Implant-based breast reconstruction and augmentation

INTRODUCTION — 

Modern breast reconstruction began in 1964 with the introduction of the silicone breast implant. Since that time, implants have evolved, although the basic components have remained essentially unchanged. Implants themselves can be filled with either saline or silicone gel.

Breast implants are used either for reconstructive or aesthetic (cosmetic) purposes.

●Implants can help restore the breast to normal appearance following a unilateral or bilateral mastectomy for patients with breast cancer or following risk reduction surgery. Reconstruction can be performed immediately after the mastectomy or delayed. Implants may also be used for the reconstruction of congenital or traumatic defects and for the management of significant asymmetries.

●Aesthetic uses for implants improve an otherwise normal breast and include breast augmentation, and, less commonly, implants can be used together with a mastopexy.

The prosthetic devices available for reconstruction, choice of procedure, timing, and surgical techniques of implant-based reconstruction will be reviewed here. The use of tissue flaps and grafts for reconstruction is reviewed separately. (See "Overview of breast reconstruction" and "Options for autologous flap-based breast reconstruction".)

BREAST PROSTHESES AND OTHER DEVICES — 

Breast implants are composed of an outer silicone shell that is either filled with silicone gel at the time of manufacture or filled with saline by the surgeon at the time of implant placement or by the manufacturer at the time of creation [1].

Implant-based breast reconstruction has resumed a major role in breast reconstruction with the improvement and reapproval of silicone gel implants and the use of acellular dermal matrix (ADM) to assist with coverage and positioning. Developments have restricted the use of certain textured surface devices in the United States, including Biocell surface implants and polyurethane. In addition, the US Food and Drug Administration (FDA) has emphasized that the use of acellular dermal matrices in the breast is off-label [2].

Few studies have compared different types of implants. A systematic review included five trials [3-7], each comparing different features of implants, and concluded that the studies were of low quality and of a high risk for bias [8]. As such, following a candid discussion regarding the potential issues involved with each type of implant, surgeons should use the implants for which they have obtained good results.

Types of implants — Implants and tissue expanders are available in an array of different widths, heights, and projections. Saline-filled and silicone gel-filled breast implants with a silicone shell are predominantly used in the United States; however, other types of implants (eg, polyurethane shell, double-lumen implants) are no longer available but have been used previously in the United States and elsewhere. The surface of the breast implants can be smooth or textured. Smooth implants have predominantly been used in the United States, and textured implants have predominantly been used in Europe and South America. Textured surface implants have captured the attention of the scientific community and the media because of their association with anaplastic large-cell lymphoma. (See "Breast implant-associated anaplastic large cell lymphoma".)

Due to the increasing concerns associated with some of these textured surface breast implants, the sale and distribution of certain textured surface devices has ceased in the United States and many European and South American countries [9]. (See 'Anaplastic large cell lymphoma' below.)

Other features of breast implants include:

●Number of compartments:

•Single-lumen implants.

-Silicone gel implants have an outer silicone shell but are prefilled at the time of manufacture. The composition of the outer silicone shell and the silicone gel material have been modified over time to improve implant performance. Further subtypes for these implants are based on the qualities of the gel. The later-generation devices are composed of a more cohesive silicone gel that is less likely to deform and may provide a more favorable shape and appearance to the breast.

-Saline implants also have an outer silicone shell and are filled with saline by the surgeon at the time of implant placement but may also be ordered in the prefilled variety.

•Double-lumen implants have two separate compartments; one is prefilled with silicone gel, and the other is filled with saline. In some models, the surgeon can adjust the saline volume. Both combinations of filler material in each lumen are produced with either silicone in the outer lumen with saline in the inner lumen or saline in the outer lumen with silicone in the inner lumen. The complications associated with these implants are similar to those seen with both saline and silicone implants. Double-lumen implants are not commercially available in the United States.

●Shape:

•Round with a symmetric, disk-like shape.

•Nonsymmetric implants (also called "teardrop" or "anatomic") with more projection at the inferior pole.

•Each of the shape types may be available in different implant diameters, projections, volumes, and implant-height-to-implant-projection ratios (eg, high profile, moderate profile).

●Shell surface:

•Smooth silicone shell.

•Textured silicone shell.

It is important to note that all currently available implants in the United States have a shell surface that is made of silicone, regardless of whether it is filled with silicone gel or saline. A smooth silk surface implant was approved for use in the United States after it had completed its six-year trial and demonstrated low complication rates following breast augmentation surgery [10].

Implants that have been removed from use include:

●Biocell surface implants – These implants are manufactured by Allergan and were voluntarily recalled in 2019 due to the association with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It should be noted that smooth surface devices have not been linked to BIA-ALCL and remain available for breast reconstruction and augmentation in the United States.

●Polyurethane implants – These silicone gel-filled implants were coated with a polyurethane shell that resulted in significantly lower capsular contracture rates [11]. However, concerns were raised about the possible toxicity of the degradation of polyurethane toluene, and these implants were removed from the United States market in the early 1990s; however, they remain widely available worldwide. Surgeons should be aware that removal of these implants can be challenging due to the lack of a defined surgical plane between the implant and surrounding tissue. This may result in more intraoperative bleeding, excess breast tissue removal, and difficult postexplantation reconstruction [12].

●Trilucent implants – These were filled with a radiolucent medical-grade triglyceride filler (eg, soybean oil) that was claimed to be biodegradable and with easily excreted byproducts. These implants were associated with high complication rates [13]. They were removed from the market in 1999 due to leaking of the filler, shell deterioration with a loss of texture, extreme fragility of the implant with frequent ruptures, and a pronounced inflammatory reaction [14].

●MISTI gold polyvinylpyrrolidone-hydrogel-filled implants – These were used in the 1990s as an alternative to silicone-filled implants with claims of improved radiolucency and gel biocompatibility. Unfortunately, subsequent reports showed that the implants increased in volume over time (an average of 43 percent) and had high rates of capsular contracture [15].

Tissue expanders — The first stage of implant-based breast reconstruction often includes placement of the tissue expander. Procedural statistics from the American Society of Plastic Surgeons from 2022 demonstrate that nearly 69.9 percent of prosthetic breast reconstructions are performed in two stages, using a tissue expander first [16]. A tissue expander is a silicone shell that is incrementally filled with saline through a port that is either integrated or remotely located. In some situations, the surgeon may choose to fill the tissue expander in the operating room with air, although this is technically considered an off-label approach. This is sometimes considered for tissue expanders placed in the prepectoral position because it is light and evenly distributed within the expander. When air is placed, it is typically removed two weeks following insertion and replaced with saline. The reason for replacement is that under increasing pressure, air will dissipate out of the expander, whereas saline will not. Once the appropriate breast shape has been reached, the expander is removed and replaced with a silicone gel or saline implant.

Many expander options are available, such as expanders that are crescent-shaped, only expanding as a lower pole of the new breast, as well as differential expanders stretching the lower pole more than the remaining breast shape. Many tissue expanders have suture tabs located along the peripheral base of the device to accurately place and stabilize its position on the chest wall. All manufacturers offer smooth surface tissue expanders, as these devices have become more commonly used due to the concerns associated with textured surface devices [17]. The majority of tissue expanders that are currently available on the market are filled incrementally with saline. A tissue expander that received US FDA clearance was incrementally and automatically filled with carbon dioxide [18]; however, the company filed for bankruptcy in 2019, and these carbon dioxide-filled tissue expanders are no longer available.

Tissue expanders all have metallic components that are necessary for the safe localization of the port for filling and expansion. Magnetic resonance (MR) imaging is necessary at times in patients with tissue expanders; however, safety concerns have been raised due to pain, burning sensation, and possible subsequent port dysfunction. Strategies to minimize these risks include using 1.5T MR imaging, device selection, filling expanders with saline, and prone positioning during MR [19]. A tissue expander that is reportedly MR imaging-compatible and is available in the majority of countries, including the United States [20].

One to three weeks after the air or saline-based tissue expander is placed, in-office expansion begins. For expanders with integrated ports, a magnetic finder (compass) is used to locate the proper injection site under the skin. For patients in whom air was used as the intraoperative filler, a needle is inserted through the skin and into the port, and the air is evacuated, followed by the instillation of sterile saline into the expander. Saline is preferred for expansion because air has a tendency to dissipate through the expander shell as the pressure increases. For patients in whom saline was instilled intraoperatively, additional saline is instilled. This procedure is repeated every one to two weeks until the desired volume of expansion has been achieved. Tissue expander filling should be stopped during the phase of radiotherapy delivery. In some situations, temporary deflation of the expander may be requested to allow for adequate delivery to the chest wall and internal mammary lymph nodes. (See "Overview of breast reconstruction", section on 'Integrating radiation therapy and breast reconstruction'.)

Following the final expansion, usually two to three months in patients who do not need radiation, the patient is returned to the operating room for the second stage of the reconstruction. For patients who do require radiation therapy in the setting of a tissue expander, the exchange usually occurs three to six months following radiation. The expander is removed, and a permanent implant is usually placed, although flap reconstruction is also a consideration at this stage in patients who have been radiated. Additional revisions, such as fat grafting and repositioning of the implant, can be performed at this time. In some cases, nipple reconstruction can be performed at this stage, but more commonly, it is performed at a later time. Rather than using an anatomic nipple reconstruction, many surgeons use three-dimensional tattoos for nipple-areola reconstruction. (See "Overview of breast reconstruction", section on 'Adjunctive procedures'.)

Acellular dermal matrix and other meshes — The use of acellular dermal matrices (ADMs) from allograft (human cadaveric) or xenograft (nonhuman) sources has broadened the options for prosthetic reconstruction following mastectomy [21-23]. (See "Skin substitutes".)

The ADM is supplied as a sheet of decellularized material consisting primarily of collagen and elastin. ADM is meant to serve as biologic scaffolding for fibroblast and angioblast ingrowth and, over time, is replaced by host connective tissue at varying rates. ADM has general approval in the United States for "homologous use" for soft tissue support. Although ADM has been widely used for breast reconstruction since 2005, specific use within the breast is considered off-label in the United States. While surgeons can use it in the breast, a thorough discussion between the patient and surgeon to review the benefits and risks should happen before the surgery takes place [24]. (See 'Procedure selection and staging' below.)

In a communication from March 2021 [25], recommendations for patients and caregivers were published and included:

●Before surgery, the patient should discuss the benefits and risks of implant-based breast reconstruction with and without ADM use. If ADM will be used, the type of ADM should be discussed with the provider.

●Be aware that although ADM is used for other types of reconstruction, the use of ADM is considered "off-label" for use in breast reconstruction.

●Be aware that reoperation or removal of implanted ADM as a preventive measure is not recommended.

●If a patient has had breast reconstruction with ADM and experiences a problem, filing a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program, is encouraged [26].

The principal use of ADM in breast reconstruction is to provide adequate tissue support to the mastectomy skin flaps. In cases where the tissue expander or implant is positioned partially under the pectoralis major muscle, the purpose of the ADM is to stabilize the position of the pectoralis major muscle to prevent upward migration of the muscle, also known as "window shading." In cases where the tissue expander or implant is positioned above the pectoralis major muscle (ie, prepectoral reconstruction), the ADM is used to line the inner aspect of the entire mastectomy skin flap to provide additional soft tissue support [27]. ADM can be used for both one- and two-stage prosthetic reconstruction [28].

Other mesh products, such as poly-4-hydroxybutyrate and polyglactin, can also be used in prosthetic breast reconstruction settings [29]. Results with these products have been mixed with regard to clinical outcomes. These mesh products are also considered "off-label" for the breast.

CONCERNS OVER BREAST IMPLANTS

Breast implants and systemic illness — Anecdotal reports initially raised the question of a possible association between silicone gel implants and various systemic diseases (in particular, connective tissue diseases) or a "silicone adjuvant syndrome." This spectrum of symptoms has also been referred to as breast implant illness (BII). When confronted with patients with symptoms suggestive of BII, health care providers should not be dismissive but rather explanatory and empathetic, providing reassurance that their complaints are valid [30]. In symptomatic patients, imaging of the breast should be performed periodically; however, if the patient wants the implants removed, then explantation should be considered. In the absence of disease, capsulectomy, which can be partial, total, or en bloc, is controversial, and patients must be educated about the differences [31]. It is important to emphasize to patients with systemic symptoms that "en bloc" capsulectomy is reserved for patients with documented malignancy; it is not recommended or advised for patients without cancer.

In response to concerns and controversy surrounding silicone gel breast implants, the US Food and Drug Administration (FDA) and the Institute of Medicine (IOM) reviewed the available information and literature on breast implants [32,33]. In their initial review in 2006, the FDA concluded that other than surgical or implant-related local complications that may or may not result in reoperation, the available evidence did not support a relationship between breast implants and systemic illness. Based on epidemiologic studies, the IOM concluded in 1999 that there was no association between silicone gel breast implants and connective tissue disease [32,34-44]. However, the available studies may have been underpowered to demonstrate such an association. Given the ongoing controversy surrounding breast implants and the fact that there is a large cohort of women who assert they have BII, the FDA is re-reviewing the evidence surrounding this complex issue. Some studies have suggested that BII may represent an allergic process related to breast implants; however, confirmatory studies are lacking [45]. Clearly, ongoing study on a possible relationship will be important. It remains possible that certain women, particularly those with preexisting allergies, may be predisposed to immune-mediated reactions to medical device materials [46].

Despite concerns over BII, previous studies have failed to demonstrate an association. Systematic reviews from 2000, 2007, and 2016 concluded there was little or no basis for any association between breast implants or implant rupture and connective tissue disease [37,43,44]. A later comprehensive review evaluated the risk of connective tissue disease, other rheumatic disorders, and other self-reported symptoms in patients with breast implants from 86 studies [47]. The review succinctly summarized the challenges in trying to determine causation between breast implants and these disorders. The authors concluded that "overall, there remains much uncertainty in regard to the association between breast implants and the risk of incident rheumatic diseases," but "based on a small number of high-quality studies, an association between breast implants and a small increase in scleroderma or rheumatoid arthritis could not be excluded." Importantly, among studies evaluating symptoms following the removal of breast implants, the authors noted that it was unclear whether the benefit attributed to explantation was due to the removal of the breast implants versus the concomitant use of glucocorticoids or other immunosuppressive drugs, the natural history of the disease, or a placebo effect.

A 2019 study that gained prominence evaluated data prospectively collected by the FDA from large postapproval studies, which together represented almost 100,000 women (Allergan, Mentor Corp) [48]. Their findings showed a higher rate of Sjögren's disease, scleroderma, rheumatoid arthritis, stillbirth, and melanoma when compared with normative data. However, limitations to this study, which are common to many other studies of this issue, included:

●The study was a secondary analysis of summarized data without access to the methodology or raw data.

●There was a significant loss to follow-up. The analysis was limited to <34,000 of the 99,993 total patients, which introduced a study bias and limited the interpretation of the study results.

●Patient-reported outcomes were mixed with physician-reported outcomes. The Mentor data were patient-reported, whereas the Allergan data were physician-reported.

●The analysis was not adjusted for potential confounding factors, and the results were also not consistent between implants of the same type from differing manufacturers.

Studies continue to investigate the associations between breast implants and systemic symptoms [49]. These have demonstrated that although removal of the breast implant can reduce symptoms, the improvement is independent of whether the capsule is removed totally, partially, "en bloc," or not at all [50].

Implant-associated malignancy — The future possibility of rare implant-associated malignancies such as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), breast implant-associated squamous cell cancer (BIA-SCC), and other lymphomas needs to be considered when counseling patients. (See 'Counseling and informed consent' below.)

Anaplastic large cell lymphoma — In 2011, 2016, 2017, and 2019, the FDA issued reports on the association between textured breast implants and a rare cancer, anaplastic large cell lymphoma (ALCL) [51]. An FDA advisory panel convened in late March 2019 to discuss various issues related to silicone gel breast implants, which included ALCL, breast implant illness, and acellular dermal matrices. In July 2019, the FDA requested a recall of certain textured breast implants [52]. This was based on data suggesting an increased association of BIA-ALCL with the BIOCELL surface implants (Allergan), including permanent implants as well as tissue expanders. The FDA does not recommend breast implant removal for asymptomatic women who already have this type of implant. The recall does not include smooth surface devices that use either saline or silicone gel as the filler material. (See 'Types of implants' above.)

A systematic review of BIA-ALCL concluded that this form of ALCL clinically behaves more like the less aggressive primary cutaneous form of anaplastic lymphoma kinase (ALK)-negative ALCL rather than the more aggressive systemic form but that further research is needed to better understand its nature [53]. In 2016, BIA-ALCL was provisionally recognized by the World Health Organization and standardized diagnosis and treatment guidelines established by the National Comprehensive Cancer Network (NCCN) [54]. BIA-ALCL is discussed in more detail separately. (See "Breast implant-associated anaplastic large cell lymphoma".)

Squamous cell carcinoma — BIA-SCC has been reported in the capsule surrounding the breast implant (textured or smooth, saline or silicone) [55-57]. In a communication from the American Society of Plastic Surgeons (ASPS), they noted the occurrence of 400 cases of suspected or confirmed cases of BIA-SCC in the United States, which was more than reported to the FDA through postmarket review [58-61]. Like BIA-ALCL, BIA-SCC can present with late-onset seroma or mass. The limited experience with BIA-SCC suggests that it is an aggressive pathology [55]. Mortality is 43.8 percent at six months, which contrasts with BIA-ALCL, which has a mortality rate of 2.8 percent at one year [60]. The average length of time from implantation to BIA-SCC occurrence is 22.7 years (range 11 to 40), which is longer compared with BIA-ALCL. BIA-SCC can occur in association with either smooth or textured surface implants, whereas BIA-ALCL is primarily associated with textured surface implants. (See "Complications of reconstructive and aesthetic breast surgery", section on 'Squamous cell carcinoma and B cell lymphoma'.)

Other malignancies — A systematic review of the relationship of silicone breast implants to other cancers concluded [62]:

●Epidemiologic studies provide no support for an increased risk of either sarcoma or multiple myeloma among breast implant recipients, disputing clinical and laboratory findings suggesting such a link.

●Although some epidemiologic studies have demonstrated elevated risks of cervical, vulvar, and lung cancers among breast implant patients, it is likely that these relate more to lifestyle characteristics (eg, cigarette smoking, sexual behavior) than to the effects of the implants.

●Brain cancer risk, suggested in one study, has not been confirmed in either an update of the mortality experience in this study or on the basis of any other investigations.

●At present, there is no convincing evidence that breast implants alter the risk of these specific nonbreast malignancies.

PROCEDURE SELECTION AND STAGING — 

Patients should be offered choices for reconstruction that fit their lifestyle, are congruent with the available local tissue, and help to match the opposite breast. Although there is some evidence in the existing literature that favors autogenous tissue reconstruction over implant reconstruction based on long-term (greater than five years) outcomes [63-69], implant-based reconstruction will always have a role in breast reconstruction. It would be unwise to offer an autologous reconstruction solely to avoid the use of an implant since it is not absolute that autologous tissue reconstruction will never require an implant. Fat necrosis or weight changes may result in a smaller-than-desired breast mound, and an implant may be required to achieve goals or symmetry. Moreover, the use of some autologous tissues (eg, latissimus myocutaneous flap) usually requires an implant for completion. In a review of 96 patients, the incidence of complications was increased when the implants were placed immediately rather than on a delayed basis [70].

●The advantages of implant-based reconstruction are that it is technically a simpler operation to perform, the use of cosmetically similar adjacent tissue to cover the implant, the lack of donor site morbidity, reduced operative time, and more rapid postoperative recovery compared with purely autologous reconstructions [71,72]. For older patients, those with significant medical comorbidities, and women with minimal tissue at the various potential donor sites (abdomen, buttock, back, and thigh), expander/implant-based techniques may be the preferred option. The best candidates have minimal ptosis (breast sag), a moderate breast volume (500 g or less), and adequate soft tissue for coverage; however, studies have demonstrated success in a variety of body types, including patients who are obese [73].

●The disadvantages of implant-based reconstruction include more difficulty obtaining symmetry to the normal opposite breast, a larger number of stages to achieve completion, difficulty when the breast has been irradiated, and implant visibility, rippling, and palpability concerns in thin patients and in patients with thin mastectomy skin flaps. Tissue expansion requires frequent clinic visits for expansion (usually every one to two weeks for one to two months) and a second surgery to place the reconstructive implant. The use of acellular dermal matrices (ADMs) can improve results in very thin patients or a patient with contour irregularities postmastectomy. For women who require postmastectomy chest wall radiation therapy, tissue expansion can be a difficult and complication-prone endeavor. In these cases, autogenous tissue (flap) reconstruction is often preferred [74]. While many surgeons can reconstruct an irradiated chest with implant expander reconstruction, others will reject tissue expansion and implant reconstruction in this group, relying more on vascularized autologous tissue. (See "Overview of breast reconstruction", section on 'Integrating radiation therapy and breast reconstruction'.)

Goals should include not only the size (presumably matching the opposite breast, whether reconstructed or otherwise) but also shape issues such as cleavage and projection (eg, high profile with a more rounded appearance, moderate profiles with adequate projection but possibly increased width). The implant reconstruction is chosen by assessing skin coverage, thickness, and suitability for expansion. Further evaluation assesses pectoralis muscle quality and determines the need for an ADM graft. Size and shape goals then dictate the number of stages and courses, often consisting of one or two outpatient procedures. The variety of available implants, both silicone and saline, with the adjunctive use of ADM to facilitate coverage and shape, can fulfill almost every patient desire and goal.

The informed consent for breast augmentation and reconstruction should include the nature of the surgery, indications, benefits, consequences, and potential complications of the procedure. In addition, consent should include alternatives to the procedure and the benefits, risks, and consequences of the stated alternatives. It is now recommended that all women receiving breast implants be informed about the risks associated with implant-associated anaplastic large-cell lymphoma [75]. (See 'Informed consent' below.)

Procedure staging — Implant-based breast reconstruction can be accomplished either as a one-stage procedure (primary reconstruction, direct-to-implant reconstruction) or as a two-stage procedure (secondary reconstruction). With a one-stage procedure, the breast implant is placed beneath the mastectomy skin flaps or, in some cases, beneath the pectoralis major muscle. With a two-stage procedure, the placement of a permanent breast implant is preceded by the placement of a tissue expander, which stretches the existing soft tissue to cover the new breast (figure 1). Most plastic surgeons in the United States prefer the two-stage technique because the second stage provides an opportunity to optimally shape and configure the reconstructed breast by adjusting the implant pocket, selecting an appropriate permanent implant, and releasing periprosthetic scar tissue. Regardless of the technique selected, there should be a thorough and complete discussion with the patient and insurance company representative to ensure that the procedure and all potential revisions that may be needed are covered.

Whenever there is a skin deficiency or questionable viability of the skin, tissue expanders or delayed reconstruction should be considered for the reasons mentioned above. Women with large ptotic breasts may require more skin excision during the mastectomy, and therefore, they need more expansion. Such women may also require a contralateral breast procedure, such as breast augmentation, breast reduction, or mastopexy (breast lift), to achieve acceptable symmetry. (See "Overview of breast reconstruction", section on 'Adjunctive procedures'.)

One-stage reconstruction is typically offered only to women who have ample skin following the mastectomy. Women with small, nonptotic breasts can often be reconstructed in a single stage (picture 1). One-stage reconstruction may also be possible in patients who have been previously augmented because the skin and soft tissues are pre-expanded, and the contralateral augmented breast is usually already well-matched with an implant (picture 1). Skin-sparing and nipple-areolar-sparing mastectomy may allow consideration of the one-stage option, although revisions are sometimes necessary. It is important to appreciate that a one-stage operation does not imply a single operation. Breast implants are not lifetime devices, and secondary revisions are relatively common over time [76].

Another consideration is the possible need for radiation treatments and chemotherapy. Many radiation oncologists will not accept the presence of an implant during radiation treatments. Further complicating a choice for one-stage reconstruction is frequent insurance coverage interference with any subsequent revision or adjustment. By approving a "one-stage" reconstruction, coverage for revisions might be precluded. This is particularly important considering that a one-stage procedure may be associated with a higher rate of complications compared with a two-stage procedure. In a trial that randomly assigned 59 patients (91 breasts) to one-stage implant-based breast reconstruction with acellular dermal matrix or a two-stage reconstruction, the one-stage procedure was associated with more complications (36/91 versus 13/92 reconstructions) and increased short-term costs [77]. The difference in reported complications was significantly increased for bilateral one-stage versus two-stage breast reconstructions (24 versus 9 reconstructions).

COUNSELING AND INFORMED CONSENT — 

Discussion of two specific safety concerns are considered mandatory and include breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and complexes of symptoms known as breast implant illness [78]. (See 'Concerns over breast implants' above and 'Informed consent' below.)

Breast implants should not be placed in women with active infection anywhere in their body, women with breast cancer who have not received treatment, or women who are currently breastfeeding. The safety and efficacy of breast implants have not been established in women with autoimmune disorders, compromised immune function, and in those with risk factors for impaired wound healing. Women with a history of depression or mental health issues should hold off until stabilization or resolution of psychological symptoms prior to considering the placement of breast implants.

Potential future issues

Breastfeeding — Implant-based breast augmentation should not interfere with breastfeeding if it is desired. In a review of 4679 individuals who gave birth at least once after primary augmentation (total of 5736 live births), 79 percent breastfed at least one child [79]. The rate of lactation complications was similar to that of the general population of women who breastfeed and was comparable for silicone and saline implants. The most common complication was insufficient milk production. Nevertheless, rates of breastfeeding may be lower in those with breast implants [80,81].

The possibility of implants affecting breast milk was addressed in studies comparing silicone levels in breast milk from women with or without silicone gel breast implants and also compared with levels in commercially available milk and infant nutritional formulas [82,83]. Mean silicone levels were not significantly different in breast milk from women with and without implants (55 versus 51 ng/mL). Furthermore, these levels were much lower than the mean silicone levels measured in store-bought cow's milk (708 ng/mL) and those from commercially available infant formula (4402 ng/mL).

Breast cancer detection — Because of conflicting reports, a potential concern related to implants used for breast augmentation is the potential interference with breast cancer detection and the possible risk of developing breast cancer. Fortunately, potential patients may be advised that augmented patients are not at greater risk than the nonaugmented population for developing breast cancer, and early detection of occult cancer is possible in augmented patients [84]. The current recommendations for screening are no different for augmented patients, although ultimately, the decision lies with the surgeon and patient. Recommendations for post-treatment surveillance of the reconstructed breast (with or without implants) are discussed separately. (See "Overview of breast reconstruction", section on 'Surveillance of the reconstructed breast'.)

Characteristics of breast imaging differ depending upon the type of implant (saline, silicone gel) and type of imaging because of differences in the structures of the materials (ie, density, atomic number, electron density). In an experimental study comparing the mammography appearance of six different implant fillers, the poorest visualization was through silicone gel [85]. On magnetic resonance (MR) imaging, silicone gel appears as a high-intensity material, while saline appears as a low-intensity material [86]. With ultrasound, there may be differences in echogenicity between silicone gel and saline; however, gel echogenicity is not a criterion that is used to determine implant integrity [87].

Despite differences in the radiographic properties between saline and silicone gel implants and improved imaging for submuscular compared with subglandular placement, specialized techniques can be used to facilitate the ability of the breast imaging specialist to visualize the breast tissue. Eklund views (displacement techniques) should be used when obtaining mammograms in augmented patients and should be interpreted by radiologists experienced in the evaluation of augmented patients.

One series of patients from a prospective database consisting of 3953 nonaugmented and 129 augmented breast cancer patients found that augmented and nonaugmented patients were diagnosed at a similar stage and had a comparable prognosis [88]. The authors concluded that while implants may impair mammography, they appear to facilitate the detection of palpable breast cancers on physical examination.

Informed consent — For all breast operations using a prosthetic device (implant or tissue expander, augmentation, or reconstruction), the patient needs to be carefully selected and counseled prior to undertaking these procedures. In the United States, a mandate requires that surgeons review a patient decision checklist with all prospective patients considering breast implants. In a communication from October 2021 [89], extended recommendations were made for patients and caregivers regarding patient counseling and informed consent prior to the use of breast implants. These included:

●A boxed warning on all breast implants.

●A "Patient decision checklist" that must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits, and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist, and it must be signed by the physician implanting the device.

●Updated silicone gel-filled breast implant rupture screening recommendations. (See 'Imaging following implant placement' below.)

●A Device description with a list of specific materials in the device.

●Patient device card.

Patient counseling should also include a discussion of all options for implant-based reconstruction, potential complications, the need for multiple surgeries and revisions, and a realistic discussion about patient expectations. Even when reconstruction is completed, future revisions or implant replacement may be needed for laxity, stretch, and aging. The boxed warning provided for all breast implants emphasizes that these are not lifetime devices; complications can occur, and textured surface devices have been associated with the development of anaplastic large-cell lymphoma. (See 'Implant-associated malignancy' above.)

When acellular dermal matrix or surgical mesh is used in conjunction with a breast implant, patients must also be informed that any surgical mesh product placed in the breast is considered "off-label." This does not mean that acellular dermal matrix (ADM) cannot be used when necessary, but it does require that patients be fully informed. The benefits and risks of ADM are reviewed above. (See 'Acellular dermal matrix and other meshes' above.)

Implant-based breast reconstruction should be discussed with all patients seeking breast reconstruction. Patients with medical issues or who refuse larger, more complicated surgeries should be presented with the pros and cons of implant-based breast reconstruction. The wide variety of choices of implant alone, tissue expander followed by implant, and implant plus myocutaneous flap (with or without the use of ADM tissue) gives the surgeon and patient many options to choose from.

Implant-based breast reconstruction poses a greater challenge compared with aesthetic breast augmentation. In addition to attempting a symmetric result, the mastectomy adds to the difficulty of producing a supple projection with its inherent scarring and possible restriction. Furthermore, the emotional cost of a cancer diagnosis interferes with both expectations as well as final acceptance. Immediate attempts at reconstruction add further demands toward producing a "normal breast" in one or two operations. The surgeon must discuss all of these issues with the patient or be faced with an unrealistic patient expectation and, possibly, dissatisfaction with an otherwise acceptable result. The patient must understand the difficulties that can occur with breast reconstruction postmastectomy.

Complications can lead to delayed healing, and problems may result in implant removal, infection, or excessive scarring. Capsular contracture can occur and may be related to various factors, including the subclinical presence of bacteria, hematoma around the device, and radiation therapy. Implants are not designed to last forever, and many will need to be replaced at some point in the future. The need for revision to achieve symmetry must also be understood. In addition, the position of the implant can affect the glandular volume, as with subglandular positioning, or reduced volume of the pectoralis major muscle, as with submuscular positioning [90]. Rupture associated with silicone gel implants is often silent and may require studies such as MR imaging or ultrasound for detection. Rupture of saline implants is much easier to detect as the device will usually deflate within 24 hours, resulting in a noticeable change in volume. Implant rupture typically results in implant replacement. Other reasons to replace an implant are capsular contracture, ptosis, or inappropriate size and shape. Lastly, the patient's needs may change, or an improved implant may become available. If these would improve results, replacement should be made available. (See "Complications of reconstructive and aesthetic breast surgery".)

Women who are considering breast implants should have thoughtful and balanced discussions with their health care professional on the benefits and risks of breast implants based on clear information reflecting the most current understanding of their safety. Patients should be informed about the small risk of BIA-ALCL that has been associated with textured implants [91]. It is also recommended that women be informed about the possible association between silicone breast implants and breast implant illness [45]. (See 'Types of implants' above and 'Concerns over breast implants' above and "Breast implant-associated anaplastic large cell lymphoma", section on 'Informed consent prior to implant placement'.)

PREOPERATIVE PREPARATION

Preoperative markings and implant selection — Implant selection is based upon dimensional planning and should involve the patient's input. In addition, the mastectomy specimen can be used for planning, and ideally, preoperative and premastectomy evaluation can help with implant size and shape choices. Skin laxity and desired shape ultimately combine to produce the potential implant, height, width, and projection. Markings and measurements should consider the addition of an acellular dermal matrix (ADM) flap thickness. The opposite breast is also considered, as well as the presence of preoperative asymmetry; the patient should be made aware of such asymmetry and measurements. Other considerations of implant choice involve tissue coverage and thickness. Following mastectomy, patients with well-perfused tissue and adequate skin coverage may proceed with the placement of a smooth surface tissue expander or implant. In patients with thin skin or poorly perfused tissue following mastectomy, consideration for a tissue expander placed above or below the pectoral muscle should be considered. When severely compromised, immediate reconstruction should be aborted, and instead, patients should be advised to pursue delayed reconstruction. The use of textured surface devices is no longer advised in the United States. Women considering textured surface breast implants should be informed about the risk of anaplastic large cell lymphoma. Once the base width, height, and projection of the desired implant are determined, an implant can be selected from available manufacturers to produce the desired result. It is suggested that a number of implants are ordered and made available at the time of the surgery, both slightly larger and smaller than the dimensional planning size.

Prophylactic antibiotics — Although systemic antibiotics, such as cefazolin, are widely used for prophylaxis at the time of implantation, there is little high-quality evidence to support their efficacy 24 hours following the procedure [92]. Guidelines from multidisciplinary expert groups in the United States also recognize the low risk of surgical site infection with breast reconstruction or augmentation surgery and do not recommend routine antimicrobial prophylaxis (table 1), except for patients who have particular risk factors for infection, such as patients with diabetes mellitus, obesity, known colonization with microorganisms, and who are immunocompromised [93,94]. In a systematic review of surgical site infections following aesthetic breast surgery, the estimated mean incidence of postoperative surgical site infection following augmentation surgery was 1.4 percent (range 0 to 1.7 percent) [95]. No reduction in infection rates was observed with preoperative antibiotic prophylaxis usage. (See "Antimicrobial prophylaxis for prevention of surgical site infection in adults", section on 'Breast surgery'.)

If prophylaxis is given, it should cover the most common organisms responsible for wound infection, particularly staphylococci. A first-generation cephalosporin (eg, 2 g intravenously) is effective [93]. A single dose should be given 60 minutes prior to the surgical incision. The available data suggest that extended prophylaxis following implant-based breast reconstruction is unnecessary. In a randomized trial comparing two-stage breast reconstruction with and without postoperative antibiotic prophylaxis, rates of surgical site infection were equivalent for 24 hours of antibiotics compared with extended oral antibiotics [96]. However, the decision to provide postoperative antibiotics beyond 24 hours should be at the discretion of the surgeon or primary medical team. (See "Breast implant infections", section on 'Microbiology and epidemiology of infection' and "Antimicrobial prophylaxis for prevention of surgical site infection in adults", section on 'Antibiotic selection'.)

Controlled clinical trials have demonstrated the efficacy of pocket irrigation with reported lower rates of surgical site infection and capsular contracture when using an antibiotic solution or povidone-iodine, supporting what is commonly done by most plastic surgeons [97]. (See 'Antibiotic irrigation' below.)

SURGICAL TECHNIQUES — 

Implant-based breast reconstruction can be accomplished in a single stage or in multiple stages, the first stage of which involves the placement of the tissue expander. Between 1970 and 2015, the most common technique used for expander/implant placement consisted of initially positioning the device in a pocket deep to the pectoralis major muscle and overlying breast skin. Since 2015, in properly selected patients, a tissue expander may be placed in a prepectoral position, which avoids the morbidity of muscle elevation and muscular distortion (animation deformity) of the implant in the final reconstruction [27]. The benefits of this approach are that patients usually have less pain due to the avoidance of pectoral muscle disruption; there is no-to-minimal breast animation deformity with pectoral muscle contraction and a natural breast contour can be maintained.

When comparing the submuscular techniques, it should be appreciated that a tissue expander or implant can be placed completely or partially under (dual plane) the pectoralis major muscle. A more natural result may be achieved using a dual plane technique (as opposed to complete pectoralis muscle coverage), with superior and middle muscle coverage and the use of acellular dermal matrix (ADM) for coverage inferiorly to allow a more relaxed breast shape.

For traditional tissue expander reconstruction based totally or partially beneath the pectoralis major muscle, the serratus anterior muscle or fascia may be used to provide additional lateral coverage for the tissue expander. The technique of complete muscle coverage is to develop a subpectoral pocket superiorly and continue laterally with the serratus muscle as needed to obtain complete coverage. Overall, the pocket size or footprint of the breast should match the horizontal and vertical dimensions of the tissue expander. It is important not to alter or undermine beyond the normal breast borders, especially the inframammary fold, as these lower and medial borders are critical landmarks for the aesthetic appearance of the breast. If there is concern that the mastectomy flaps have compromised vascular supply, expander placement should be delayed. From an aesthetic perspective, it is more difficult to achieve a natural breast shape with complete submuscular coverage even after full tissue expansion. Further difficulty occurs if the mastectomy surgery has resulted in damage to the lower pectoralis muscle.

If the pectoralis muscle has been damaged during the mastectomy or from prior surgery, having biologic tissue available to provide coverage over an implant is important. ADM has assumed a major role in providing this soft tissue coverage. As an alternative to total muscle coverage of the tissue expander or implant, a more desirable result may be obtained by creating dual plane coverage of the device with the use of muscle in the upper two-thirds and ADM in the lower one-third. This allows for total control of the pocket, width, shape, and coverage of the implant. Although the cost of ADM is a consideration, most insurance companies will cover the costs of ADM when used for breast reconstruction. The technique uses the normal muscle in the upper portion of the chest to suture the ADM to the muscle to create a pocket both medially and laterally. An expander or implant can then be placed beneath this combined muscle ADM cover, either with or without the need for expansion. It is common to need prolonged drainage with the use of ADM; seroma formation is common.

Timing and technique of exchange procedure including permanent implant selection — The specific expansion technique used depends on the expander type and fill port location. The integrated port can be located with a magnet; it should be located at the initial surgery, and its position should be confirmed before each expansion. The skin overlying the port is sterilized with a prep solution, and the implant is filled using a small gauge needle (22 to 23 gauge) until the desired volume is reached but before patient discomfort and excessive tightness.

The timing and scheduling of exchanging a tissue expander with the appropriate implant is tailored to each patient. Patients often desire a process that is as quick as possible, but appropriate healing and tissue relaxation are required. The time can range from three months to one year, with no standard timing. The time to fill the expanders usually takes several weeks but varies based on a number of factors. As an example, very rapid times to complete expander fill can be achieved when there is a large amount of available skin envelope, a large percentage of initial intraoperative expander fill volume, and/or prepectoral expander placement. The time has more to do with tissue softening, draping, and patient size acceptance. The use of ADM significantly improves timeliness, as the inferior pole of muscle no longer has to be stretched. The use of skin-sparing mastectomies also permits a more supple skin area that, when combined with ADM, achieves full coverage more quickly and with less distortion. When the size and shape of the expanding breast closely match the opposite breast, a few weeks of delay in scheduling the exchange helps to maintain the shape. Too rapid an exchange will often result in a tighter skin envelope than desired.

The technique of exchange depends on the initial choice of tissue expander. The mastectomy scar is often used for exposure. Using the lateral portion of the scar for exposure may make it easier to achieve good central projection. It may be helpful to perform a partial capsulectomy or capsulotomy release if the capsule around the expander has thickened. Once the pocket is exposed, irrigation with saline and antibiotic solution after expander removal is suggested. Good technique also dictates changing gloves and preparing the site in an attempt to minimize contact with the implant and the patient's skin ("no-touch technique"). (See 'Preventing capsular contracture' below and 'Antibiotic irrigation' below.)

Measuring the fluid volume in the expander also helps with volume and implant choice; the use of an implant sizer can further help with correct implant sizing. The implant is oriented appropriately, drains are placed as necessary but are usually not required, and closure of the incision completes the procedure. Dressings are placed carefully to avoid displacing the implant or producing excessive pressure on the skin.

Following removal of the expander, a permanent implant is usually inserted and usually includes placement of a smooth surface implant; however, in some countries outside the United States, textured surface devices are also considered. Macrotextured devices such as BioCell are no longer available (see 'Types of implants' above); however, other less textured devices are available. In a review of 1077 patients who had reconstruction with a smooth or less textured surface device, complications, and patient-reported outcomes were compared using the BREAST-Q [98]. BREAST-Q scores at 3 and 24 months postoperatively were similar between the smooth and less textured implant. The less textured surface devices were associated with a significant increase in reoperation rate, exchange rate, and cellulitis, whereas smooth implants were associated with more rippling.

Preventing capsular contracture — A "no-touch" technique of implant placement has been advocated as a means to reduce the incidence of capsular contracture, possibly by eliminating any possible contact of the implant with skin or breast bacteria. With this technique, one study of 2863 patients with saline implants followed over 17 years cited a contracture rate of 0.6 percent [99]. A cone-shaped disposable device (Keller funnel) has also been developed to facilitate this technique [100]. However, there are no studies demonstrating a lower capsular contracture rate when this product is used.

A manual pocket dissection technique and the use of drains were associated with capsular contracture in a report of 3002 patients following breast augmentation [101]. Manual dissection increased the risk of capsular contracture sevenfold compared with diathermy dissection, while the use of drains increased the risk more than fourfold. Incision placement and implant pocket location may also play a role in the development of capsular contracture. Implants in the submuscular plane (both saline and silicone) have a decreased contracture rate. In one report of breast augmentation, the incidence of contracture was 0.59 percent in the inframammary incision group and 9.5 percent in the periareolar incision group [102]. This is presumed to be due to greater contamination of the breast pocket, with intraductal bacteria resulting from a periareolar incision. Data from the Danish Registry for Plastic Surgery of the Breast found that 16 percent of 2277 women had capsular contracture at an average follow-up of 1.6 years after implant placement for breast augmentation [103]. Submuscular placement of the implant decreased the risk of capsular contracture, whereas surgical routes other than inframammary and drainage of the implant cavity were associated with an increased risk of capsular contracture.

Textured implants appear to reduce the incidence of capsular contracture, particularly when placed in a subglandular position [104,105]. However, patients may prefer a smooth shell when using saline implants because of less palpability. A systematic review identified seven randomized trials [106]. The risk for capsular contracture was significantly reduced for surface texturing (odds ratio 0.19, 95% CI 0.07-0.52). Contrary to these findings, one small prospective study of 20 women with a subglandular Siltex textured implant (pore size 30 to 70 micrometers) on one side and a smooth implant on the other side did not find a difference in capsular contracture at 7.5 years follow-up [107]. The patients themselves preferred the smooth implants. A similar prospective study by the same investigators was also unable to demonstrate a difference in capsular contracture rates when comparing Biocell textured implants (pore size 300 to 600 micrometers) to smooth implants [108].

A study of 17,656 patients receiving 31,985 textured, shaped implants reported risk factors for capsular contracture [109]. At a median follow-up of 3.4 years, the incidence of capsular contracture ranged from 2.3 to 4.1 percent; malposition, 1.5 to 2.7 percent; and late seroma, 0.1 to 0.2 percent, which included four cases of anaplastic large cell lymphoma. Significant risk factors for capsular contracture were subglandular implant placement, periareolar incision site, older device age in the augmentation cohort, older subject age in the revision-augmentation cohort, and higher body mass index and absence of povidone-iodine pocket irrigation in the reconstruction cohort.

In a review of 211 patients following breast reconstruction using the smooth silk surface device, major complications occurred in 6.5 percent of breasts, and minor complications occurred in 3.4 percent [110]. Rippling occurred more often following prepectoral placement compared with subpectoral (9 versus 1.2 percent, p = 0.001). Capsular contracture was noted in 0.9 percent of breasts and occurred only in the setting of radiation therapy. Implant malposition occurred in 6.5 percent of the breasts.

A systematic review concluded that there are not any reliable and reproducible data to make any firm conclusions regarding the type of implant (saline versus silicone), smooth versus textured, or position (subglandular, submuscular, and subfascial) for preventing capsular contracture [111]. The data loosely support the following conclusions:

●Autologous tissue combined with an implant for breast reconstruction may decrease capsular contracture rates. The use of a latissimus dorsi myocutaneous flap together with an implant for breast reconstruction had a contracture rate of only 3.6 percent at a mean follow-up of almost two years [112].

●Delayed breast reconstruction with tissue expanders and then implants were found to have lower capsular contraction rates compared with immediate reconstruction in a series of 142 patients [113]. This may be due to a lower chance of bacterial contamination at the time of delayed reconstruction compared with immediate reconstruction.

Antibiotic irrigation — Retrospective studies and prospective cohort studies have reported lower rates of surgical site infection and capsular contracture following irrigation of the implant pocket with a combination of antibiotics (eg, cefuroxime or cefazolin and gentamicin) and antiseptics (povidone iodine or bacitracin) [114,115]. Antibiotic pocket irrigation has been used to decrease the risk of bacterial contamination, which may cause capsular contracture [97,114-117]. In the past, irrigation solution consisted of 50 mL of povidone-iodine, 1 g of cefazolin, 80 mg of gentamicin, and 500 mL of normal saline. In 2000, the US Food and Drug Administration (FDA) banned the use of Betadine (povidone-iodine) in the setting of breast implants due to concern over altering the integrity of the implant shell [118-121]. After 2000, the irrigation solution consisted of 50,000 units of bacitracin, 1 g of cefazolin, 80 mg of gentamicin, and 500 mL of normal saline. One of the breast implant manufacturers requested a change to remove warnings regarding the use of Betadine, which was approved in 2017 [122].

Several studies have evaluated the use of antibiotic irrigation, including the use of Betadine.

●In a systematic review comparing three different antibiotic irrigation solutions (ie, chlorhexidine gluconate, betadine, triple antibiotic solution), all three were effective against infection and implant loss when used for pocket irrigation [123].

●In one review of 1244 saline breast implants positioned in a submuscular location for breast augmentation, the incidence of capsular contracture was decreased when dilute Betadine was used as the irrigation solution along with coverage of the nipple-areola complex and incision with Betadine-soaked gauze (compared with data obtained from the FDA and Institute of Medicine) [124]. There was no increase in the incidence of saline implant deflation.

●A study of 436 patients that compared cephalothin (Keflin) implant pocket irrigation fluid in the lumen of the double-lumen implants with no cephalothin reported no significant difference in the development of capsular contraction between the two groups (8.1 versus 5.9 percent) [125].

●However, a study of 335 patients that used a triple antibiotic solution reported a 1.8 percent rate of capsular contracture for patients undergoing primary breast augmentation and a 9.5 percent rate in breast reconstruction patients at a mean follow-up of 14 months [115]. These rates were significantly lower than in other published series. One limitation of this report is that the antibiotic irrigation regimen was changed during the study period.

Oral antibiotics were also examined in a single non-peer-reviewed retrospective study of 249 breast augmentation patients. There was no difference in capsular contracture rates when three days of oral antibiotics (mostly cephalosporins) were administered compared with no antibiotics [126]. Future prevention techniques may focus on the prevention and eradication of implant bacterial biofilms (particularly Staphylococcus epidermidis), which have been found to have a strong link to capsular contracture [127].

COMPLICATIONS AND REOPERATION — 

Complications associated with implant-based breast reconstruction that may or may not lead to reoperation can be classified as complications inherent to surgery and common to all, including seroma, bleeding and hematoma, skin necrosis, and infection, among others, and those specifically related to the reconstruction, such as skin necrosis, implant capsular contracture, implant exposure or malposition, and suboptimal aesthetic appearance. These complications are discussed separately. (See "Complications of reconstructive and aesthetic breast surgery".)

Providers should consider the possibility of breast implant-associated malignancy (anaplastic large cell lymphoma, squamous cell carcinoma, other lymphomas) when treating a patient with late-onset, peri-implant changes such as late-onset seroma or mass. (See 'Implant-associated malignancy' above and "Breast implant-associated anaplastic large cell lymphoma".)

Reoperation — Reoperation on the breast is the most commonly reported complication associated with breast implants for most implant types and indications. Based on manufacturer data, the most frequent indication for reoperation after breast implant placement is capsular contracture, followed by the combination of breast asymmetry and implant malposition.

Reoperation occurs in up to one-third of breast augmentation patients and one-half of breast reconstruction patients [118-121]. In one Canadian study, 88 percent of 3972 women underwent at least one reoperation during an average follow-up of 5.1 years [128]. The reasons for such high reoperation rates are multifactorial and also depend on implant type. Reported rates must be considered in context. A complication may result in a reoperation, but a reoperation is not necessarily related to a complication [129]. As an example, patients' desire for a larger or smaller implant size contributes to reported reoperation rates. In a review of a 15-year experience with 812 patients with breast implants, a significantly increased overall reoperation rate was seen for silicone compared with saline implants, but there was no difference in implant-specific reoperation rates [130]. The investigators concluded that the use of overall reoperation rates as an indication of complications of breast implants can lead to both an overestimation of implant-related complications and to inaccurate conclusions.

The use of acellular dermal matrix (ADM) with implant-based reconstruction is considered by some to be a source of complication and reoperation; however, in most studies, complication rates are not significantly increased [131-133]. In a review of 19 studies, complications were slightly increased in the ADM cohort compared with submuscular implants placed without ADM (15.4 versus 14 percent) [134]. Seroma and infection rates were also slightly increased (4.8 versus 3.5 percent and 5.3 versus 4.7 percent). In a later review from the Mastectomy Reconstruction Outcomes Consortium (MROC) study, there were no significant increases in complication rates, time to exchange, or patient-reported outcomes using ADM [135]. In a review comparing different mesh materials used in the setting of pre- or subpectoral two-stage prosthetic breast reconstruction, poly-4-hydroxybutyrate increased the rate of capsular contracture development [29]. Prepectoral placement with no mesh and dual-plane placement with acellular dermal matrix showed similar timelines of capsular contracture development. The lowest incidences of capsular contracture occurred in the prepectoral placement and no mesh (49 of 161, 30.4 percent) and total submuscular subgroups (3 of 14, 21.4 percent).

Implementing measures to decrease capsular contracture and prevent implant malposition or asymmetry (the two common causes for reoperation) and specific patient evaluation protocols may reduce the likelihood of reoperation [136]. In one series of 50 consecutive silicone gel implant breast augmentation patients, the reoperation rate was 0 percent, with 47 patients following up at three years [137]. This was attributed to specific processes in patient education and informed consent, patient and surgeon decision-making, preoperative assessment and operative planning, implant selection based on individual patient tissue characteristics, surgical techniques, and postoperative care techniques.

Three methods of systematic and comprehensive assessment of potential breast augmentation of the patient's chest tissue characteristics have been proposed to decrease certain complications that result in corrective reoperations.

●The TEPID system addresses the tissue characteristics (T) of the envelope (E), the parenchyma (P), the implant (I), and the dynamics (D) of implant and filler distribution that affect soft tissues [138].

●The High Five decision support process assesses the soft tissue coverage, implant volume, implant dimensions, inframammary fold location, and incision location [139].

●The ICE Principle is a formula for inframammary fold incision planning for determining implant selection and placement and relies on implant dimensions (I) - capacity of the breast (C) = excess tissue required (E) [140].

IMAGING FOLLOWING IMPLANT PLACEMENT — 

The US Food and Drug Administration (FDA) initially recommended that all women with silicone implants undergo regular magnetic resonance (MR) imaging throughout their life to assess for leakage (silent rupture), starting three years after the first implant surgery and every two years thereafter [33]. In 2019, they removed their recommendation for breast implant imaging and surveillance at three, five, and seven years following implantation and have recommended that breast implant imaging begin at five to six years following implantation and every two to three years thereafter using either MR imaging or high-resolution ultrasound for asymptomatic screening [141]. (See "Complications of reconstructive and aesthetic breast surgery", section on 'Rupture of silicone gel implants'.)

There is little evidence to support routine or yearly screening with MR imaging because it is expensive and may lead to anxiety and false positive results, resulting in unnecessary surgery [142,143].

SOCIETY GUIDELINE LINKS — 

Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Breast surgery".)

SUMMARY AND RECOMMENDATIONS

●Breast implants – Breast implants can help restore the breast to normal appearance following mastectomy. Implants may also be used for the reconstruction of congenital or traumatic defects, for the management of significant breast asymmetries, or to improve the aesthetic appearance of an otherwise normal breast. (See 'Introduction' above.)

●Implant composition – Breast implants are composed of an outer silicone shell that is either filled with silicone gel at the time of manufacture or filled with saline either by the surgeon at the time of implant placement or by the manufacturer. Breast implants are available in an array of widths, heights, and projections and may have a smooth or textured surface. (See 'Breast prostheses and other devices' above.)

●Breast implant concerns – Individuals who are contemplating implant-based reconstruction or augmentation understandably have concerns related to the implants, particularly related to issues that have been widely publicized, such as breast implant illness and breast cancer-associated anaplastic large cell lymphoma. Other concerns center around the ability to breastfeed and breast cancer detection. Because of these concerns, in the United States, a mandate from the US Food and Drug Administration (FDA) requires surgeons to review a patient decision checklist with all prospective patients considering breast implants. The patient must be given the opportunity to initial and sign the patient decision checklist, and it must be signed by the physician implanting the device. (See 'Concerns over breast implants' above and 'Informed consent' above.)

•Breast implant illness – Although the causation between breast implants and systemic illness has not been proven, the association persists and is a source of ongoing concern. Patients with suggestive symptoms should be provided reassurance. If the patient wants the implants removed, then explantation should be considered. (See 'Breast implants and systemic illness' above.)

•Breast implant-associated anaplastic large cell lymphoma – Women with textured surface breast implants have a very small but increased risk of anaplastic large cell lymphoma. Risk factors other than the use of certain textured implants have yet to be identified. (See 'Concerns over breast implants' above and "Breast implant-associated anaplastic large cell lymphoma".)

●Implant-based breast reconstruction – Although there are many benefits of autogenous tissue breast reconstruction, implant-based reconstruction will always have a role in breast reconstruction. Compared with purely autologous breast reconstruction, the advantages of implant-based reconstruction are surgical simplicity, the use of cosmetically similar adjacent tissue for coverage of the implant, the lack of donor site morbidity, reduced operative time, and a more rapid postoperative recovery. However, the possible need for radiation treatments needs to be considered; many radiation oncologists will not accept the presence of an implant during radiation treatments (or require the expander to be deflated if it is an expander and not a permanent implant), and implant-based reconstruction following radiation therapy is prone to complications. (See 'Procedure selection and staging' above and "Complications of reconstructive and aesthetic breast surgery", section on 'Radiation therapy' and "Overview of breast reconstruction", section on 'Integrating radiation therapy and breast reconstruction'.)

●Timing and staging of implants – Implant-based breast reconstruction or augmentation can be accomplished in a single stage (direct-to-implant reconstruction [DTI]) or in multiple stages, the first stage of which involves the placement of the tissue expander. The majority of breast augmentations are performed in a single stage. A tissue expander is a silicone shell that is incrementally filled with saline through a port that is either integrated or remotely located. Once the appropriate breast shape has been reached, the expander is removed and replaced with an implant. Whenever there is a skin deficiency or questionable viability of the skin, two-stage reconstruction using a tissue expander or delayed reconstruction should be considered. DTI reconstruction is typically reserved for women who have ample skin following the mastectomy; women with small, nonptotic breasts can generally be reconstructed in a single stage. (See 'Tissue expanders' above and 'Procedure staging' above.)

●Implant positioning – One common technique used for expander/implant placement consists of positioning the device in a pocket deep to the pectoralis major muscle and overlying breast skin (ie, complete muscle coverage). A more natural result may be achieved using a dual plane technique, with superior and middle muscle coverage and the use of an acellular dermal matrix (ADM) for coverage inferiorly to allow a more relaxed breast shape. Measures to prevent capsular contracture may include using diathermy for pocket dissection rather than manual dissection, using a "no-touch" technique of implant placement, and pocket irrigation with an antibiotic solution prior to implant placement; however, there are no reliable and reproducible data to support any of these observations. (See 'Surgical techniques' above and 'Acellular dermal matrix and other meshes' above.)

●Complications – Complications associated with implant-based breast reconstruction that may or may not lead to reoperation can be classified as complications inherent to surgery in general (eg, seroma, bleeding and hematoma, skin necrosis, and infection) and those specifically related to the implant-based breast reconstruction (eg, skin necrosis, implant capsular contracture, implant exposure or malposition, suboptimal aesthetic appearance). (See 'Complications and reoperation' above and "Complications of reconstructive and aesthetic breast surgery".)