Breast Augmentation - Plastic Surgery Practice https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/ Plastic Surgery Practice is the brand that 12,000 plastic surgeons rely on for the latest information on the clinical innovations, practice-management trends, emerging products and technologies, and news stories that drive their field. With well-thought-out articles by leading practitioners, PSP gets to the core of the most complex issues in plastic surgery, including controversial new treatments, the use of highly technical equipment, and physician-patient interactions. Fri, 11 Apr 2025 17:26:47 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 New Breast Aesthetics Consensus Centers on Natural Outcomes https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/new-breast-aesthetics-consensus-centers-natural-outcomes/ https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/new-breast-aesthetics-consensus-centers-natural-outcomes/#respond Fri, 11 Apr 2025 17:26:40 +0000 https://plasticsurgerypractice.com/?p=121753 Global plastic surgeons have released a new consensus on natural breast aesthetics, aiming to reduce revision surgeries and counter trend-driven procedures.

In response to growing concerns over “fake-looking” results and rising revision surgeries in aesthetic breast procedures, a group of plastic surgeons from around the world has launched a new international consensus on natural beauty in breast aesthetics, presented at Palazzo Turati in Milan.

With breast augmentation now an almost $3 billion global industry growing at 7.5% annually, experts warn that the trend toward hyper-curated aesthetics—amplified by social media—risks prioritizing trends over health and harmony. The new consensus provides a science-based framework for natural outcomes tailored to each woman’s anatomy and long-term well-being.

“The demand for aesthetic surgery is rising, but too often shaped by unrealistic expectations,” says professor Roy De Vita, plastic surgeon at the Istituto dei Tumori Regina Elena in Rome, in a release. “Many women walk into their first consultation asking for a specific brand or implant shape they saw on Instagram. But implants are medical devices just like orthopedic or cardiac implants—not accessories. You wouldn’t choose a heart valve that way.”

The consensus addresses six of the most commonly misunderstood areas of breast surgery, from implant choice and patient expectations to safety protocols and facility selection. The recommendations reflect a growing global shift toward individualized, anatomy-based approaches that deliver subtle, long-lasting beauty.

The ‘Natural Breast Beauty’ Approach

“Large doesn’t equal beautiful,” says Patrick Mallucci, MD, British plastic surgeon and co-author of an international ideal breast shape study, in a release. “Beauty is about proportions—typically a 45:55 ratio between the upper and lower pole of the breast. This creates a natural, slightly concave upper area and a full, rounded lower area. It’s geometry, not guesswork.”

The Natural Breast Beauty methodology blends clinical precision with a growing cultural demand for results that feel authentic—not artificial. “Patients increasingly want to look and feel good without being judged by extremes,” says Mallucci in a release. 

Educating Women, Combating Misinformation

The global breast implant market reached $2.78 billion in 2024, with $890 million in the US alone and $1.89 billion internationally. That number is expected to double by 2034, fueled by both reconstructive and aesthetic procedures.

“This is not just a business—it’s a responsibility,” says professor Karsten Hemmrich, CEO of POLYTECH Health & Aesthetics and former plastic surgeon, in a release. “We’re seeing two major global shifts: women seeking natural, harmonious outcomes and a growing demand for safety and scientific rigor in device manufacturing.”

The consensus also serves as a call to action against misleading content online. “Social media is full of unrealistic before-and-after photos, DIY comparisons, and influencer promotions,” says Mariangela Dal Prá, managing director Italy and head of sales Central Europe at POLYTECH Health & Aesthetics, in a release. “We want women to be empowered—not manipulated. Sometimes the best decision is to wait, or even to avoid surgery altogether.”

ID 139677225 © Chernetskaya | Dreamstime.com

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Five-Year Data Show Low Complication Rates for Motiva Breast Implants https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/five-year-data-show-low-complication-rates-motiva-breast-implants/ https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/five-year-data-show-low-complication-rates-motiva-breast-implants/#respond Wed, 26 Mar 2025 14:23:21 +0000 https://plasticsurgerypractice.com/?p=121680 Midpoint data from a 10-year clinical study show low rates of reoperation, rupture, and capsular contracture in primary augmentation patients.

Establishment Labs Holdings Inc, a medical technology company specializing in breast aesthetics and reconstruction solutions, noted a presentation of an update on the Motiva US IDE Study regarding five-year patient follow-up data for primary augmentation subjects. 

The medical director of the study, Caroline Glicksman, MD, who is also an investigator in the study, will present the results at The Aesthetic MEET 2025, the annual meeting of The Aesthetic Society, in Austin, Texas.

Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the five-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at four years was 88.5%. The five-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows:

Primary Augmentation5-year (N=451), 95% CI
Capsular contracture (Baker Grade III/IV)0.5%
Rupture, suspected or confirmed; MRI cohort10.6%
Breast pain1.2%
Infection0.9%
Implant removal, with or without replacement3.1%
Any reoperation28.8%
Any complication312.0%

“At the mid-point of the 10-year core study, Motiva implants continue to show low rates of complication,” says Glicksman in a release. “The consistency in these clinical results is particularly notable, as we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture since we began reporting at two years. Overall, patient follow-up remains very high, and the rates of complication remain very low.”

Establishment Labs received approval from the US Food and Drug Administration for the use of Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants in primary and revision breast augmentation on Sept 26, 2024.

Our momentum in the US continues to exceed expectations,” says Peter Caldini, Establishment Labs’ interim CEO, in a release. “This is driven by differentiated clinical data, along with the complete lack of innovation in this market for years. Our core thesis is proving true: better technology can improve patient outcomes, take market share, and expand the market. We now have over 800 accounts on board with more than 550 placing orders.”

1 MRI cohort N=176

2 Any surgery on the breast or chest area, device or non-device related, including size change

3 Any device or non-device related event, including reoperation

File photo / Motiva implant

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BD Begins Clinical Trial for GalaFLEX LITE Scaffold in Breast Revision Surgery https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/bd-begins-clinical-trial-for-galaflex-lite-scaffold-in-breast-revision-surgery/ https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/bd-begins-clinical-trial-for-galaflex-lite-scaffold-in-breast-revision-surgery/#respond Thu, 20 Mar 2025 19:12:43 +0000 https://plasticsurgerypractice.com/?p=121640 BD begins a clinical trial to evaluate GalaFLEX LITE Scaffold for reducing capsular contracture in breast revision surgery, aiming for FDA approval.

BD (Becton, Dickinson and Company), a global medical technology company, announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD’s efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery.

Understanding Capsular Contracture

Capsular contracture, a condition where the scar tissue naturally forming around the implant becomes unusually hard, causes pain and anatomical displacement and is its most frequent complication during implant-based breast surgery, with overall incidence ranging from 10% to 20%. At advanced stages, CC necessitates treatment through surgical intervention, and when performed using conventional techniques, the risk of recurrence may be as high as 54%, according to a press release from BD. 

About the STANCE Clinical Trial

This multi-center Study of GalaFLEX LITE Poly-4-Hydroxybutyrate (P4HB) Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation (STANCE) is aims to evaluate whether GalaFLEX LITE Scaffold, when used in breast revision surgery, decreases the likelihood of CC and or malposition. 

BD’s Commitment to Surgical Innovation

“This milestone marks a significant advancement in our efforts to achieve FDA Premarket Approval for our first breast indication for GalaFLEX LITE Scaffold and reinforces the company’s commitment to improving patient outcomes through innovative technologies that reduce surgical complications,” said Rian Seger, worldwide president of the BD Surgery business. “Our team has worked closely with the FDA to help address a critical medical complication arising from implant-based breast surgery, and the first patient treated brings us closer to delivering a much-needed solution.”

How GalaFLEX LITE Scaffold Works

According to the company, GalaFLEX LITE Scaffold is engineered to conform to the desired anatomical structure and provide immediate strength and stability throughout the wound healing period. It is made from P4HB, a fully absorbable, biologically-derived polymer with more than 10 years of clinical use supporting hernia repair and other plastic and reconstructive procedures where soft tissue weakness or deficiency exists.

Surgeons Highlight the Importance of the Study

“Participating in this trial underscores our commitment to innovation and providing the best evidence-based care for patients suffering from capsular contracture, offering them hope and solutions for the future,” said Dr Shawna Kleban, the board-certified plastic surgeon who performed the inaugural procedure. “This trial allows participants to help identify a solution for themselves and for future patients.”

Dr Caroline Glicksman, the study’s National Principal Investigator from Sea Girt, NJ, added, “As an early adopter of the P4HB technology, we are excited to see the potential benefits of GalaFLEX LITE Scaffold in improving patient outcomes in breast revision surgeries. This study is crucial in providing the data FDA requires for a specific breast indication that will advance our ability to deliver better solutions for breast surgery patients.”

GalaFLEX LITE Clinical Trial Sites and Enrollment

The following five sites are currently enrolling patients:

  • HKB Cosmetic Surgery (various locations, North Carolina) – Principal Investigator: Dr Bill Kortesis; Sub-Investigators: Dr Gaurav Bharti, Dr Shawna Kleban, Dr Brett Baker
  • Billington Plastic Surgery (St Petersburg, Fla) – Principal Investigator: Dr Alicia Billington
  • The Practice Plastic Surgery (Beverly Hills, Calif) – Principal Investigator: Dr Kelly Killeen; Sub-Investigator: Dr Lisa Cassileth
  • Plastic Surgery Institute of New York (New York) – Principal Investigator: Dr Matthew DelMauro; Sub-Investigator: Dr Adam Shaffner
  • Newport Plastic and Reconstructive Surgery Associates (Newport Beach, Calif) – Principal Investigator: Dr Hisham Seify
  • Essential Medical Research (Tulsa, Okla) – Principal Investigator: Dr John Tedesco

GalaFLEX LITE Study Goals and Randomization

The trial is expected to enroll at least 250 patients across 40 investigative sites and aims to demonstrate the device’s safety and efficacy in breast implant revision surgery to treat capsular contracture. 

Details of the STANCE Study

STANCE (NCT05945329) Study is an ongoing prospective, randomized, controlled, multi-center study to assess the safety and efficacy of GalaFLEX LITE scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Patients will be randomized 2:1 to receive either GalaFLEX LITE Scaffold or standard care (no ADM or matrix placement). 

Photo: BD

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Establishment Labs Launches Preservé for Aesthetic Breast Augmentation in Brazil https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/enhancements/establishment-labs-launches-preserve-for-aesthetic-breast-augmentation-in-brazil/ Wed, 19 Feb 2025 00:30:00 +0000 https://plasticsurgerypractice.com/?p=121439 Summary: Establishment Labs has launched Preservé in Brazil, expanding its minimally invasive breast aesthetics platform with a focus on breast tissue preservation for more natural and stable results. Utilizing proprietary surgical tools and Ergonomix2 implants, Preservé aims to improve safety, recovery, and long-term outcomes, with a global rollout planned.

Key Takeaways:

  • Preservé builds on the technology of Mia Femtech to offer a less invasive alternative to traditional breast augmentation, enhancing safety, recovery, and aesthetic outcomes.
  • The new breast tissue preservation platform could expand the pool of women considering augmentation while driving growth and profitability for Establishment Labs.
  • After debuting in Brazil, Preservé will be introduced in other markets worldwide, though it is not yet approved for commercial use in the U.S.

Establishment Labs Holdings Inc, a global medical technology company focused on women’s health and wellness in breast aesthetics and reconstruction, announced it has launched Preservé in Brazil, the first country in its global rollout. Preservé is the second product in the company’s minimally invasive platform, building upon the technologies and techniques developed with Mia Femtech, Establishment Labs’ minimally invasive experience.

Addressing Patient Concerns with Minimally Invasive Solutions

“These are not small innovations, this is an entirely new era for aesthetic breast surgery,” said Juan José Chacón-Quirós, founder and CEO of Establishment Labs. “Whereas Mia made minimally invasive breast aesthetics possible for women looking for a one to two cup enhancement, Preservé allows less invasive breast surgery for the day-to-day breast augmentation patient.”

“Historically, many women have not been convinced by traditional methods and legacy techniques,” Chacón-Quirós continued. “With Mia and Preservé, we have solutions that address these concerns. The technology platform of breast tissue preservation allows plastic surgeons to create natural results with less disruption of the patient’s breast tissue. By improving safety profiles, recovery times, and achieving the breast aesthetic patients are looking for, breast augmentation may now be possible for women that otherwise never would have considered it—as well as making the decision easier for many who were already considering. After Brazil, Preservé will rollout globally over the next few years, and this should contribute to top line growth and profitability.”

Regulatory Status and U.S. Availability

The medical devices used in Preservé are not yet approved for commercial distribution in the United States.

Breast Augmentation with Tissue Preservation

According to the company, Preservé was designed to preserve breast tissue during aesthetic breast surgery, maintaining the structural anatomy and function of the breast for more stable and natural outcomes when compared to traditional breast augmentation. Preservé reportedly leverages Establishment Labs’ proprietary minimally invasive surgical tools coupled with the Ergonomix2 implants, which feature the patented SmoothSilk surface, designed for enhanced biocompatibility and softness; in addition, their shape adapts as the body changes position. Preservé is intended for primary augmentations up to four cups, hybrid augmentations, and mastopexy augmentations.

“Breast tissue preservation is a new paradigm in breast aesthetics. With less invasive breast procedures made possible by technology pioneered by Establishment Labs, we can address many of the complications that lead to reoperations,” said Dr Kamakshi Zeidler, San Francisco plastic surgeon and head of the Femtech board of Establishment Labs. “Preservé is an incredible new choice for women considering breast augmentation because it speaks to many of their aspirations, including smaller scars, quicker recovery, maintaining breast sensation, and avoiding unnecessary reoperations.”

Launch Event and Global Expansion Plans

The commercial launch of Preservé took place last weekend at the Brazilian Breast Meeting in Rio de Janeiro with over 300 surgeons in attendance and included live surgery and academic sessions. This year additional launches of Preservé are planned around the world.

Photo: ID 136326144 © Chernetskaya | Dreamstime.com

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First U.S. Women Receive Breast Augmentation with FDA-Approved Motiva Implants https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/first-u-s-women-receive-breast-augmentation-with-fda-approved-motiva-implants/ Fri, 04 Oct 2024 18:06:53 +0000 https://plasticsurgerypractice.com/?p=121074 Summary: Establishment Labs Holdings Inc, a global medical technology company specializing in women’s health, announces the first U.S. breast augmentations using Motiva Implants.

Key Takeaways

  1. Establishment Labs performed the first U.S. breast augmentations using FDA-approved Motiva Implants.
  2. The FDA approval has increased demand, leading the company to expand its sales team.
  3. Motiva Implants are designed to improve biocompatibility, reduce inflammation, and mimic natural movement.

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Establishment Labs Holdings Inc, a global medical technology company specializing in women’s health, announces the first U.S. breast augmentations using Motiva Implants.

“With the FDA approval last week, we are experiencing high demand for Motiva Implants—both from surgeons and patients,” says Juan José Chacón-Quirós, founder and CEO of Establishment Labs. “The FDA approval came as we were attending the annual conference of the American Society of Plastic Surgeons. The response was overwhelming, and our team has already talked to more than 400 plastic surgeons post announcement. Since approval, we have already doubled our team to 25 sales reps across the United States, and our story of real innovation, backed by science and data, is resonating strongly. Everything we are seeing suggests that we can be the implant of choice in the United States.”

Milestone for Motiva SmoothSilk Breast Implants

M. Bradley Calobrace, MD, Kentucky-based board-certified plastic surgeon, and Caroline A. Glicksman, MD, New Jersey-based board-certified plastic surgeon, performed the first surgeries following the U.S. FDA approval of Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants in primary and revision breast augmentation.

“I have many patients that have been waiting a long time for Motiva approval, in some cases, for years,” says Calobrace. “I was delighted to perform one of the first Motiva breast augmentations in the United States. The innovation in these devices not only enhances aesthetics outcomes, but also significantly lowers the rates of the complications we see with other devices. Motiva implants are a game-changer.”

Enhanced Biocompatibility and Reduced Inflammation

Motiva Implants feature a SmoothSilk surface for enhanced biocompatibility and reduced inflammation. The Ergonomix implants mimic natural breast movement, changing shape based on body position, while the SmoothSilk Round implants offer fullness and softness in all positions.

“The plastic surgery community has waited over a decade for a truly new option,” adds Glicksman, medical director of the Motiva U.S. IDE Study. “Now, we can confidently offer implants with low complication rates and high patient satisfaction.”

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CollPlant, Stratasys Explore 3D-Printed Breast Implants https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/collplant-stratasys-explore-3d-printed-breast-implants/ Fri, 23 Aug 2024 16:53:37 +0000 https://plasticsurgerypractice.com/?p=120935 Summary: CollPlant Biotechnologies and Stratasys Ltd. have initiated a pre-clinical study to develop 3D-printed regenerative breast implants that promote natural tissue growth and biodegrade over time.

Key Takeaways

  1. Innovative Collaboration: CollPlant Biotechnologies and Stratasys Ltd. are collaborating to develop 3D-printed regenerative breast implants using CollPlant’s bioinks and Stratasys’ Origin printer. This partnership aims to scale up bioprinting solutions for the $3 billion breast implant market.
  2. Regenerative Potential: The 200cc implants, currently under pre-clinical study, are designed to promote natural breast tissue growth and biodegrade completely over time, offering a potential alternative to traditional silicone implants with the added benefit of not triggering an immune response.
  3. Promising Pre-Clinical Results: Early pre-clinical data shows that the implants support tissue regeneration and initial biodegradation without adverse reactions, indicating the implants’ safety and effectiveness. The first study results are expected in the first half of 2025.

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CollPlant Biotechnologies and Stratasys Ltd. launched a pre-clinical study using 200cc regenerative implants, 3D-printed with CollPlant’s bioinks on a Stratasys Origin printer. The collaboration is focused on developing and scaling up bioprinting solutions for breast implants. The study will assess the implants’ ability to promote natural breast tissue growth and their potential for complete biodegradation over time.

Regenerative Breast Tissue Implants

CollPlant’s breast implants are designed to regenerate natural breast tissue without triggering an immune response and could serve as an alternative for reconstructive and aesthetic procedures in the $3 billion breast implant market.

“This pre-clinical study marks a significant step forward in our effort to provide patients with care using regenerative medicine instead of traditional implants,” says Stratasys CEO Yoav Zeif, PhD. “CollPlant’s work is truly inspiring, and our collaboration exemplifies how Stratasys partners with customers to push the timeline and the boundaries of innovation. Together, we are driven by a shared mission to challenge the status quo and find new ways to improve lives and advance healthcare.”

High-Resolution Regenerative Implants

CollPlant CEO Yehiel Tal also spoke out about the pre-clinical study, commenting: “We are extremely happy about the progress we’ve made with our breast implants program, and with Stratasys’ successful achievement to develop a printer that enables us to print a commercial-size implant with high resolution and optimal physical properties. The combined pioneering technologies of both companies is expected to streamline the development and production process so that we have the most efficient means to produce our regenerative breast implants.”

“We believe that our rhCollagen-based regenerative implant has the potential to overcome the challenges of existing breast procedures that use silicone implants or autologous fat transfer, thereby significantly improving patient outcomes,” Tal adds.

Since their collaboration began in April 2023, Stratasys has adapted the Origin printer to produce 200cc regenerative implants, which CollPlant has successfully 3D-printed. Initial study results are expected in the first half of 2025.

Earlier this year, CollPlant reported data from ongoing pre-clinical studies showing well-developed connective tissue and blood vessels forming within the implant. Tissue regeneration and initial biodegradation were observed, with the implant’s structure remaining intact. No adverse tissue reactions were detected, indicating the implant’s safety.

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CollPlant Bio-Prints 200cc Regenerative Breast Implants https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/collplant-bio-prints-200cc-regenerative-breast-implants/ Fri, 07 Jun 2024 12:08:36 +0000 https://plasticsurgerypractice.com/?p=120769 Summary: CollPlant Biotechnologies successfully 3D printed 200 cc commercial-size breast implants using rhCollagen bioinks, with positive interim preclinical data showing promising tissue regeneration and no adverse reactions, suggesting a potential alternative for aesthetic and reconstructive procedures.

Key Takeaways

  • Bio-printing technology now enables fabrication of 200cc implant size and above to address future commercial demand.
  • Interim pre-clinical data shows tissue growth including regeneration of maturing connective tissue as well as neovascularization, synchronized with progressive implant degradation.
  • No adverse tissue reaction was observed.
  • Large-animal studies with commercial-size implants are currently underway with results expected in the fourth quarter of 2024 and the first quarter of 2025.

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CollPlant Biotechnologies has successfully 3D printed 200 cc commercial-size breast implants using its proprietary rhCollagen bioinks. Additionally, interim preclinical data from ongoing large-animal studies show positive results for their regenerative breast implants.

Regenerative Breast Implant Advancements

“Through the development of regenerative breast implants, CollPlant is establishing the technological building blocks that are essential for tissue and organ manufacturing,” says Yehiel Tal, CollPlant’s CEO. “During the last year, we have upgraded our bioprinting process and capabilities to fabricate 200CC-size implants, which will be included in future studies. The data we see from the animal studies, such as tissue regeneration, are very encouraging, and we are looking forward to reporting results from additional ongoing animal studies in the fourth quarter of this year and in the first quarter of 2025.”

Additional positive data from CollPlant’s pre-clinical studies show evidence of well-developed connective tissue containing blood vessels (i.e., neovascularization) within the implant. Progressing tissue ingrowth within the implant was also observed, confirming tissue regeneration. An initial biodegradation process was observed, while preserving the original structure of the 3D breast implant. No adverse tissue reaction was observed, confirming the safety profile of this novel implant in development.

3D-Bioprinted Implants May Reduce Complications

The most common breast augmentation or reconstruction procedures today are based on synthetic silicone breast implantations, an artificial substitution for natural regenerated tissue with risks of complications.

In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. CollPlant’s rhCollagen-based, 3D-bioprinted breast implants that are comprised of CollPlant’s proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and therefore may provide an alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.

New Hope for Breast Reconstruction

CollPlant’s regenerative breast implants have the potential to provide a solution for women in need of breast reconstruction and augmentation, the need of which is sizeable, as it is the second most common plastic surgery procedure performed worldwide today.

In December 2023, CollPlant initiated an additional large-animal study to evaluate commercial-size versions of the 3D-bioprinted, regenerative breast implants. This study will be used to obtain data to support subsequent human studies and future product commercialization. CollPlant expects to report topline data from this study, and an additional ongoing study, in the fourth quarter of this year and first quarter of next year.

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GC Aesthetics Unveils MDR-Approved Breast Implant https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/gc-aesthetics-unveils-mdr-approved-breast-implant/ Wed, 24 Apr 2024 00:32:47 +0000 https://plasticsurgerypractice.com/?p=120614 Key Takeaways
  1. The Introduction of Luna XT marks a milestone as the first MDR-approved breast implant, reflecting a shift toward enhanced safety standards in the medical field.
  2. Escalating numbers of breast reconstruction surgeries underscore the demand for MDR-approved products, highlighting the importance of stringent safety standards.
  3. Luna XT is designed to meet diverse patient needs in breast reconstruction surgery.

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Breast implant provider GC Aesthetics (GCA) has introduces Luna XT, the first breast implant approved under the new European Medical Device Regulation (MDR). GCA officials say these regulations prioritize product safety, transparency, and clinical evidence, marking a significant shift in medical standards.

Rising Number of Breast Reconstruction Surgeries

The demand for MDR-approved products, devices, and implants is underscored by the escalating numbers of breast reconstruction surgeries. According to the NHS website, the UK witnessed 2,100 breast reconstruction surgeries in 2022, with a further 460 procedures carried out through independent/private clinics. This marks a notable 36% increase since 2017, highlighting the necessity for products adhering to stringent safety standards outlined in the new MDR.

The Luna XT Anatomical Breast Implant is designed to support women undergoing immediate and delayed breast reconstruction surgery. It features a microtextured surface, cohesive silicone gel, and high-performance shell, reflecting advancements in the field. Luna XT is available in different projections, heights, and volumes to meet various patient needs.

First MDR-Certified Breast Implant

Carlos Reis Pinto, CEO at GC Aesthetics, endorsed Luna XT, stating: “Being the first to launch the first MDR-approved breast implant in the market is a testimonial of GC Aesthetics’ commitment to women’s healthcare and safety. MDR rules have been designed to improve product safety ensuring greater openness, traceability, and clinical safety evidence. Having the first breast implant manufacturing system in the world certified under the new MDR rules demonstrates that our company continues to pursue excellence and customer satisfaction.” 

Fara Naomi Macías, chief marketing officer of GCA, also spoke out about Luna XT: “It is GC Aesthetics’ commitment to offer a strong and comprehensive portfolio of products for women. We are committed to delivering safe options that establish a newer, higher, and more beneficial standard of care for women who seek to recover their breast and nipple shape, look, and feel.”

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The Aesthetic Society, The Aesthetic Foundation Launch ARISE: Breast Implant Registry https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/the-aesthetic-society-the-aesthetic-foundation-launch-arise-breast-implant-registry/ Tue, 19 Mar 2024 20:15:12 +0000 https://plasticsurgerypractice.com/?p=120553 The Aesthetic Society and The Aesthetic Foundation have launched the American Registry for Breast Implant Surveillance (ARISE) through their Aesthetic One app, partnering with a U.S. FDA-recognized platform to transform breast implant registries. ARISE enables implant registration with manufacturers and contributes data to the registry, currently comprising over 45,000 registered implants, making it one of the nation’s most extensive breast implant registries.

“ARISE represents a leap forward in patient safety, outcomes research, and overall quality improvement in breast implant procedures,” says Caroline Glicksman, MD, president of The Aesthetic Foundation. “By leveraging the Aesthetic One app, ARISE collects unbiased, validated data that will be reported to regulatory bodies and utilized to collaborate with other international breast implant registries.”

David Sieber, treasurer of The Aesthetic Foundation, also spoke out about ARISE, adding: “By seamlessly integrating Aesthetic One with the ARISE registry, we are not only enhancing efficiency but also elevating the standard of care for our patients.”

Aesthetic One’s interface streamlines data collection with dropdown menus and a built-in scanner, allowing quick implant registration and data entry by surgeons and staff in under two minutes. Since its 2021 launch, over 700 physicians have adopted Aesthetic One, aiding in the growth of the ARISE registry. Through ARISE, The Aesthetic Society leads initiatives focused on:

  • Patient safety: Monitoring and tracking the safety and performance of breast implants over time for early detection of potential issues or complications.
  • Outcome research: Facilitating comprehensive research on the outcomes of breast implant surgeries, including long-term effects, complications, and patient satisfaction.
  • Quality improvement: Providing data for surgeons, regulatory authorities, and manufacturers to identify trends, assess implant effectiveness, and improve the quality and safety of procedures.
  • Regulatory compliance: Meeting regulatory standards by establishing registries to ensure approved implants meet safety and efficacy criteria.
  • Surveillance of trends: Monitoring trends in breast implant utilization, aiding healthcare professionals, researchers, and policymakers.
  • Evidence-based decision-making: Using registry data to make evidence-based decisions regarding implant selection, surgical techniques, and postoperative care for improved patient outcomes.

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Neural Network Enables Objective Assessment of Breast Symmetry https://plasticsurgerypractice.com/client-objectives/aesthetics/breast-augmentation/neural-network-enables-objective-assessment-of-breast-symmetry/ Thu, 25 Jan 2024 00:39:42 +0000 https://plasticsurgerypractice.com/?p=120432 A newly developed neural network is highly accurate in identifying key landmarks important in breast surgery—opening the potential for objective assessment of breast symmetry, suggests a study in the February issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons(ASPS).

“Neural networks and machine learning have the potential to improve evaluation of breast symmetry in reconstructive and cosmetic breast surgery, enabling rapid, automated detection of features used by plastic surgeons,” comments lead author Nitzan Kenig, MD, of Albacete University Hospital in Spain.

Creating Neural Networks for Breast Evaluation

Breast symmetry is a key concern in breast surgery and is generally assessed by simple subjective evaluations by both patients and surgeons. Computer programs can provide more objective assessments, but with limitations including the need to manually enter data and lengthy calculation times.

Neural networks—an artificial intelligence technique that seeks to emulate the way the human brain processes data—are being explored for their potential to improve care in several areas of medical practice. Kenig and his colleagues developed an “ad hoc convolutional neural network” to detect key breast features used in assessing breast symmetry.

Using an open-source algorithm called YOLOV3 (“You Only Look Once,” version 3), the researchers trained their neural network to identify three anatomic features used in assessing the female beast: the breast boundaries, the nipple-areola complex (nipple and surrounding tissue) and the suprasternal notch (the depression at the base of the neck, at the top of the breastbone).

The neural network was trained using 200 frontal photographs of patients who underwent breast surgery. Its performance in identifying key breast features was then tested using an additional set of 47 photographs of patients who underwent breast reconstruction after breast cancer surgery.

Swift, Automated, Objective Breast Symmetry Evaluation

After training, the neural network was highly accurate in localizing the three features, with a total detection rate of 97.7%. For the right and left breast boundaries and nipple-areola complex, accuracy was 100%. For the suprasternal notch, detection rate dipped to 87%. Processing was quick, with an average detection time of 0.52 second.

The neural network was able to detect and localize the key features even in visibly asymmetrical breast reconstructions. The high success rate confirmed that the training data set was sufficient, with no need for data augmentation techniques.

“Neural networks and machine learning have a potential of improving the evaluation of breast symmetry in the field of plastic surgery, by automated and quick detection of features used by surgeons in practice,” Kenig and his coauthors conclude. They believe that, with further advances in image detection capabilities and their applications to breast surgery, neural networks could play a role in evaluation of breast symmetry and planning of both aesthetic and reconstructive plastic surgery.

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