The Fallacy of the Bioengineered Breast

THE FALLACY OF THE BIOENGINEERED BREAST At the 2026 Spring Meeting of the American Society of Plastic Surgeons, Dr. Movassaghi gave the lead-off presentation in a panel on breast surgery.1 His talk was titled, “Use of Mesh in Reduction and Mastopexy in the Bioengineered Breast.” This panelist referenced an article by Maxwell and Gabriel that introduced the term “bioengineered breast”2 to describe the use of acellular dermal matrix (ADM) during breast reconstruction in combination with fat grafting. Implantable mesh was a prominent topic in the Breast section of the 2026 Aesthetic Society meeting.3 A 5-surgeon panel was titled, “Soft Tissue Support in Aesthetic Breast.” A 2-hour teaching course discussed “Advanced Techniques of Soft Tissue Support in Breast Surgery.” The Global Hot Topics session included an update on the “Breast Scaffold.” Educational courses on secondary augmentation/mastopexy, “A Lift that Lasts,” and “Optimizing Outcomes” all included recommendations for mesh. Implantable mesh and autoaugmentation were considered “emerging approaches” in a 2025 Continuing Medical Education article endorsing these concepts.4 Mesh has intuitive appeal.5 Patients are told that the material dissolves, but before doing so, it supports the breast like an “internal bra.” The concept has taken hold in plastic surgery. Should plastic surgeons routinely offer implantable products to patients? This is an important question because the most common indication, treatment and prevention of breast ptosis, is so prevalent. Safety Although disclosing regulatory status is a requirement of our journals and societies,6 the fact that no mesh or ADM has received clearance from the US Food and Drug Administration (FDA) for its use in cosmetic or reconstructive breast surgery4,5 may be overlooked.2 Patients do encounter complications from mesh, and revisions may be needed.7 Plaintiff law firms are taking notice.8 Mesh may be palpable and adhere to the skin or extrude.1,7 It may increase the risk of infection.7 This product also increases the cost of surgery for patients by about €1500 ($1700).9 To suture mesh across the exposed parenchyma of the lower pole, surgeons use mastopexy techniques that measurements have shown to be inferior to a vertical mastopexy.5 An inferiorly or centrally-based deepithelialized pedicle is developed on which to suture the mesh.1 However, lower pole tissue should be excised when performing a mastopexy.5 Preserving lower pole parenchyma risks producing a “mastopexy wrecking bulge.”10 An advantage of the vertical mammaplasty is side-to-side approximation of the vertical pillars, cinching the lower pole, elevating the inframammary fold and pedicle, and minimizing the degree of repositioning needed for the nipple/areola complex.11,12 The junction of a vertical and horizontal incision is predisposed to delayed wound healing.5 This inverted-T junction is usually avoided in a vertical mastopexy.11,12 A short horizontal scar may be included to avoid a dog ear, although simultaneous implant insertion reduces the need for this modification.11 By contrast, a Wise pattern produces a long horizontal “anchor” scar that is disliked by patients.13 Blood supply to the nipple and areola is jeopardized, especially when using a long inferior pedicle.11,14 Nipple sensation is compromised.15 A Wise pattern is not ideal when inserting a breast implant simultaneously, which is common today (augmentation/mastopexy).12 A vertical mammaplasty with a short medial or superomedial pedicle is safer for perfusion of the nipple/areola complex.14 Some surgeons describe mesh as an “insurance policy” that reduces the need for reoperation for recurrent ptosis.9 Patients may be unaware that a suboptimal breast dissection is needed, an approach that many surgeons today regard as obsolete.5 The disadvantages of this surgical technique with regard to geometry (trading projection for width rather than the reverse), scarring, and safety must be considered in a risk/benefit analysis.5,11,12 Plastic surgeons report using Betadine to paint the exposed breast tissue before application of mesh1 or povidone-iodine solution to irrigate the breast tissue and mesh.16 Betadine is nonsterile and cytotoxic; this topical antiseptic is not authorized for application in an open wound.17 Efficacy Movassaghi1 referenced a 2022 review article evaluating ptosis correction in mastopexy and breast reduction, co-authored by Rohrich.18 This speaker reported that the authors of this review found evidence supporting mesh when evaluating nipple-inframammary fold (N-IMF) distances. Movassaghi1 highlighted 4 articles from this review,19–22 and reported that between 25% and 80% of patients who did not receive a scaffold demonstrated bottoming out at 1 year, compared with 5% to 8% of patients who did receive a scaffold. The source of these ranges is unclear; they were not included in the review.18 In fact, only 1 of the 4 highlighted studies evaluated mesh.22 The other 3 studies compared mastopexy and breast reduction methods with regard to pedicle orientation19,20 and a parenchymal dissection intended to simulate a hammock.21 Only 1 publication in the review compared N-IMF distances in patients treated with and without mesh.22 A study of breast reconstruction patients evaluated the contralateral breast treated with a mastopexy. József et al22 reported that women receiving mesh demonstrated a mean increase of 0.5 cm in this distance versus 0.75 cm for controls. The authors did not indicate whether this difference (0.25 cm) was significant. Hamdi et al16 evaluated lower-pole distances in mastopexy patients without controls, reporting lower-pole elongation in 20% of patients treated with Vicryl mesh (Ethicon, Raritan, NJ) at a mean follow-up of 3 years. The patient with the longest follow-up, 9 years, demonstrated a 33% increase (9 to 12 cm) despite the inclusion of Vicryl mesh (Fig. 1).FIGURE 1: A–C, This 29-year-old woman underwent a bilateral “volume distribution mastopexy.” The nipple-areola complex was maintained on a superior pedicle. The authors report that a septum-based flap was secured to the chest wall using Vicryl mesh. The patient was seen before, 3 years after surgery, and 9 years postoperatively. The authors reported that she gained 12 kg of weight after surgery, but she evidently lost weight later on. The images have been matched in size and orientation using the Canfield Scientific (Parsippany, NJ) Mirror Imaging software, thereby correcting the relative magnification of the original postoperative photographs. An upper arm length of 32.5 cm was used for calibration. Both upper-pole projection and breast projection are maintained at long-term follow-up. However, the lower pole has dropped 3.0 cm and is 1.2 cm lower than its preoperative level. The authors reported an increase in lower-pole distance of 4 cm between 3 years and 9 years after surgery. Adapted from Hamdi et al.16Movassaghi1 compared a series of patients treated with polydioxanone mesh (DuraSorb, Integra LifeSciences, Princeton, NJ) with a series published by Adams et al23 using poly-4-hydroxybutyrate (P4HB) mesh (GalaFLEX, BD, Franklin Lakes, NJ). Both series found a 12% average increase in the N-IMF distance at 1 year. Movassaghi1 believes that polydioxanone mesh may be the better choice because it dissolves completely in less than 1 year compared with over 18 months for P4HB. No controls were evaluated. By comparison, Ahmad and Lista,24 in a study of vertical breast reductions (without mesh), reported a significant 0.4 cm decrease in N-IMF distance at 4-year follow-up. This finding is a testament to the efficacy of the cinching effect achieved by approximating vertical pillars. A measurement study with 10-year follow-up confirmed a long-term improvement in ptosis after vertical mammaplasties, with or without implants, and no mesh.25 Movassaghi1 presented an intraoperative photograph of an augmentation/mastopexy patient treated with excision of the lower-pole parenchyma. He inserted mesh at the bottom of the wound. This material would be located very close to the breast implant. The fate of the mesh applied to the base of this wound is unknown. The product would be compressed from side to side as the pillars are approximated. It is unclear how such a material would improve wound strength. Systematic reviews have consistently reported a lack of evidence of efficacy.7,26,27 Despite claims that mesh can prevent bottoming out,9 no publication shows reliable evidence of a reduced tendency to develop recurrent ptosis.26 A 2022 systematic review concluded that implanted mesh does not prevent recurrent ptosis and bottoming out after mastopexy.27 A 2025 review found no role for mesh in cosmetic breast surgery.26 Recently, Wong and Hamilton7 evaluated 31 publications. Most studies were retrospective and uncontrolled. Sample sizes were often small. Photographs were not standardized, confounding measurements. The authors concluded, “the evidence is insufficient to recommend the routine use of mesh in aesthetic breast surgery.”7 A recent measurement study showed no benefit in breast projection or upper-pole projection in patients who received mesh.5 Photographic Integrity and Measurements To properly evaluate a mesh, some prerequisites are needed. The first is standardized photographs.5,7 Although the importance of standardized photographs is well-known,28 publications almost invariably include photographs favoring the postoperative image (Fig. 1).29 Frequently, the postoperative image is magnified relative to the preoperative photograph and/or the patient is tilted slightly.5 The second requirement is an accurate method to quantify changes in breast morphology. Linear distances measured between the sternal notch and the nipple, and between the nipple and the inframammary fold (which is often hidden in photographs), are inadequate to properly represent breast shape and quantify change.5 One-dimensional measurements, obtained by hand using a tape measure, are antiquated.5 N-IMF distances are not an adequate surrogate for the lower-pole level.5,30 This author has successfully used a 2-dimensional measurement system30 to study changes in breast shape among his own patients and also in published photographs.5 An advantage of this computer-assisted method is the ability to match photographs and measure important parameters. These parameters include breast projection, upper-pole projection, and lower-pole level. Photographs of patients treated with and without mesh are compared in Figures 1 and 2. When measurements are applied to studies supporting mesh, the claims of superiority do not hold up.5,29,31–33FIGURE 2: A–C, This 55-year-old woman underwent a vertical breast reduction using a medial pedicle and no mesh, performed by the author. The right resection weight was 360 g. She is seen before, 1 year, and 10 years after surgery. The upper-pole projection and breast projection are well maintained. The nipple remains at the apex of the breast. Over a period of 9 years, the lower pole level descended by 1.4 cm. It remains 2.8 cm above its preoperative level.Another requirement is a control cohort. Such comparison groups are missing from almost all studies endorsing mesh.26 Williams et al26 conclude that, without such comparisons, it is impossible to determine whether cosmetic outcomes are improved by mesh. Only 1 study included such a comparison, the study by József et al,22 finding a 0.25 cm difference that is likely nonsignificant.26 The last requirement is photographs taken at least 1 year after surgery to assess changes in the lower pole (ie, bottoming out) over time.25 Clearly, if mesh does not offer an advantage in maintaining and supporting the lower pole (Fig. 1), its intrinsic tensile strength is irrelevant.31 Conflict of Interest Conflict of interest is a common theme in the evaluation of studies of mesh and ADM.5,29 Many investigators have financial relationships with the manufacturer. Financial conflicts are not always disclosed.5 All 8 authors of a recent study endorsing P4HB mesh were compensated by BD, the manufacturer of GalaFLEX.9 This company also has a financial partnership with the Aesthetic Society.34 In a 2022 systematic review, Atiyeh et al27 used the Cochrane Tool to Assess Risk of Bias in Cohort Studies. In addition to marked heterogeneity, a lack of well-defined endpoints, and poor outcome measures, the authors documented inherent bias arising from potential conflicts of interest, resulting in a low level of evidence. Similarly, in their 2025 review, Wong and Hamilton7 emphasized the prevalence of commercial bias. Conflicts of interest between the authors and mesh manufacturers were reported in 18 studies (58%).7 Authors of these 18 studies were either shareholders or received financial gain from the utilization of mesh. The reviewers believe that such relationships affect investigators’ perception of efficacy and mesh use in aesthetic breast surgery (ie, confirmation bias). By contrast, authors of reviews that did not find reliable evidence of efficacy were free of financial conflicts with manufacturers.5,7,26,27 The appropriateness of asking patients about their financial condition and ability to afford an additional fee for mesh is questionable.35 Scientific journals are not commercial forums. Professional ethics and antitrust law discourage physicians from discussing or coordinating fees in ways that could influence market pricing or facilitate price-fixing rather than improve patient care.35 Patients trust their surgeons to give them the best advice, independent of financial pressures. As plastic surgeons, we need to be good stewards of our patients’ finances5 and protect them from needless and costly products. Exaggerated Claims A “bioengineered” breast implies that a breast has been created, reconstructed, or regenerated using biotechnology. Maxwell and Gabriel2 coined the term to describe the insertion of ADM in breasts. Biotechnology is defined as the application of biological organisms, systems, or components of living things to develop or modify products for practical purposes.36 Medical examples include vaccine development and recombinant DNA technology. Whether insertion of a processed allograft or a synthetic mesh qualifies as a bioengineered breast is open to question. Measurements do not confirm that such materials truly function as a “scaffold” or “internal bra.”5,29,31,32 Nevertheless, the term “internal bra” has entered common usage. Patients often ask plastic surgeons today whether they offer an “internal bra.”5 It is not a new or emerging concept. Inserting permanent and dissolving products in breasts has been tried for 45 years,37 with no reliable evidence of efficacy.5,29 A recent publication introduced the term “antigravity flap”38 to describe an operative technique that, according to the description, effectively counteracts gravity's force. Not surprisingly, measurements are unsupportive.39 This report joins a very long list of mastopexy publications19,21 and presentations1 that describe the authors’ technique for preventing bottoming out using a variety of often complex tissue transpositions, memorably labeled “cabinet-making fantasies” by McKissock.40 Responsibilities to Our Patients Setting realistic expectations for patients is not just sound medical practice; it is essential. Our professional code of ethics41 prohibits making exaggerated claims to our patients. Because they are not FDA-cleared for this indication, manufacturers are unable to mention using their products in human breasts in their marketing materials or on their websites.42 Ironically, the standard for advertising is evidently higher than the standard for scientific publications and presentations. Reviewers and editors have a responsibility to safeguard the public by vetting manuscripts to be sure they meet the standards of evidence-based medicine.6 Opposing or contradictory evidence should not be omitted in discussions and in references.5 Plastic surgery journals are intended to serve as scientific forums, not as marketing tools for manufacturers. By adopting a vertical mastopexy and augmentation/mastopexy technique,12 surgeons can provide effective, consistent, and durable results that are supported by long-term measurements.25 The requirements for a sound scientific basis and reliable evidence of efficacy6 are satisfied. CONCLUSIONS No reliable evidence supports the insertion of any product at the time of cosmetic breast surgery, including synthetic mesh.5 These products have not been cleared for any application in breast surgery.42 Plastic surgeons and patients need to be wary of the financial influence of manufacturers.7 Plastic surgeons may function as independent investigators or highly compensated consultants, but not both.43 In making the case for mesh, Movassaghi1 showed a slide of a building standing on a faulty foundation. Ironically, any role for mesh in cosmetic breast surgery does not have sound scientific underpinnings. Mesh should not be described as a scaffold or an internal bra. These marketing terms can mislead patients regarding their capabilities.5 Unfortunately, in plastic surgery, commerce often takes precedence over science.5,29 Innovation is championed while rigorous science takes a back seat.29 Part of our responsibility as physicians is to apply our knowledge and training to separate the wheat from the chaff. Surgeons must resist the temptation to adopt a new product solely on marketing grounds.29 The old adage applies: everything good was once new, but not everything new is good.