GalaFLEX Internal Bra™ Scaffold

Long lasting support
in aesthetic breast surgery14,5,17,25

The tissue issue

Understanding breast changes

Breast sagging or dropping or changes in the shape of the breast occur because the quality of our tissue changes over time, compromising the tissue strength required to maintain the position of the breast1,2,11

As women age, the gradual loss of collagen is what causes skin to become thinner and less elastic, resulting in sagging and wrinkles.1,12

There are
many factors
that can
accelerate
this effect:1,12

Genetics
Gravity
Smoking
Previous surgery
Implant exchange
or removal
Sun & UV exposure
Diet & weight fluctuations
Pregnancies & breastfeeding
Menopause
Body composition

Surgery to correct breast sagging may provide satisfactory results for a while; but ultimately will not change the quality of the tissue.
So, the breast may drop again with time.1,2,11,26 This may result in women feeling unhappy with the breast appearance or wanting further surgery.1,2,11
Reoperation is generally more complex and can add additional cost to the patient.1,2,11

Find my surgeon

Approximately 1 out of 3 of breast surgery women undergo a reoperation.16
Within 10 years following breast surgery, many women undergo a reoperation to revise their initial surgical results, according to clinical studies.16
Nearly half of the revision’s surgeries among aesthetic breast implant patients is due to sagging of the breast.16

Learn about GalaFLEX Internal Bra™ Scaffold

An internal bra is a variety of techniques in breast surgery, that aim to help maintain breast shape and position over time by stabilizing the breast internally.27

Breast surgery with an internal bra is sometimes compared to an internal “push-up” bra or an internal “hammock”.

Clinical studies have shown that GalaFLEX Internal BraTM maintains the shape and position of the breast obtained after aesthetic breast surgery.9,18,24
Immediate support at time of surgery4,17
Promotes production of new collagen and strengthens tissue4,5,7
Leaves tissues 3-4x stronger than prior to surgery4,5,7
Absorbs over the course of 1.5 to 2 years4,3,5

Based on preclinical data on file. Results may not correlate to clinical outcomes.

Learn how the Internal Bra works

Find my surgeon

Watch our
GalaFLEX Internal Bra™ Scaffold
surgeons’ stories

Dr. med. Philipp Braun

Specialist in plastic, reconstructive and aesthetic Surgery Chief Physician at Aestheticum Tübingen

“This testimonial reflects the personal experience of the particular individual providing it and is not intended to be a recommendation or a referral of any device or procedure. This testimonial is not necessarily representative of what anyone else using our products may experience. Neither BD warrants that any of the statements contained in this testimonial are accurate, complete, or will apply to any particular individual’s circumstances. This testimonial may have been edited for clarity or brevity. The person providing this testimonial has not been compensated by BD for their time and effort in preparing this testimonial for BD’s further use and distribution.”

Watch our
GalaFLEX Internal Bra™ Scaffold
womens’ stories

Cristina, Germany

Breast lift
with GalaFLEX™ Scaffold

“This testimonial reflects the personal experience of the particular individual providing it and is not intended to be a recommendation or a referral of any device or procedure. This testimonial is not necessarily representative of what anyone else using our products may experience. Neither BD warrants that any of the statements contained in this testimonial are accurate, complete, or will apply to any particular individual’s circumstances. This testimonial may have been edited for clarity or brevity. The person providing this testimonial has not been compensated by BD for their time and effort in preparing this testimonial for BD’s further use and distribution.”

Ariane, Germany

Breast lift with GalaFLEX™ Scaffold

“This testimonial reflects the personal experience of the particular individual providing it and is not intended to be a recommendation or a referral of any device or procedure. This testimonial is not necessarily representative of what anyone else using our products may experience. Neither BD warrants that any of the statements contained in this testimonial are accurate, complete, or will apply to any particular individual’s circumstances. This testimonial may have been edited for clarity or brevity. The person providing this testimonial has not been compensated by BD for their time and effort in preparing this testimonial for BD’s further use and distribution.”

What women
like about the Bra30

63%

Provides long lasting support and results, even when no longer in the body

52%

Makes the new breast tissue several times stronger

50%

Does not increase the infection risk

49%

Absorbed naturally by the body after about a year

Out of 2038 women surveyed, the top three factors for choosing a surgeon30

Surgeon qualifications reputation

61%

Communication with the surgeon, education provided

38%

Recommended by friends /relatives or a medical practicioner

32%

Results with GalaFLEX Internal Bra™ Scaffold

Before & after

real patients photos

Before and after photos of patients who received GalaFLEX Internal Bra™ Scaffold for soft tissue support during an aesthetic breast procedure. Photos provided courtesy of Doctors. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Internal Bra™ Scaffold is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Breast reduction

GalaFLEX Internal Bra™ Scaffold

Dr Bruce Van Natta, US

Before and after photos of patients who received GalaFLEX Internal Bra™ Scaffold for soft tissue support during an aesthetic breast procedure. Photos provided courtesy of Dr. Van Natta. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Internal Bra™ Scaffold is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Breast augmentation

GalaFLEX Internal Bra™ Scaffold

Dr Bruce Van Natta, US

Before and after photos of patients who received GalaFLEX Internal Bra™ Scaffold for soft tissue support during an aesthetic breast procedure. Photos provided courtesy of Dr. Van Natta. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Internal Bra™ Scaffold is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Breast lift with implant

GalaFLEX Internal Bra™ Scaffold

Dr Bruce Van Natta, US

Before and after photos of patients who received GalaFLEX Internal Bra™ Scaffold for soft tissue support during an aesthetic breast procedure. Photos provided courtesy of Dr. Van Natta. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Internal Bra™ Scaffold is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Breast lift

GalaFLEX Internal Bra™ Scaffold

breast lift
Dr Bruce Van Natta, US

Before and after photos of patients who received GalaFLEX Internal Bra™ Scaffold for soft tissue support during an aesthetic breast procedure. Photos provided courtesy of Dr. Van Natta. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Internal Bra™ Scaffold is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Breast reduction

GalaFLEX Internal Bra™ Scaffold

before and after en
Dr Roy de Vita, Italy

Before and after photos of patients who received GalaFLEX Internal Bra™ Scaffold for soft tissue support during an aesthetic breast procedure. Photos provided courtesy of Dr. Roy de Vita. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Internal Bra™ Scaffold is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Find my surgeon

Find your GalaFLEX Internal Bra™ Scaffold surgeon

Country
  • Germany
  • Greece
  • Italy
  • UK
City
    Download
    the printable questions sheet
    to ask your surgeon

    Frequently asked questions about
    GalaFLEX Internal Bra™ Scaffold

    How does GalaFLEX™ Scaffold work?

    GalaFLEX™ Scaffold, made of P4HB (Poly-4-hydroxybutyrate), is designed to integrate with and strengthen the surrounding tissue.4,5,7
    P4HB promotes the production of new collagen and, as it is absorbed, is replaced by new tissue over time.4,5,7

    Will GalaFLEX™ Scaffold stay in my body forever?

    No, it will be absorbed naturally by your body after 1.5 to 2 years.3,4,5
    It is made of a material that is naturally broken down by the body into C02 and H20.2,3,4,5,8

    Will my breast tissue still be as strong after GalaFLEX™ Scaffold is no longer there?

    Preclinical data has shown that the use of GalaFlex results in tissue that is 4-3 times stronger than before surgery.4,5,7

    Is GalaFLEX™ Scaffold right for me?

    If you are considering an aesthetic breast procedure such as a lift, a reduction, an augmentation, an implant exchange or removal, GalaFLEX™ Scaffold may provide the long-lasting support that you need. Please consult your surgeon to discuss if it may be right for you.3

    Βased on preclinical data on file. Results may not correlate to clinical outcome.

    Consumer should seek an independent medical advice before committing themselves to significant treatments, including those that are physically invasive.

    Intended Use:
    GalaFLEX™, GalaFLEX 3DTM and GalaFLEX 3DRTM Scaffolds are intended for use, as an adjunct to sutures, for the reinforcement and repair of soft tissue where weakness exists and where the addition of a reinforcing material is needed to obtain the desired surgical result in patients undergoing breast surgery. The GalaFLEX™, GalaFLEX 3DTM, and GalaFLEX 3DRTM Scaffolds are designed to be used in patients undergoing soft tissue repair and reinforcement in medically necessary breast surgery procedures where the existing soft tissue is deficient to support the surgical repair. Examples of such breast surgery applications include reduction mammoplasty and breast revision surgery to correct a medical condition. The GalaFLEX™, GalaFLEX 3DTM and GalaFLEX 3DRTM Scaffolds may also be used in cosmetic breast procedures.
    Important safety informations:
    Possible complications following implantation of the GalaFLEX™, GalaFLEX 3DTM, and GalaFLEX 3DRTM Scaffolds include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, and adverse events, consult the specific GalaFLEX™ Scaffold Product Instructions for Use.
    References:
    1. Choi JW, Kwon SH, Huh CH, Park KC, Youn SW. The influences of skin visco-elasticity, hydration level and aging on the formation of wrinkles: a comprehensive and objective approach. Skin Res Technol. 2013;19(1):e349-e355. 2. Vera, Martin. “Phases of Wound Healing: The Breakdown.” Wound Source. Accessed on Nov 13, 2020. 3. GalaFLEX™ Scaffold Instructions For Use. 4. Preclinical data on file. Results may not correlate to clinical outcomes. 5. Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4- hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN Surg. 2013;2013:238067. Published 2013 May 28. 6. Williams SF, Martin DP, Moses AC. The History of GalaFLEX P4HB Scaffold. Aesthet Surg J. 2016;36(suppl 2):S33-S42. 7. Scott JR, Deeken CR, Martindale RG, Rosen MJ. Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair. Surg Endosc. 2016;30(9):3691-3701. 8. Martin, DP, Williams, SF. Medical applications of poly-4-hydroxybutyrate: a strong flexible absorbable biomaterial. Biochemical Engineering Journal. Volume 16, Issue 2, 2003. Pages 97- 105, ISSN 1369-703X, https://doi.org/ 10.1016/S1369-703X(03)00040-8. 9. Mallucci P, Bistoni G. Experience and Indications for the Use of the P4HB Scaffold (GalaFLEX) in Aesthetic Breast Surgery: A 100-Case Experience. Aesthet Surg J. 2022;42(12):1394-1405. 10. Buccheri EM, Villanucci A, Mallucci P, Bistoni G, de Vita R. Synthetic Reabsorbable Mesh (GalaFLEX) as Soft Tissue Adjunct in Breast Augmentation Revision Surgery. Aesthet Surg J. 2023;43(5):559-566. 11. Levenson SM, Geever EF, Crowley LV, Oates JF 3rd, Berard CW, Rosen H. The Healing of Rat Skin Wounds. Ann Surg. 1965;161(2):293–308. 12. Thornton, M. Julie. “Estrogens and Aging Skin.” Dermato-Endocrinology, vol. 5, no. 2, 2013, pp. 264–270., doi:10.4161/derm.23872. 13. G. Patrick Maxwell, MD et al. “Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study.” Aesthetic Surgery Journal 2015, Vol 35(2) 145–155. 14. W. Grant Stevens, MD, et al. “Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.” Plastic and Reconstructive Surgery. April Supplement 2018. 15. Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years. Plast Reconstr Surg. 2017;140(6):1142-1150. 16. Grewal NS, Fisher J. Why do patients seek revisionary breast surgery? Aesthet Surg J. 2013 Feb;33(2):237-44. 17. Martin, D. P., Badhwar, A., Shah, D. V., Rizk, S., Eldridge, S. N., Gagne, D. H.,& Scott, J. R. (2013). “Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research, 184(2), 766-773. 18. Adams WP Jr, Baxter R, Glicksman C, Mast BA, Tantillo M, Van Natta BW. The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study. Aesthet Surg J. 2018;38(5):502-518. 19. Pineda Molina C, Hussey GS, Liu A, Eriksson J, D’Angelo WA, Badylak SF. Role of 4-hydroxybutyrate in increased resistance to surgical site infections associated with surgical meshes. Biomaterials. 2021;267:120493. 20. Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V. “Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacteria adherence, and the in vivo consequences in a rat model.” J Biomed Mater Res. 2002;63(6):765-71. 21. Halaweish, Ihab, et al. “Novel in vitro model for assessing susceptibility of synthetic hernia repair meshes to Staphylococcus aureus infection using green fluorescent protein-labeled bacteria and modern imaging techniques.” Surgical infections 11.5 (2010): 449-454. 22. Engelsman, A. F., van der Mei, H. C., Ploeg, R. J., & Busscher, H. J. (2007). “The phenomenon of infection with abdominal wall reconstruction.” Biomaterials, 28(14), 2314-2327. 23. Deeken CR, Chen DC, Lopez-Cano M, Martin DP, Badhwar A. Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review. Front Surg. 2023;10:1157661. Published 2023 Apr 12. doi:10.3389/fsurg.2023.1157661 24. Nair NM, Mills DC. Poly-4-Hydroxybutyrate (P4HB) Scaffold Internal Support: Preliminary Experience with Direct Implant Opposition During Complex Breast Revisions. Aesthet Surg J. 2019;39(11):1203–1213. 25. Williams, Simon F., David P. Martin, and Arikha C. Moses. “The History of GalaFLEX P4HB Scaffold.” Aesthetic Surgery Journal 36.Suppl 2 (2016): S33–S42. PMC. Web. 1 June 201725. Williams, Simon F., David P. Martin, and Arikha C. Moses. “The History of GalaFLEX P4HB Scaffold.” Aesthetic Surgery Journal 36.Suppl 2 (2016): S33–S42. PMC. Web. 1 June 2017. 26. Cuzalina, A., G. Tolomeo, P., & A. Mañón, V. (2023). Revisions for Complications of Aesthetic Breast Surgery. IntechOpen. 27. Wallace L, Wokes JET. Internal Bra: A literature Review and Sub-Classification of Definitions. Aesthetic Plast Surg. 2024 Sep;48(17):3298-3303. doi: 10.1007/s00266-023-03802-4. Epub 2024 Jan 8. PMID: 38189817. 28. https://www.realself.com/surgical/breast-augmentation/cost; https://www.realself.com/surgical/breast-implant-revision/cost 29. Wallace L, Wokes JET. Internal Bra: A literature Review and Sub-Classification of Definitions. Aesthetic Plast Surg. 2024 Sep;48(17):3298-3303. doi: 10.1007/s00266-023-03802-4. Epub 2024 Jan 8. PMID: 38189817. 30. Data on File. Voice of Patient Blinded Survey conducted by Kantar, March 2024.