8
Changes over Time in Mammary Compliance Values After Breast Augmentation Marco Mazzocchi, M.D., Ph.D., Carmine Alfano, M.D., Paolo Fioramonti, M.D., and Nicolo` Scuderi, M.D. Department of Plastic and Reconstructive Surgery, University ‘‘La Sapienza’’ Rome, Rome, Italy Abstract. Capsular contracture is the most troublesome and distressing complication after breast augmentation for both the surgeon and patient. The etiology of capsular contracture remains unclear. Clinical treatment for this complication is based on the surgeonÕs evaluation, the condition of the breast, and a number of other factors. In a previous study, the authors investigated whether measure- ment of mammary compliance as a means of assessing capsular contracture was comparable with other methods described for the assessment of capsular contracture. The purpose of this study was to evaluate whether capsular contracture varies significantly over time. A prospective study was performed to measure mammary compliance in 60 female patients who received a total of 120 implants between 2000 and 2002. The implants used were anatomic prostheses filled with cohesive silicone gel and round dou- ble-lumen prostheses filled with silicone gel and saline solution. All the patients were followed up for at least 2 years. Statistical analysis of the data also was performed to assess significance. The results showed a general trend in mammary compliance values over time. Key words: Breast augmentation—Capsular contrac- ture—Mammary compliance The most frequent complication and cause of patient dissatisfaction after breast augmentation is fibrous capsular contracture, which transforms the prosthesis into a hardened sphere. The initially satisfactory cosmetic result can thus turn into an undesired, de- formed mass [9]. In the literature, the incidence of symptomatic capsular contracture ranges from 0.5% to 30% [1,11]. This wide range in the incidence of capsular con- tracture may be attributable to a number of reasons including low-grade chronic inflammation caused by a foreign body reaction, infections, the kind of im- plant used, the percentage of the patients monitored, and surgeon-related factors [7,8,12,22]. However, the mechanisms underlying the formation of the capsule and the maintenance of its contracted status are as yet unknown. Plastic surgeons commonly use a range of strate- gies to treat or prevent capsular contracture. The increase in the number of studies and reports on capsular contracture over time should help in the development appropriate treatments for this compli- cation [5,10,21]. Assessment of capsular contracture is based on the surgeonÕs judgment, breast condition, and a number of other factors. Because a proper assessment of capsular contracture is important not only for sci- entific purposes, but also for medicolegal reasons, several methods for standardizing this procedure have been described [3,4]. Currently, three methods are commonly used to measure capsular contracture: palpation, applanation tonometry, and measurement of mammary compli- ance [6,1320]. The palpation method is a clinical evaluation that divides clinical cases into four groups [3,4]. Applanation tonometry measures intramam- mary pressure. It is based on the application of a force (F) on the breast, the measurement of the contact area (A), and the subsequent calculation of intramammary pressure according to the formula P = F/A [18]. Mammary compliance, developed from the caliber of Burkhardt [6], measures mam- mary compressibility. The instrument is placed at a The authors did not receive any financial support for this study; nor were they in any way commercially involved with the companies that manufacture either the mammary compliance device or the implants. Correspondence to Marco Mazzocchi, M.D., Ph.D.,Via Portuense 331, 00149 Roma, Italy; email: mazzocc@ mclink.it Aesth. Plast. Surg. 30:198205, 2006 DOI: 10.1007/s00266-005-0165-2

Changes over Time in Mammary Compliance Values After Breast Augmentation

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Page 1: Changes over Time in Mammary Compliance Values After Breast Augmentation

Changes over Time in Mammary Compliance Values After Breast Augmentation

Marco Mazzocchi, M.D., Ph.D., Carmine Alfano, M.D., Paolo Fioramonti, M.D., and Nicolo Scuderi, M.D.

Department of Plastic and Reconstructive Surgery, University ‘‘La Sapienza’’ Rome, Rome, Italy

Abstract. Capsular contracture is the most troublesome

and distressing complication after breast augmentation forboth the surgeon and patient. The etiology of capsularcontracture remains unclear. Clinical treatment for this

complication is based on the surgeon�s evaluation, thecondition of the breast, and a number of other factors. In aprevious study, the authors investigated whether measure-

ment of mammary compliance as a means of assessingcapsular contracture was comparable with other methodsdescribed for the assessment of capsular contracture. Thepurpose of this study was to evaluate whether capsular

contracture varies significantly over time. A prospectivestudy was performed to measure mammary compliance in60 female patients who received a total of 120 implants

between 2000 and 2002. The implants used were anatomicprostheses filled with cohesive silicone gel and round dou-ble-lumen prostheses filled with silicone gel and saline

solution. All the patients were followed up for at least 2years. Statistical analysis of the data also was performed toassess significance. The results showed a general trend in

mammary compliance values over time.

Key words: Breast augmentation—Capsular contrac-ture—Mammary compliance

The most frequent complication and cause of patientdissatisfaction after breast augmentation is fibrouscapsular contracture, which transforms the prosthesisinto a hardened sphere. The initially satisfactory

cosmetic result can thus turn into an undesired, de-formed mass [9].

In the literature, the incidence of symptomaticcapsular contracture ranges from 0.5% to 30% [1,11].This wide range in the incidence of capsular con-tracture may be attributable to a number of reasonsincluding low-grade chronic inflammation caused bya foreign body reaction, infections, the kind of im-plant used, the percentage of the patients monitored,and surgeon-related factors [7,8,12,22]. However, themechanisms underlying the formation of the capsuleand the maintenance of its contracted status are asyet unknown.

Plastic surgeons commonly use a range of strate-gies to treat or prevent capsular contracture. Theincrease in the number of studies and reports oncapsular contracture over time should help in thedevelopment appropriate treatments for this compli-cation [5,10,21].

Assessment of capsular contracture is based on thesurgeon�s judgment, breast condition, and a numberof other factors. Because a proper assessment ofcapsular contracture is important not only for sci-entific purposes, but also for medicolegal reasons,several methods for standardizing this procedurehave been described [3,4].

Currently, three methods are commonly used tomeasure capsular contracture: palpation, applanationtonometry, and measurement of mammary compli-ance [6,13�20]. The palpation method is a clinicalevaluation that divides clinical cases into four groups[3,4]. Applanation tonometry measures intramam-mary pressure. It is based on the application of aforce (F) on the breast, the measurement of thecontact area (A), and the subsequent calculation ofintramammary pressure according to the formulaP = F/A [18]. Mammary compliance, developedfrom the caliber of Burkhardt [6], measures mam-mary compressibility. The instrument is placed at a

The authors did not receive any financial support for thisstudy; nor were they in any way commercially involved withthe companies that manufacture either the mammarycompliance device or the implants.

Correspondence to Marco Mazzocchi, M.D., Ph.D.,ViaPortuense 331, 00149 Roma, Italy; email: [email protected]

Aesth. Plast. Surg. 30:198�205, 2006DOI: 10.1007/s00266-005-0165-2

Page 2: Changes over Time in Mammary Compliance Values After Breast Augmentation

level between the areola and the inframammary foldto measure the maximum diameter. Compressionthen is applied to obtain the minimum diameter.The measurement of compressibility is obtained by

calculating the difference between the two measure-ments. This system was improved by Hoflehner [17],who measured the distance between the two sensorswhen a known force was applied, thereby obtainingthe measurement according to the following formula:

DXn ¼ DX 10=mammary diameter;

where DX represents the applied force and themammary diameter represents the diameter measuredon the detector�s point of contact [16,17].Previous studies have reported a good agreement

between clinical and objective measurements of cap-sular contracture, as well as between applanationtonometry and mammary compliance [2]. The AntonPaar Mammacompliance System seems to be effectivein eliminating the descriptive part while keeping tothe measurements and objective data. Moreover, thissystem is easily reproducible during checkups andprovides an objective assessment of capsularcontracture.No studies in the literature have yet assessed the

trend in capsular contracture by means of an objec-tive system. This study aimed to evaluate whethercapsular contracture varies significantly over timeand whether any differences exist between anatomicprostheses filled with cohesive silicone gel and rounddouble-lumen prostheses filled with silicone gel andsaline solution. We designed a prospective study ofcapsular contracture with a series of patients whounderwent mammary augmentation to evaluate thegrade of capsular contracture over time by measuringmammary compliance with the Anton Paar Mam-macompliance System (Polytech Europe) DieburgGermany.

Materials and Methods

For the purposes of this study, we considered, fromamong all the patients who received mammary im-plants in the Department of Plastic Surgery at theUniversity of Rome ‘‘La Sapienza’’ between 2000 and2002, 60 female patients in whom 120 prostheses wereimplanted. Of these patients, 30 received 60 anatomicimplants filled with cohesive silicone gel, and theremaining 30 patients received 60 round double-lu-men implants filled with silicone gel and saline solu-tion. We excluded patients in whom we implanted adifferent prosthesis, patients with a history of medicalor surgical treatment of the breast, patients withchronic disease of the skin (psoriasis, sclerodermitis),and patients older than 40 years. The ages of thepatients ranged between 18 and 40 years (mean, 31

years and 6 months; median, 29 years). The size of theimplants ranged from 165 to 390 g for the anatomicimplants, and from 200 to 400 ml for the rounddouble-lumen implants.

All the double-lumen implants were filled with therecommended amount of saline solution, and all theimplants had a textured shell. An inframammaryapproach and a retromammary pocket location wereused for all the patients. Follow-up visits werescheduled 1, 4, 12, and 24 months after the surgicalprocedure.

Clinical evaluation was performed by two differentoperators. The hardness of the breasts was evaluated1 month (T1), 4 months (T2), 12 months (T3), and 24months (T4) after surgery, with one operator usingthe palpation method according to Baker�s classifi-cation and the other operator using the Anton PaarMammacompliance System.

Palpation is a clinical assessment that dividesclinical cases into four groups. The first group con-sists of patients with breasts found to be normal atboth inspection and palpation (i.e., their consistencyis the same as that of a breast that has not undergonesurgery). In the second group, the breast inspectionresults are normal, but the palpation results are not(i.e., the implant is palpable, although not visible, andthe consistency of the breast is harder). In the thirdgroup, both the inspection and palpation results areabnormal (i.e., the breast is hard, and the prosthesis iseasily palpable, with visible distortion of the breastcontours). The fourth group consists of patients whoreport mammary tension and mastalgia (i.e., the im-plant and overlying skin are evident).

The Anton Paar Mammacompliance System devicemeasures the distance between two sensors onapplication of a known force. A seated patient issubjected to breast constriction, which then is mea-sured with the appropriate instrument (Fig. 1). Themeasurement starts when a base value of 0.5 isachieved and ends when a value exceeding 15 new-tons (N) is reached. The diameter of the breast ismeasured when forces of 0.5 N and 15 N are applied.Such measurements are used to calculate the mam-mary compliance according to the following formula:

D15¼ d15 � 100%=d0½%�;

where D15 is the mammary compliance, and d15 andd0 represent the mammary diameter measured inmillimeters with respect to forces of 15 and 0.5 N.Each breast is measured in eight different positions,and the arithmetic mean of the various measurementsis then calculated.

All the work is performed by a computer thatdevelops both a numeric value and a diagram of thecompliance showing the softness of the breast. Themammary compliance value, determined according toBaker�s method of palpation, usually ranges from29.2 to 44.1 in cases with grade I capsular contrac-

M. Mazzochi et al. 199

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ture, from 40.1 to 52.2 in cases with grade II capsularcontracture, from 48.6 to 61.9 in cases with grade IIIcapsular contracture, and from 55.3 to 75.8 in caseswith grade IV capsular contracture [22].None of the operators were aware of the result for

the other measurement, and all the mammary com-pliance data were compared with clinical evidence ofcapsular contracture according to Baker�s classifica-tion at the end of the study.A statistical analysis of the data was performed

using the t-test to verify significance. In particular, wecompared mammary compliance measurements fromthe same implant at different times. All p values lessthan 0.05 were considered significant. Baseline datarepresented measures of compression resistance. Datawere obtained from the same individual at T1, T2,T3, and T4.

Results

The overall mean mammary compliance values were54.31 at T1, 45.98 at T2, 47.88 at T3, and 48.64 at T4.When the two implants were considered separately,the mean value of mammary compliance was 50.20 atT1, 43.52 at T2, 44.84 at T3, and 45.70 at T4 for thedouble-lumen implant, and 58.43 at T1, 48.44 at T2,50.93 at T3, and 51.59 at T4 for the anatomic im-plant. (Tables 1 and 2; Figs. 2 and 3) When thehardness of the breasts was grade I according toBaker�s classification, the mean value of mammarycompliance was 43.46 at T1 in 38 cases (31.7%), 37.79at T2 in 42 cases (35.0%), 38.75 at T3 in 42 cases(35.0%), and 39.79 at T4 in 42 cases (35.0%).We observed grade II capsular contracture with a

mammary compliance value of 52.17 at T1 in 25 cases

(20.8%), 47.26 at T2 in 54 cases (45.0%), 48.55 at T3in 47 cases (39.2%), and 48.92 at T4 in 47 cases(39.2%). We observed grade III capsular contracturewith a mammary compliance value of 62.49 at T1 in57 cases (47.5%), 57.43 at T2 in 24 cases (20.0%),55.95 at T3 in 22 cases (18.3%), and 56.94 at T4 in 22cases (18.3%). We did not observe any cases of gradeIV capsular contracture at T1 or T2, although weobserved 9 cases (7.5%) at T3 with a mammarycompliance value of 67.27 and 9 cases (7.5%) at T4with a value of 68.22.

Our data show that the value of mammary com-pliance ranged from 30.2 to 44.5 (mean, 39.86) incases with grade I capsular contracture according toBaker�s palpation method, from 40.7 to 56.9 (mean,48.77) in cases with grade II capsular contracture,from 47.5 to 65.6 (mean, 59.39) in cases with grade IIIcapsular contracture, and from 59.3 to 75.8 (mean,67.75) in cases with grade IV capsular contracture.

The statistical analysis, performed with the t-test,showed that the measurement of mammary compli-ance after breast augmentation using the double-lu-men implants did not differ statistically between T2and T3, T2 and T4, or T3 and T4. Rather, the dif-ference was significant between T1 and all the sub-sequent follow-up assessments. With regard to theanatomic prosthesis, between T3 and T4, the T var-iable was not significant (Table 3).

Discussion

Adverse capsular contracture is the most commoncomplication of breast augmentation [9,10]. Al-though capsule formation is accepted as part of thehealing process and can be associated with any type

Fig. 1. Compliance measurement.

200 Mammary Compliance Values After Breast Augmentation

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Table 1. Mammary compliance values and capsular contracture grades, as determined according to Baker�s method ofpalpation for anatomic prostheses filled with cohesive silicone gel

Anatomic implants

T1 (1 month) T2 (4 month) T3 (12 months) T4 (24 months)

Compl. Baker Compl. Baker Compl. Baker Compl. Baker

1 65.0 III 51.8 II 53.9 II 54.3 II2 65.0 III 60.4 III 61.9 III 63.5 III3 51.7 II 42.9 II 47.0 II 48.5 II4 64.4 III 58.4 III 60.9 III 62.0 III5 64.4 III 63.4 III 61.3 IV 62.3 IV6 44.9 I 31.6 I 36.4 I 38.3 I7 64.7 III 62.7 III 67.1 IV 70.3 IV8 65.2 III 64.4 III 71.3 IV 71.5 IV9 64.3 III 62.1 III 70.7 IV 71.1 IV10 64.9 III 55.6 III 64.3 III 63.9 III11 65.1 III 63.8 III 67.4 IV 67.7 IV12 60.8 III 46.1 II 47.3 II 48.4 II13 44.3 I 36.3 I 40.8 I 41.3 I14 64.7 III 55.3 III 52.9 III 54.4 III15 44.4 II 42.5 I 42.7 I 43.3 I16 63.9 III 54.9 III 59.3 III 61.4 III17 51.3 II 43.7 I 44.7 I 44.5 I18 61.3 III 54.5 III 60.0 III 61.5 III19 65.0 III 48.9 III 51.6 II 54.6 II20 65.1 III 49.3 II 51.7 II 52.6 II21 64.3 III 49.5 II 51.8 II 49.3 II22 44.1 I 38.8 I 41.2 I 41.8 I23 44.6 I 41.4 I 42.8 I 43.0 I24 44.3 I 39.9 I 41.3 I 41.7 I25 45.0 I 38.9 I 38.2 I 39.4 I26 44.3 I 39.1 I 39.0 I 40.3 I27 44.1 I 39.7 I 40.2 I 41.3 I28 61.9 III 48.3 II 49.3 II 49.1 II29 62.3 III 48.3 II 49.5 II 50.7 II30 44.3 I 38.5 I 42.5 I 43.6 I31 52.4 II 43.6 I 43.3 I 43.9 I32 53.6 II 43.9 II 46.4 II 45.7 II33 52.1 II 45.4 II 46.9 II 44.9 II34 64.6 III 51.0 II 50.9 II 52.3 II35 64.9 III 51.4 II 51.1 II 50.8 II36 62.4 III 46.3 II 48.1 II 47.9 II37 52.1 II 46.7 II 48.1 II 47.9 II38 56.7 III 46.9 II 49.2 II 49.1 II39 56.3 II 47.0 II 49.3 II 51.4 II40 64.5 III 55.0 III 60.4 III 63.9 III41 63.5 III 56.9 III 60.6 III 61.6 III42 56.8 II 48.0 II 48.9 II 49.3 II43 64.8 III 48.1 II 49.0 II 50.3 II44 64.2 III 48.2 II 49.0 II 48.8 II45 64.1 III 51.3 III 57.7 III 56.5 III46 44.1 I 39.4 I 41.6 I 42.0 I47 64.4 III 49.7 II 50.1 II 49.6 II48 64.7 III 47.4 II 50.4 II 49.8 II49 64.9 III 47.6 II 51.3 II 52.7 II50 64.8 III 47.5 II 51.3 II 52.7 II51 64.3 III 48.9 II 50.7 II 51.2 II52 56.1 II 44.9 II 47.7 II 47.4 II53 65.1 III 50.6 II 51.2 II 51.7 II54 65.3 III 51.6 II 55.8 III 55.6 III55 65.4 III 52.0 II 56.6 III 58.3 III56 63.9 III 50.2 II 50.3 III 51.4 III

M. Mazzochi et al. 201

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of implant, it is not known why some capsules con-tract, causing hardness and patient discomfort. Nor isit possible to predict whether a capsule will contractor not.The data from our series confirm what we observed

in a previous study: Good agreement exists betweenthe value of mammary compliance and the clinicalassessment using methods such as Baker�s palpationmethod, and this assessment is easily reproducible infollow-up visits [22]. The measurement of capsularcontracture by palpation according to Baker�s meth-od depends above all on the experience and sensitivityof the operator. Moreover, the results can be neitherreproduced nor documented.This study also confirms that the measurement of

mammary compliance as a means of defining capsu-lar contracture appears to yield reliable results and toeliminate the descriptive part effectively, therebyproviding data based on more objective measure-ments. Mammary compliance measurement is easy toperform because it depends to a large extent on theoperator, and thus is easy to reproduce [18,21,22]. Allthe work is performed by the computer. The resultsmay be either recorded or stored directly in a com-puter using an analogue data acquisition interface. Ineither case, it is possible to assess the graphs and storethem for subsequent comparisons. Because compli-ance measurements have a high degree of sensitivity,they are suited to both long-term follow-up studiesand studies designed to assess the effectiveness oftherapy.Great importance is attributed to graphs because

they may show the severity of capsular contracture.Curvilinear graphs indicate mild capsular contrac-ture, whereas rectilinear graphs indicate severe cap-sular contracture [22].We observed, in our study with the Anton Paar

Mammacompliance System a particular pattern ofcapsular contraction, with higher values during thefirst month followed by a lowering of values in thefourth month. The initial high values were, in ouropinion, because of the postsurgical edema that in-duces breast hardening and lasts for the first fewmonths.We also noticed that the values obtained from the

fourth month were stable thereafter, rising veryslightly. We therefore believe that the fourth month

value is the most accurate in predicting whethercontraction will develop. Indeed, our data show thatwhen the value of mammary compliance drops be-tween the first and fourth months, the capsule willnot undergo early contraction, although there is, bycontrast, a high possibility of rapidly developingcapsular contracture. The fact that there is a signifi-cant decrease in the value of mammary compliancebetween the measurements at 1 and 4 months con-firms this observation.

Our data show that for both types of implantstudied, the value of mammary compliance reaches,over time, a stable level, with no statistically signifi-cant difference between measurements at 1 and 2years. Only for patients in whom capsular contrac-ture developed was there not a decrease in the valuebetween the follow-up assessments at 1 and 4 months.We also observed an increase in mammary compli-ance in these patients over time. The existence of asignificant difference in the values of mammarycompliance with the anatomic implant at the 1-, 4-and 12-month follow-up assessments shows, in ouropinion, that these cases involve a further adjustmentbetween the implant and the periprosthetic capsule.In the subsequent follow-up visits, these values sta-bilize, as occurs with the other type of implant.

The patients who received a cohesive gel-filledanatomic implant had higher mammary compliancethan the patients who received round double-lumenimplants filled with silicone gel and saline solution.This discrepancy is clearly attributable to the differ-ent hardness values of the implants. An implant filledwith cohesive silicone gel is bound to be harder andless compressible than a double-lumen implant filledwith silicone gel and saline solution. We should alsobear in mind that an implant filled with saline solu-tion may bleed, thereby resulting in a softer implantand, consequently, a lower mammary compliancevalue. By contrast, the hardness of the anatomicprostheses filled with cohesive silicon gel remainsunchanged even if the implant leaks or breaks.

Conclusion

We observed, with both types of implant studied, thesame trend in mammary compliance values, with the

Table 1. Continued

Anatomic implants

T1 (1 month) T2 (4 month) T3 (12 months) T4 (24 months)

Compl. Baker Compl. Baker Compl. Baker Compl. Baker

57 44.3 I 30.9 I 31.0 I 32.6 I58 56.9 II 43.1 II 44.7 II 43.8 II59 64.7 III 48.9 II 56.0 III 56.5 III60 64.3 III 52.9 III 59.3 III 60.2 III

202 Mammary Compliance Values After Breast Augmentation

Page 6: Changes over Time in Mammary Compliance Values After Breast Augmentation

Table 2. Mammary compliance values and capsular contracture grades, as determined according to Baker�s method ofpalpation for round double-lumen prostheses filled with silicone gel and saline solution

Double lumen implants

T1 (1 month) T2 (4 month) T3 (12 months) T4 (24 months)

Compl. Baker Compl. Baker Compl. Baker Compl. Baker

1 44.6 I 38.5 I 36.8 I 36.6 I2 43.6 I 37.6 I 39.3 I 41.5 I3 61.3 III 53.9 III 54.5 III 53.9 III4 40.9 I 30.2 I 30.9 I 35.5 I5 62.3 III 61.9 III 66.8 IV 67.5 IV6 41.2 I 33.9 I 33.8 I 34.7 I7 48.1 II 42.6 II 43.9 II 43.8 II8 40.1 I 32.8 I 33.0 I 34.6 I9 40.4 I 34.0 I 33.0 I 32.8 I10 41.1 I 33.8 I 32.4 I 36.3 I11 40.5 I 35.3 I 33.3 I 35.9 I12 43.6 I 32.5 I 32.4 I 35.6 I13 43.4 I 35.9 I 41.0 I 40.2 I14 43.9 I 37.3 I 37.0 I 38.1 I15 51.7 II 42.9 I 43.2 I 44.1 I16 61.8 III 61.2 III 75.8 IV 73.9 IV17 51.9 II 52.9 III 48.2 III 50.1 III18 43.8 I 37.1 I 36.9 I 37.2 I19 43.9 I 36.7 I 34.4 I 35.1 I20 50.9 II 44.1 II 44.1 II 45.3 II21 51.7 II 41.3 II 40.7 II 44.3 II22 43.1 I 36.1 I 35.1 I 34.9 I23 51.0 II 43.3 II 45.3 II 46.8 II24 43.5 I 35.8 I 35.9 I 37.9 I25 44.4 I 40.7 I 42.1 I 43.5 I26 43.9 I 40.2 I 42.6 I 41.9 I27 43.3 I 41.1 I 42.8 I 44.5 I28 43.8 I 41.7 I 43.0 I 44.4 I29 43.2 I 36.9 I 37.4 I 40.1 I30 43.7 I 37.1 I 38.3 I 39.0 I31 43.9 I 39.2 I 40.0 I 39.9 I32 61.7 III 48.8 II 49.1 II 47.6 II33 52.2 II 41.8 II 43.9 II 43.6 II34 51.2 II 43.7 II 46.5 II 47.7 II35 51.4 II 45.7 II 47.5 III 45.8 III36 51.8 II 41.2 II 51.1 III 54.4 III37 51.8 II 45.6 II 45.1 II 46.9 II38 58.1 III 47.1 II 48.4 II 49.5 II39 54.1 III 53.4 III 54.4 III 57.4 III40 58.4 III 47.5 II 48.5 II 48.7 II41 60.1 III 47.7 II 48.8 II 49.1 II42 42.4 I 39.3 I 40.3 I 41.5 I43 59.5 III 48.4 II 49.7 II 51.3 II44 59.7 III 48.4 II 49.8 II 50.3 II45 59.9 III 50.3 II 49.9 II 49.7 II46 60.6 III 48.9 II 50.3 II 49.8 II47 44.3 I 40.0 I 42.4 I 42.6 I48 44.1 I 37.9 I 40.9 I 41.6 I49 44.7 I 40.0 I 42.5 I 43.4 I50 52.2 II 46.1 II 47.9 II 47.4 II51 52.7 II 46.2 II 48.0 II 49.2 II52 60.7 III 50.1 II 48.6 III 49.2 III53 61.1 III 50.1 II 52.8 III 53.9 III54 51.9 II 46.2 II 48.3 II 47.4 II55 43.9 I 38.4 I 41.4 I 40.9 I56 55.3 III 56.3 III 59.3 IV 60.6 IV

M. Mazzochi et al. 203

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Table 2. Continued

Double lumen implants

T1 (1 month) T2 (4 month) T3 (12 months) T4 (24 months)

Compl. Baker Compl. Baker Compl. Baker Compl. Baker

57 57.9 III 52.7 III 58.0 III 57.3 III58 61.2 III 65.6 III 65.8 IV 69.1 IV59 57.7 III 47.6 II 48.6 II 48.0 II60 56.9 III 47.7 II 48.7 II 48.3 II

Fig. 2. Changes over time in mammary compliance values of anatomic prostheses filled with cohesive silicone gel.

Fig. 3. Changes over time in mammary compliance values of round double-lumen prostheses filled with silicone gel and salinesolution.

204 Mammary Compliance Values After Breast Augmentation

Page 8: Changes over Time in Mammary Compliance Values After Breast Augmentation

highest values recorded during the first month,followed by lower values at the fourth month. Thesemammary compliance values were found to stabilizeeventually at 1 and 2 years. We therefore believe thatthe month 4 value of mammary compliance accu-rately predicts whether an early contraction of theperiprosthetic capsule will develop. Indeed, when themammary compliance value drops between months 1and 4, the capsule does not, in our experience, un-dergo early contraction, although there is a highpossibility that capsular contracture will develop.We cannot predict whether a capsule will contract

during its life span, but the changes over time thatoccur in the measurement of mammary compliance atfollow-up visits can show signs of increased breasthardness, thereby allowing action to be taken toavoid possible capsular contraction. We believe thatthis study is useful insofar as it sheds light on theundesired complication of capsular contracture afterbreast augmentation surgery.

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Table 3. Statistical analysis using t-test and the resultingp values

Time p value

Double lumen implants < 0.001T1 � T2 < 0.001T1 � T3 0.0020T1 � T4 0.0082T2 � T3 0.3429T2 � T4 0.1121T3 � T4 0.5714

Anatomic implants

T1 � T2 < 0.0001T1 � T3 < 0.0001T1 � T4 < 0.0001T2 � T3 0.0677T2 � T4 0.0235T3 � T4 0.6627

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