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Outcomes Utilizing Inspira Implants in Primary Aesthetic and Reconstructive Surgery

Warren Peled, Anne MD; Disa, Joseph J. MD

Plastic and Reconstructive Surgery: July 2019 - Volume 144 - Issue 1S - p 60S-65S
doi: 10.1097/PRS.0000000000005951
Original Articles
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Summary: The evolution of silicone implants has included advances in both gel and shell technology to improve the clinical outcomes of the implants. The newest generation of implants includes implants with thick, strong shells and highly cohesive gel fill. These advancements allow for better maintenance of implant form and shape over time and improved implant safety. The Natrelle Inspira product line offers 3 different levels of gel cohesivity in a range of profiles to provide a wide variety of options for use in both breast augmentation and postmastectomy breast reconstruction. This article will review the use of Inspira implants in primary aesthetic and reconstructive breast surgery.

San Francisco, Calif.; and New York, N.Y.

From Sutter Health California Pacific Medical Center and Memorial Sloan Kettering Cancer Center.

Received for publication January 7, 2019; accepted April 17, 2019.

Disclosure:Dr. Peled is a consultant for Allergan, Inc. Dr. Disa has no disclosures.

Anne Warren Peled, MD, 2100 Webster Street, Suite 424, San Francisco, CA 94115, drpeled@apeledmd.com, Instagram: @drannepeled, Twitter: @annepeledmd

Recent innovations in implant technology have included improvements in both gel cohesivity and implant fill ratio. Building from some of the advantages seen with anatomic implants, particularly form stability, Allergan developed the Inspira line of round silicone gel implants to address limitations seen in earlier generations of round implants, including rippling and malposition related to the lack of form stability and lower gel–fill ratios. In the development of the line, they created an extensive matrix to maximize patient options, with 5 profiles (low to extra-full) in 3 different levels of gel cohesivity—Responsive (TruForm 1), SoftTouch (TruForm 2), and Cohesive (TruForm 3). With this range of cohesivity, Inspira implants offer the broadest range of cohesivity in the implant market, with the gel within Responsive implants being the least stiff, Cohesive gel being the most, and SoftTouch being in the middle of the range when compared with Sientra and Mentor cohesive gel implants.1 This range offers benefits in both the aesthetic and the reconstructive settings.

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PRIMARY BREAST AUGMENTATION

Patient Evaluation

Physical examination and measurements are key components in optimizing implant selection and outcomes.2 Examination includes assessment of breast parenchyma and the skin envelope, and any prior breast incisions. Qualitative assessment of the parenchymal tightness and skin stretch should be documented to help guide later decisions regarding implant style. Measurements should include the degree of ptosis, sternal notch-to-nipple distance, breast base width, and the nipple-to-inframammary fold distance.

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Implant Selection

In the augmentation setting, women have 3 primary choices to make regarding implant selection: size, implant style/level of cohesivity, and profile.

Biodimensional tissue-based planning is essential for determining appropriate implant size ranges.3,4 Breast base width is the primary determinant of implant size and narrows the potential choices for size, which can then be further narrowed based on patient goals regarding projection and their breast tissue type. Once a size range has been determined, there are various ways to help patients understand what their potential outcomes might be with different sizes, including three-dimensional imaging systems or patient-sizing tools.

Implant style/level of cohesivity and profile selection are determined primarily from patient tissue characteristics and patient preference.5 Women with tighter skin envelopes and constricted or tuberous breasts are often better suited for more cohesive implants (Fig. 1), whereas women with looser skin envelopes and parenchyma (who might be undergoing concurrent tissue rearrangement with a mastopexy) can have excellent outcomes with less or moderately cohesive implants (Fig. 2). Showing women a range of outcomes with different implant projections, either with representative patient photos or through 3D imaging, can help optimize understanding patient expectations and goals.

Fig. 1.

Fig. 1.

Fig. 2.

Fig. 2.

In the authors’ augmentation experience, SoftTouch implants seem to offer the ideal balance of increased form stability as compared with Responsive implants or comparable less cohesive implants from other implant companies while still maintaining reasonable softness. These benefits are particularly important in patients with suboptimal soft tissue quality, as these patients benefit from the increased gel cohesivity to help maintain upper pole projection and minimize rippling and malposition, but may also be more likely to feel the firmness associated with a more cohesive implant. However, in patients with a sizeable amount of breast tissue and good soft tissue quality who are just seeking to augment the size and shape of their natural breasts without needing the implant to help shape their soft tissues, they can achieve good results with lower cohesivity gel implants such as Responsive.

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Outcomes

Given the recent introduction of Inspira cohesive implants to the US market (FDA approval was announced in September of 2016), outcomes data on the use of the implants are currently limited. A recent Canadian study6 reported outcomes from 319 women after primary augmentation with either Natrelle Inspira TruForm 1 (“Responsive”; 15 women) or TruForm 2 (“SoftTouch”; 304 women) implants. Although overall follow-up time was fairly short (overall follow-up of 2–4 years), the authors reported low rates of adverse events in the TruForm 2 group (10.7%), which was slightly higher in the textured group (14.1%) than the smooth (9.8%). Overall reoperation rate was 9.9%, primarily related to malposition (37%), capsular contracture (33%), and size/style change (20%).

Given that the follow-up time using Inspira devices in both the augmentation and revision settings in our practices and others is limited, evaluation of more long-term complications such as capsular contracture and malposition cannot be well evaluated. Anecdotally, however, we have seen improved maintenance of upper pole projection in both the augmentation and reconstructive settings, and less rippling, particularly in thinner skin patients. Further studies will eventually help to quantify these suspected benefits and assess the long-term safety.

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PRIMARY BREAST RECONSTRUCTION

Patient Evaluation

Physical examination and measurements for women undergoing mastectomy and implant-based reconstruction are similar to those for augmentation. Attention to any prior breast surgery or other treatment such as radiation therapy or axillary node surgery is important for optimizing outcomes and appropriate technique selection.7,8 Communication with the oncologic surgeon regarding the likelihood of adjuvant radiation therapy and any planned skin resection at the time of mastectomy and extent of axillary surgery is also essential for optimal planning.

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Implant Selection

As final reconstructive outcomes are very dependent on patient body habitus and mastectomy skin flap thickness and quality, anticipated postreconstructive outcomes can be more challenging to predict preoperatively. This challenge can often make it more difficult in primary reconstruction than it is in primary augmentation to have an informed discussion preoperatively with patients about what the optimal implant size and profile might be. Perfoming 2-stage expander–implant reconstruction can potentially improve implant selection by better understanding tissue characteristics and patient expectations,9 including giving women the opportunity to see what specific implant sizes would look like on them during the expansion process before making a final decision about implant size. However, with using similar biodimensional planning to that used in breast augmentation and a clear discussion with patients about their postoperative goals, direct-to-implant reconstruction can be done with low rates of complications10 and unplanned secondary procedures for implant size changes.11,12

Without any breast tissue in front of the implant, implant characteristics and properties are more visible and pronounced with breast reconstruction than breast augmentation, particularly with prepectoral reconstruction. With more visibility, implant selection becomes even more important. Lower cohesivity implants (such as Natrelle Inspira Responsive) will likely not provide sufficient maintenance of upper pole projection in the reconstructive setting, and overall rippling will be more apparent.13–15 With higher cohesivity implants (such as Natrelle Inspira SoftTouch or Cohesive), upper pole projection is maintained upright to a much greater extent, providing much-needed upper pole fullness after mastectomy (Figs. 3 and 4). More form-stable implants can feel firmer to patients, however, so preoperative discussion with women about the different options and potentially letting them feel samples of the different types of cohesive implants can be helpful for appropriate expectation setting.

Fig. 3.

Fig. 3.

Fig. 4.

Fig. 4.

In our reconstructive experience, particularly with thinner patients and implants placed in the prepectoral plane, we have found that Responsive implants are often unable to provide sufficient maintenance of upper pole projection and can have high rates of visible rippling and wrinkling. As a result, we primarily use SoftTouch and Cohesive implants in the reconstructive setting, which address both of these issues and provide durable results (with the limited follow-up we have thus far).

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Outcomes

As with outcomes data following primary augmentation with Inspira cohesive implants, data on use of the implants in the reconstructive setting are limited. However, some of the most recent articles on prepectoral reconstruction include outcomes with these implants as part of larger studies (albeit with short follow-up). Recent studies have shown good outcomes demonstrated by low rates of complications, safety in both the previously irradiated breast and following postmastectomy radiation therapy, and clinical applicability in challenging patients.16,17

Particularly in the reconstructive setting, we have found the extensive matrix of different implant volumes, projections, and cohesivities within the Inspira line to offer significant value when compared with other implant types. Although there is a trade-off of increased firmness with increased cohesivity (Fig. 5), the ability with more cohesive implants to provide improved upper pole projection with decreased possibility of rippling due to the higher fill ratio has a major benefit in the postmastectomy setting. Additionally, having multiple profiles (typically moderate, full, or extra-full for reconstruction) available in the higher cohesivity gel allows for greater flexibility and options for patients to help them achieve their desired outcome, particularly in the setting of unilateral mastectomy when trying to achieve symmetry with the nonmastectomy breast.

Fig. 5.

Fig. 5.

One potential downside of highly cohesive implants, particularly in higher projection, larger volume implants, is the possibility of implant malposition/flipping in the anterior–posterior direction. Although it has not been well-studied yet, the cause is thought to be a mechanical one related to the “top heavy” nature of higher projection, more cohesive implants, which can rotate from back-to-front in the implant pocket, causing a visible deformity of the breasts and a flattened appearance to the implant. Anecdotally, it has been seen more often in the reconstructive setting, but this is likely related to increased ease of identification following mastectomy as compared with augmentation, where native breast tissue is still present in front of the implant and, thus, it may not be identified as frequently. Careful pocket control and consideration for intermediate cohesivity for larger volume, high-profile implants have been suggested as strategies to minimize the risk of this type of implant malposition. Fortunately, when it does occur, patients can typically “flip” the implant back on their own with simple maneuvers.

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CONCLUSIONS

Women undergoing primary breast augmentation or implant-based reconstruction can achieve excellent outcomes with Inspira implants with a wide range of options available for patients. Appropriate patient assessment and preoperative discussion of goals and expectations is essential to optimize outcomes.

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