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Nonsurgical Breast Enlargement Using an External Soft-Tissue Expansion System

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Nonsurgical Breast Enlargement Using an External Soft-Tissue Expansion System Cosmetic Nonsurgical Breast Enlargement Using an External Soft-Tissue Expansion System Roger K. Khouri, M.D., Ingrid Schlenz, M.D., Brian J. Murphy, M.D., and Thomas J. Baker, M.D. Key Biscayne and Miami, Fla. Less than 1 percent of the women interested in having Approximately 16 to 19 million women in larger breasts elect to have surgical augmentation mam- the United States between the ages of 18 and maplasty with insertion of breast implants. The purpose of this report is to describe and test the efficacy of a non- 49 have an expressed interest in breast enlarge- 1,2 surgical method for breast enlargement that is based on ment ; however, despite a resurgence in pop- the ability of tissues to grow when subjected to controlled ularity, only about 130,000 (0.7 percent) of distractive mechanical forces. Seventeen healthy women these women underwent surgical breast aug- (aged 18 to 40 years) who were motivated to achieve breast mentation in 1998.3 Reluctance to undergo enlargement were enrolled in a single-group study. The participants were asked to wear a brassiere-like system that surgery for cosmetic reasons, perceived adverse applies a 20-mmHg vacuum distraction force to each sequelae from the implants, and cost are the breast for 10 to 12 hours/day over a 10-week period. Breast most cited deterrents to this surgical recourse.2 size was measured by three separate methods at regular We developed a system and a method of intervals during and after treatment. Breast tissue water external soft-tissue expansion and tested its ef- density and architecture were visualized before and after treatment by magnetic resonance imaging scans obtained ficacy as a nonsurgical alternative for breast in the same phase of the menstrual cycle. Twelve subjects enlargement. The principle behind this ap- completed the study; five withdrawals occurred due to proach is the capacity of tissues to grow when protocol noncompliance. Breast size increased in all subjected to sustained, low-level, mechanical women over the 10-week treatment course and peaked at distraction. For centuries, tribes from several week 10 (final treatment); the average increase per woman was 98 Ϯ 67 percent over starting size. Partial cultures have applied this principle to enlarge recoil was seen in the first week after terminating treat- various body parts.4,5 Surgically implanted tis- ment, with no significant further size reduction after up sue expanders are now routinely used in plastic to 30 weeks of follow-up. The stable long-term increase in surgery to incrementally increase the amount breast size was 55 percent (range, 15 to 115 percent). of skin and soft tissue available to perform Magnetic resonance images showed no edema and con- 6–8 firmed the proportionate enlargement of both adipose multiple staged reconstructive procedures. and fibroglandular tissue components. A statistically sig- Orthopedic experience with the Ilizarov proce- nificant decrease in body weight occurred during the dure has demonstrated the feasibility of length- course of the study, and scores on the self-esteem ques- ening extremities by a process of gradual dis- tionnaire improved significantly. All participants were very pleased with the outcome and reported that the de- traction that grows the bones and associated 9–11 vice was comfortable to wear. No adverse events were soft tissues. New devices have extended the recorded during the use of the device or after treatment. use of this principle to advance facial bones We conclude that true breast enlargement can be and correct retruded faces.12,13 Cell biologists achieved with the daily use of an appropriately designed have devoted considerable research toward external expansion system. This nonsurgical and nonin- vasive alternative for breast enlargement is effective and elucidating the mechanism of mechanotrans- well tolerated. (Plast. Reconstr. Surg. 105: 2500, 2000.) duction, the process by which mechanical ten- Received for publication December 1, 1999; revised February 7, 2000. Presented in part at the Annual Meeting of the American Society for Aesthetic Plastic Surgery, in Dallas, Texas, May 16, 1999, and at the 10th Anniversary Meeting of the European Association of Plastic Surgeons, in Madrid, Spain, May 21, 1999. Roger K. Khouri, M.D., is a shareholder of Biomecanica, Inc. None of the other authors have any financial interest in or have received any direct benefit from Biomecanica, Inc., except for Ingrid Schlenz, M.D., who received partial salary support from Biomecanica, Inc., during the study period. 2500 Vol. 105, No. 7 / NONSURGICAL BREAST ENLARGEMENT 2501 sion is converted into growth-promoting sig- of 15 to 25 mmHg. To document protocol nals.14–17 compliance, the microcomputer records tem- Current therapeutic applications of tension- perature and pressure every 10 minutes and induced tissue growth require surgical inter- stores the data in its memory. vention to insert either an inflatable silicone A number of suction-based devices have shell as the force-transducing device or bone touted the ability to induce breast enlarge- pins and screws as links to the distraction ment.18 These are considered to be mostly in- frame; however, the approach presented here effective novelty items and are ridiculed by the is entirely nonsurgical. Sustained, low-level establishment in plastic surgery.19 Although negative pressure (vacuum) provides the out- the basic idea behind stretching to induce en- ward distractive force that stimulates breast tis- largement is sound, these novelty devices lack sue enlargement. The nonsurgical breast- the necessary design elements to appropriately enlargement system was designed by one of the deliver, over a prolonged period of time, a authors (R.K.K.); in a pilot study on two sub- sustained, controlled mechanical distraction to jects (four breasts), he found evidence that the cause breast growth. device was effective (unpublished data). The We built the system by deliberately taking present study represents an independent test into account known physiologic constraints of its safety and efficacy in a larger population. and bioengineering principles. Pilot testing of a succession of prototypes led us to identify MATERIALS AND METHODS and refine four novel critical design features that ensure safe and effective function (U.S. Soft-Tissue Expansion patent #5536,233; U.S. patent #5662,583; U.S. The nonsurgical breast-enlargement system patent #5676,634; U.S. patent #5695,445; U.S. incorporates two semirigid plastic domes, each patent #5701,917; and other patents pending). slightly larger in volume than the correspond- ing breast to be enlarged. A brassiere garment Balancing of Forces and Optimization of Pressures supports the two domes, and the device is worn The total outward force (Fout) exerted by the like a brassiere (Fig. 1). Each dome has an vacuum on the breast is equal to the product of outlet port for vacuum application and a gel- the aperture area of the dome (A) and the filled bladder at the rim that circumscribes the vacuum pressure (Pv). This force is balanced by outer margins of the breast. An adhesive, hy- an equal counter-force against the chest skin poallergenic silicone gel applied to the skin- under the bladder rim (Fin) that is equal to the contact surface of each bladder maintains a product of the area of the bladder rim (R) and vacuum seal with the skin. A battery-powered, the pressure transferred to the skin (Ps). Cap- microcomputer-controlled vacuum pump is illary perfusion starts to drop precipitously connected to outlet ports on each dome by when the pressure (whether positive or nega- plastic tubing. Pressure sensors and relief tive) exerted on the skin and underlying tissues valves are used to maintain a vacuum pressure exceeds 20 to 30 mmHg.20–23 Sustained pres- FIG.1.(Left) Diagram showing the translucent plastic domes and gel-filled bladder rims placed over the breasts. The microcomputer-controlled vacuum pump fits inside a pocket of the brassiere garment. (Right) Photograph of the nonsurgical breast-enlargement system as worn by a participant in the study. 2502 PLASTIC AND RECONSTRUCTIVE SURGERY, June 2000 sures above this limit lead to tissue damage. To Control of Shear Forces on the Skin maximize distraction without compromising The inward pull of expansion stretches the the circulation of the distracted breast or that breast skin close to the limit of its elastic defor- of the compressed skin under the rim, the mation. absolute values of Ps and Pv must equal this At the periphery of the breast, if the skin is upper limit of tissue tolerance. This optimiza- held firmly by the inner lip of the bladder rim, tion of the absolute pressures requires the area this stretch imparts a strong shearing force (Fs) of the bladder rim (R) to be equal to the to the skin, which can combine locally with the aperture area of the dome (A), as shown in the counter-force (Fin) to cause peripheral skin following equations. blistering and breakdown.24 To reduce this po- ϭ tentially damaging shear force, the peripheral Fin Fout breast skin under the inner lip of the rim should not be fixed but allowed to move in- ϫ ϭ ϫ A Pv R Ps ward. To accomplish that, the rim must deflect radially inward for the distance needed to re- ϭ ϭ If Pv Ps, then R A cruit additional skin and reduce the shear stress to a tolerable level. In addition, this fea- The skin contact area of the rim bladder is ture reduces skin stretching and the resultant therefore designed to be approximately equal undesirable skin expansion, while focusing the to the area of the aperture of the dome (Fig. distraction on the deeper breast tissue. 2). This constraint can only be avoided if the Through a succession of prototypes, we found pressure is allowed to alternate, decreasing the that a rim bladder approximately 2.5 cm high vacuum level every few minutes to allow the provides the necessary arc of inward deflection skin under the rim to reperfuse, and then re- (Fig.
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