomikModeling SAS” CAD custom-made implants. Benjamin Moreno is involved in “AnatomikModeling SAS” since 2015.

Supplemental digital content is available for this article. Direct URL citations appear in the text; simply type the URL address into any Web browser to access this content. Clickable links to the material are provided in the HTML text of this article on the Journal’s website (www.PRSJournal.com).

Benoit Chaput, M.D., Ph.D., Plastic and Reconstructive Surgery Unit, CHU Rangueil, 1 Avenue Jean Poulhès, Toulouse, France, benoitchaput31@gmail.com

Poland syndrome is associated with varying degrees of thoracic abnormalities and malformations of the upper limbs. The pathognomonic anomaly is agenesis of the sternocostal fibers of the pectoralis major.1 Breast asymmetry occurs frequently in women,2 but the rate of hand malformations varies widely.3 Poland syndrome is a rare malformation, as the incidence is estimated at only one in 30,000 births.4 There appears to be a male predominance (3:1), and the majority of studies attest to lateralization of Poland syndrome on the right side. The cause of the syndrome remains unknown but a vascular origin, as supported by Bavinck and Weaver,5 could explain the existence of associated syndromes (e.g., pectus excavatum, tuberous breasts).

The extent of breast and chest-wall deformities varies widely in Poland syndrome. This is because of the variable degree of association between atrophy and not only the muscular plane, but also the thoracic bone plane and cutaneous plane (including breast in women). Surgeons must master several techniques to treat all of these malformations. Thus, several authors have proposed decision algorithms, based on their experience (often with very good results), but implementation is sometimes difficult.2 , 6–8 However, a customized technique perfectly suited to the malformation can be used for the majority of patients. Therefore, in 2007, we developed an innovative computer-aided design procedure for thoracic implant reconstruction of patients with Poland syndrome using thin-section images made from computed tomographic scan.9 , 10 This minimally invasive procedure consists of placing permanent, custom-made, rubber silicone elastomer implants to fill defects caused by muscular agenesis and, sometimes, the associated thoracic deformation.

We have used three-dimensional computer-aided design silicone implants to correct pectus excavatum with good results in more than 400 patients.10–12 This technique is minimally invasive, rapid, and associated with very low morbidity. Asymmetries greater than 200 ml can be corrected during a single operation with very good accuracy, by compensating for the loss of muscle volume, and leave a discrete axillary scar. Nevertheless, custom-made silicone implants are complex to model and expensive; thus, few surgeons use such prostheses. Very few relevant articles have appeared regarding these implants, and those that have used a relatively small number of patients. In 1991, Marks et al. presented a series of eight patients with customized silicone implants covered directly by the latissimus dorsi and achieved satisfactory results in 50 percent of cases.13 In 2003, Foucras et al., in conjunction with our team, published a series of 10 patients with mixed results because the implants were prepared using plaster molds.2 In 2015, Majdak-Paredes et al. considered custom-made silicone implants very useful for moderate deformations.6 However, none of these authors used computer-aided design with three-dimensional computed tomographic data.

In this study, we objectively evaluated the aesthetic improvement and quality of life of Poland syndrome patients who underwent reconstruction with three-dimensional computer-aided design custom-made implants. We also compared the quality of the reconstruction in men and women, for whom reconstruction imperatives often differ. Patient demographics and symptoms are discussed, and the surgical technique is described. We evaluated satisfaction, cosmetic results, and quality of life using the questionnaire of Del Frari and Schwabegger14 and the Medical Outcomes Study 36-Item Short-Form Health Survey.15 To the best of our knowledge, no study has explored long-term satisfaction, cosmetic results, or quality of life in such patients.

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PATIENTS AND METHODS

Since 1993, we have treated 129 patients for Poland syndrome thoracic malformations in our plastic and reconstructive surgery unit (Toulouse, Rangueil, France). All available thoracic reconstruction techniques were explained to the patients both orally and in writing. From 1993 to 2007, we used plaster molds of the thorax to prepare silicone implants (n = 15). Since 2007, we have used preoperative three-dimensional volume-rendered computed tomographic scans to design implants for 68 patients.

All patients were adults, and a senior surgeon (J.P.C.) performed all operations. Clinical characteristics, surgical details, technical success of remodeling, and immediate and late postoperative complications were recorded. We used the classification of Foucras et al., described by our team in 2003, and added the type IV classification, corresponding to patients who were previously operated on.2 For this study, we recontacted by telephone, or arranged an in-person consultation, with patients who had undergone reconstruction with three-dimensional computer-aided design silicone implants (n = 68). Patient satisfaction was evaluated retrospectively using standardized questionnaires, and quality of life was assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey questionnaire.

The patients rated their postoperative appearance as “excellent,” “good,” or “failed” using the cosmetic evaluation questionnaire of Del Frari and Schwabegger. Patients also completed the general quality-of-life Medical Outcomes Study 36-Item Short-Form Health Survey questionnaire and a satisfaction questionnaire according to the postoperative appearance questionnaire of Davis and Weinstein.16

The study followed the ethical tenets of the Strengthening the Reporting of Observational Studies in Epidemiology statement17 and was approved by the Institutional Review Board of Toulouse University Hospital in 1992. All patients gave oral and written consent.

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Statistical Analysis

Categorical variables are expressed as proportions and were compared between groups using Fisher’s exact test. Continuous variables are expressed as means with ranges and were compared between groups using the Mann-Whitney U test. A two-sided value of p < 0.05 was considered significant. All statistical analyses were performed using BiostaTGV software (Jussieu, France).

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Manufacture of Custom Implants by Means of Computer-Aided Design

Four steps are required to prepare the implants:

  1. First, a computed tomographic scan is obtained, with 1- to 1.2-mm slice thickness, during which the patients have to keep the arms along the body to avoid misrepresentation of the opposite pectoralis major muscle.
  2. An experienced computer scientist prepares the three-dimensional computer-aided design model of the implants: the computer scientist can remodel the missing spaces between the deep plane (named “surgical plane”; e.g., rib cage, intercostal spaces) and the superficial normal plane (named “anatomical plane”) to virtually correct chest asymmetry and enhance breast positioning in women (AnatomikModeling SAS, Toulouse, France). The anatomical plane is calculated using three-dimensional vectors to design an aesthetically correct thoracic curve relative to a three-dimensional database of normal thoraxes.
  3. Implant prototypes are prepared from the three-dimensional models using three-dimensional machining as a subtractive process on a hard polyurethane bloc (AnatomikModeling).
  4. Molding of each prototype allows casting using a rubber silicone elastomer (NuSil Technology, Carpinteria, Calif.). The implant is made not with gel but with a solid rubber silicone that is highly flexible (Shore 20 AA), tear-resistant, and gas-sterilized. Such implants can be retained for the duration of the patient’s life when the result is good (Perouse-plastie and Sebbin, Boissy l’Aillerie, France).
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Surgical Technique

General anesthesia is applied to all patients in the supine position, with the arm perpendicular to the thorax. We routinely prescribe an intraoperative prophylactic antibiotic (2 g of intravenous cefazolin injected at the start the surgery) (Figs. 1 through 3). (See Video, Supplemental Digital Content 1, which demonstrates implant design by three-dimensional reconstruction and surgical procedure, available in the “Related Videos” section of the full-text article on PRSJournal.com or, for Ovid users, available at http://links.lww.com/PRS/C845.)

Fig. 1

Fig. 1

Fig. 2

Fig. 2

Fig. 3

Fig. 3

Video

Video

The prototype is placed on the thorax to ensure optimal positioning. We trace the perimeter of the implant, arm along the body, thereby defining the limits of implant placement. The lower pole is positioned using a computerized marker (distance between the interclavicular sternum and the caudal margin of the implant).

An axillary approach is made with an 8-cm “lazy-S” incision. Dissection is performed to the costal periosteum, sparing the serratus nerve. Dissection of the precostal space is performed first with scissors, then by hand, to complete undermining up to the traced limits. In case of resistant fibrous septa, long curved Mayo scissors can be used. Hemostasis is controlled but the procedure is not associated with significant bleeding because of the small size of the internal mammary perforating vessels. The implant is inserted easily along the axillary path, and folded in on itself. The semirigid consistency of the implant facilitates folding and easy insertion; however, the implant is also nondeformable and noncompressible. Correct orientation of the implant is verified by an axillary “button” mark added during manufacturing. No drains are used and closure is performed in two layers using resorbable sutures. A mildly compressive thoracic belt is applied. The dressing is not changed during the first week. The belt is worn continuously for 2 weeks. Most patients return to work after 2 weeks. Sports activities are to be stopped for 3 months. In case of seroma, punctures are performed at 2 days and 8 days postoperatively.

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RESULTS

The demographic data and operative characteristics of the 129 patients (69 men and 60 women; mean age, 26 years; range, 9 to 40 years) are listed in Table 1. The mean number of interventions was 1.82 (range, one to six), and type I malformation was the most common. The patients benefited from the application of different surgical procedures, including computer-aided design custom-made silicone implants (52.7 percent), lipofilling (42.6 percent), mammary prostheses (24.8 percent), custom-made silicone implants by plaster molds (11.6 percent), latissimus dorsi flap (3.1 percent), and thoracic remodeling surgery (0.7 percent).

Table 1

Table 1

Here, we were mainly interested in reconstructions using three-dimensional computer-aided design implants (Table 2). We have treated 68 patients consecutively with the three-dimensional computer-aided design silicone implant during the 2007 to 2017 period. The sex ratio was 2.09 and the mean follow-up was 52.4 months (range, 12 to 96 months). The mean operative time was 49 minutes (range, 40 to 78 minutes), and the mean length of hospital stay was 4.2 days (range, 2 to 8 days).

Table 2

Table 2

A complementary lipofilling procedure was carried out as a second step in 20.6 percent of the patients to optimize the results. Nine women (41 percent) received a breast implant, always performed in a second procedure to allow the computer-aided design implant’s fibrous pocket to form. We take care not to reopen the pocket of the first implant by careful placement of the breast implant, to avoid sliding and implant displacement.

Concerning three-dimensional computer-aided design implants, two postoperative hematomas (2.9 percent) that required reintervention were recorded as complications (Table 3). We experienced two infections following lipofilling procedures, which required washing and antibiotic administration without implant removal. The axillary location of the scar seemed to prevent wound dehiscence. Two patients requested removal of their prostheses, one because of pain and the other because of psychological difficulty in accepting the presence of a foreign body despite a good early result and complete information. In comparison, removal was required in three cases of long-term prosthesis exposure in the first plaster series (20 percent). Periprosthetic seromas were found in 20.6 percent of cases, and these required puncture before resolving spontaneously. No implant exhibited capsular contracture, and we noticed no rupture; however, there was one case of rotation in a secondary procedure.

Table 3

Table 3

To complete the questionnaires, we recontacted all patients who received three-dimensional computer-aided design silicone implants and obtained responses from 41 (13 women and 28 men); thus, 27 patients were lost to follow-up. As the reconstruction goals and expectations differ between men and women, we analyzed and compared these two computer-aided design implant reconstruction groups. Both men and women rated the cosmetic outcomes of the computer-aided design implants as “good” to “excellent” in more than 90 percent of cases. Nevertheless, women were aware of the prosthesis under the skin more frequently than men (69.2 percent versus 32.1 percent; p = 0.043) (Table 4). In both groups, some patients stated that they were aware of the prosthesis during physical effort or intense sporting activity.

Table 4

Table 4

Concerning global patient satisfaction, approximately 77 percent of the women and greater than 80 percent of the men were “satisfied” or “very satisfied” (scores of 4 and 5, respectively) with their reconstruction, without a significative difference between the two sexes (p = 0.382) (Table 5).

Table 5

Table 5

Quality of life, as assessed by the Medical Outcomes Study 36-Item Short-Form Health Survey, showed significant improvements in both social and emotional aspects (Table 6). The Medical Outcomes Study 36-Item Short-Form Health Survey scores revealed significant improvement in role emotional and emotional well-being in men (p = 0.001 and p < 0.001) and women, respectively (p = 0.014 and 0.001). Social functioning improved significantly in men but not women (p< 0.001 and p = 0.096, respectively). Pain (body pain) associated with the prosthesis was significant in both groups. All patients described discomfort during intense sporting activities, but without pain that was quantifiable on a visual analogue scale. Ultimately, general health tended to be improved in both the men and women, but the improvement was significant only for the male reconstructions (p < 0.001). Figures 4 through 6 present “good” and “very good” score results. [See Figure, Supplemental Digital Content 2, which shows (above) preoperative frontal and three-quarters views with computed tomographic scan reconstruction of a 33-year-old woman with Poland syndrome (type 1). (Below) Results at 3 months after correction with computer-aided design silicone implant, http://links.lww.com/PRS/C846.]

Table 6

Table 6

Fig. 4

Fig. 4

Fig. 5

Fig. 5

Fig. 6

Fig. 6

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DISCUSSION

Poland syndrome remains a complex malformed entity with various clinical presentations because of levels of atrophy (muscle, bone, skin, and breast). Many procedures have been proposed to correct the malformations. For some, the latissimus dorsi muscle flap remains the gold standard8 , 18 , 19 and is sometimes used in women with a breast prosthesis. Moreover, tissue expansion,2 transverse rectus abdominis flap,20 an omentum flap16 , 21 and thoracic remodeling surgery,22 alone or in combination, can be used. The use of perforator flaps has also been described, such as the free deep inferior epigastric perforator flap23 or pedicled thoracodorsal artery perforator flap.24 Nonetheless, some of these procedures have high morbidity, and case series are limited.

Fat-transfer techniques are highly assistive in minor malformation, resulting in significant improvement in patients, but in most deformations, the limits of this treatment are quickly exceeded.25 Moreover lipofilling has been used widely to allow additional corrective procedures or to prepare the tissue before placing a prosthesis and thus improve atrophy of the chest wall. We have been reluctant to practice this procedure near the mammary gland, but it seems well established and the neoplastic risk appears very low.26–29

Several classifications of Poland syndrome have been proposed. Some are descriptive, whereas others propose decision algorithms for selecting the best surgical procedure.2 , 6 , 8 , 18 However, no classification system appears to have been widely accepted. Because of the wide clinical variety of manifestations of Poland syndrome, it is very difficult to apply standardized management techniques. Thus, with a view toward simplification, we developed a standardized three-dimensional computer-aided design procedure for custom silicone prostheses.

Even in the presence of a rib or thoracic malformation, or an associated pectus excavatum, there is no evidence of cardiac or respiratory functional consequences of the thoracic malformations that occur in patients with Poland syndrome. Indeed, recent meta-analyses by Malek et al. and Guntheroth and Spiers on the pulmonary and cardiac consequences of the condition revealed no evidence of improvement after thoracic surgery to correct malformations.30 , 31 Thus, we developed a reconstruction procedure that prioritized cosmetic concerns.

It is necessary to be aware that an aesthetic result and perfect symmetry are extremely difficult to obtain in patients with Poland syndrome; this must be relayed to the patient from the outset. The technical and surgical requirements for reconstruction differ between men and women, and it seems that reconstruction with computer-aided design implants makes it possible to obtain satisfactory results in both sexes. Nevertheless, women often require implantation of a breast prosthesis; 41 percent of the cases in our series showed frequent mammary hypoplasia.

Our initial implant preparation technique using an external plaster mold yielded good results; however, barely detectable imperfections in terms of contour or volume were occasionally evident. This was attributable to the interposition of soft tissues, such as breasts in female patients or well-developed muscles in male patients, in an effort to camouflage the deformation, with occasionally asymmetric results. These tissues varied in thickness and location, which compromised the plaster molding. In addition, the implant was more likely to be visible or detectable by touch when the skin was thin but three-dimensional computer-aided design allowed for rendering of a more optimized prosthetic design. With three-dimensional computer-aided design, the contours of the implant were softened, and the volume was always underestimated by 15 to 20 percent to avoid the maximum contour when the skin was thin.

We experienced only two hematomas and two infections, secondary to lipofilling, as complications. The hematomas required reoperation, and the infections necessitated removal of the prosthesis and cessation of antibiotic treatment. Seromas formed in 20.6 percent of cases during the early postoperative period and were the most frequently observed minor complication. These seromas were treated with one or two aspirations during the first postoperative month but always resorbed. No patient developed a residual seroma after 3 months. Patients should be told to expect a seroma, and aspiration should be performed by a surgeon to avoid any risk of infection. No periprosthetic capsular contracture has been observed around the implants in the long term. Unlike breast implants filled with soft silicone gel, silicone elastomer implants are semirigid; thus, we assumed that they would neither retract nor contract. In the absence of a fracture, rupture, or degradation, the prosthesis is retained for the duration of the patient’s life.

Since 2007, we have completely abandoned other procedures, such as the latissimus dorsi approach, which over time produces atrophy (sometimes leaving behind dorsal sequelae) and apparently random results, but also isolated mammary prostheses that did not respond to the actual deformation. Finally, we have never obtained sufficient and symmetric results using the lipofilling procedure alone, as reported by La Marca et al.32; this often requires three to five procedures. The other negative aspect of lipofilling for men is that they are often young, thin, and muscular patients, and thus it is difficult to find an adipose tissue donor site.

The recent study of Baldelli et al. highlights that patients should be operated on during the period of growth to allow for proper body image stabilization and improved quality of life.7 With our technique, it is possible to operate on patients relatively early, (i.e., just after puberty). If the prosthesis becomes too small, it is always possible to redo it or to perform secondary lipofilling. The mean patient age in our series was 26 years, reflecting that a large proportion of patients do not undergo correction during childhood. Psychological difficulties often develop in adolescence or adulthood, motivating consultations. Such patients are frequently seen for the first time as adults, and often request surgery that is rapid and not disabling or associated with prolonged effects on work or sports activities. Although psychological and cosmetic considerations remain the main indications for treating Poland syndrome, few studies have explored patient satisfaction and aesthetic results, and none include any work done involving computer-aided design to create silicone implants. In the present study, both men and women considered that the outcomes of the computer-aided design implants were good to excellent. In terms of overall satisfaction, 76.9 percent of women and more than 80 percent of men rated they were “were satisfied” or “very satisfied,” demonstrating that this technique gives good results in both sexes.

No specific scale to evaluate the effect of Poland syndrome on quality of life exists; thus, we used the Medical Outcomes Study 36-Item Short-Form Health Survey, which is one of the most widely used and internationally well-validated scales.15 Significant improvements in social and emotional functioning were evident in both groups, and men reported significantly greater improvements in social functioning compared with women (p < 0.001 and p = 0.096). It is likely that social functioning would also show significant improvement in women with a larger patient series. This result demonstrates that reconstruction improved patient body image.7

The reported pain associated with implant placement was highlighted on the Medical Outcomes Study 36-Item Short-Form Health Survey (bodily pain). We have not encountered this complaint before, and the literature is silent on the topic. Patients reported that they could feel their prostheses during certain intense sporting activities, which may also be the case for breast implants. We believe that the medium- and long-term pain associated with others procedures, such as thoracic remodeling surgery, latissimus dorsi flap, transverse rectus abdominis muscle flap, or a mammary implant are rarely evaluated in most studies; thus, it was difficult to compare previous cases with those of our series. Pain reports are often unreliable in retrospective studies. The experience of the prosthesis during physical effort was described more as discomfort than as pain, and only one patient requested removal of the prosthesis for pain-related reasons.

All of our demographic and surgical data were collected prospectively, but the cosmetic self-evaluation and quality-of-life assessment were retrospective in nature, and thus accompanied by the limitations inherent in retrospective reports. To the best of our knowledge, this is the largest reported series of Poland syndrome corrections using computer-aided design custom silicone implants. We also present long-term follow-up data showing the stability of the implants and outcomes. Because the implants are custom-made and all are different, they are not required in Europe to carry the European Conformity marking as is the case for classic silicone gel mammary implants.

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CONCLUSIONS

We managed patients with Poland syndrome on a strictly cosmetic basis. Custom implants designed using three-dimensional computed tomographic data afforded good to excellent cosmetic results in most patients, who were generally satisfied and enjoyed an improved quality of life, in both social and emotional terms. This procedure allows for the management of the majority of defects. Obtaining an excellent result remains difficult in patients with Poland syndrome, but three-dimensional computer-aided design has optimized our reconstructions. Nevertheless, certain associated procedures and secondary corrections remain indispensable for achieving an optimal result.

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