Invisible Underwear GalaFLEX

GalaFLEX new breast support material

With the advancement of modern medical technology, the demand for breast plastic surgery has been increasing year by year. According to the International Society of Aesthetic Plastic Surgery(ISAPS) 2023In the statistical data of the year, breast lift surgery ranks fifth among female cosmetic surgeries, while breast augmentation ranks first; these figures indicate the high importance women place on the aesthetics and health of their breasts. Against this backdrop,GalaFLEXAs an emerging breast support material, it is gradually becoming the preferred choice for plastic surgeons and patients due to its unique advantages.

GalaFLEX is a biodegradable support material mainly used in breast plastic surgery, especially in breast lifting and augmentation surgeries. The material is synthesized from natural bacteria.P4HB（Poly-4-Hydroxybutyratemade, with excellent biocompatibility and strength; from2015Since its first application in the United States,GalaFLEXrapidly gained widespread use globally, including in the United States, Europe, the United Kingdom, Australia, and South America, and has2023Year introduced to Taiwan.
Tifeng Gorgeous Princess Repair Patch, Medical Device Registration No. 036252, commonly known as: Invisible Bra

GalaFLEXTechnical Advantages

GalaFLEXThe core advantages lie in its strong support and superior tissue integration performance; these characteristics enableGalaFLEXBecome the ideal choice for soft tissue support and repair in breast plastic surgery.

1. Strong support

   GalaFLEXThe support can provide immediate support for soft tissue after surgery, and after implantation.12Still maintain about during the week70%the strength. This lasting support helps prevent post-operative breast sagging and reduces the need for corrective surgeries; clinical studies have shown thatGalaFLEXThe support provided by the implant is far greater than that of autologous tissue, even reaching that of natural tissue.2-4倍。

2. biodegradability

   GalaFLEX is a biodegradable material, in18至24It gradually decomposes within a month and is ultimately expelled from the body in the form of water and carbon dioxide through natural physiological pathways. This characteristic allows forGalaFLEXNo need for secondary surgeries to remove it like traditional synthetic materials, reducing the burden and risk for patients.

3. Promote tissue growth

   the mesh structure of the GalaFLEX support has large pores, providing ample space for the ingrowth of new tissue. Only two weeks after implantation,GalaFLEXThe support can achieve more than surrounding tissues.75%the degree of integration, promoting microvascular regeneration and the formation of connective tissue; this accelerated tissue integration performance helps shorten the recovery time for patients and improve the success rate of surgeries.

4. low infection risk

   由於GalaFLEXAdopting a single-strand structure design, this structure has a smaller surface area, making it difficult for bacteria to adhere and hide, thereby reducing the risk of infection. This characteristic is especially important for breast surgery patients, as infections can not only prolong the recovery period but may also lead to more serious complications.

5. No chemical residues, suitable for sensitive individuals.

   GalaFLEX is made from natural materials, contains no animal proteins, and has no chemical residues, making it a safe choice for patients who are sensitive to materials or have special requirements.

Why do soft tissues need GalaFLEX support?

• As we age, after the age of 20, collagen in the skin will decrease by 1% each year.
• Many factors can accelerate the loss effect: gravity, menopause, smoking... various factors.
• Clinical studies have shown that within 10 years after plastic surgery, 32-48% of patients will undergo a second surgery to modify their initial results—most commonly due to soft tissue weakness or defects, which are the reasons behind these secondary surgeries.

 

 

GalaFLEX invisible underwear

GalaFLEX is a biodegradable support material primarily used in breast plastic surgery, especially in breast lifting and augmentation procedures. This material is made from P4HB (Poly-4-Hydroxybutyrate) synthesized by natural bacteria, featuring excellent biocompatibility and strength. Since its first application in the United States in 2015, GalaFLEX has rapidly gained widespread use globally, including in the United States, Europe, the United Kingdom, Australia, and South America, and was introduced to Taiwan in 2023.

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GalaFLEX applicable audience

GalaFLEXThe wide range of applications makes it an ideal choice for various breast plastic surgeries. Here are several that are particularly suitable for useGalaFLEX的情境：

1. Placing oversized breast implants (>350 c.c.): Patients with oversized breast implants are prone to implant displacement after surgery, which is caused by the soft tissue's inability to support excessive weight.GalaFLEXProvides strong support, helping to reduce or avoid the occurrence of this situation, thereby improving the stability and long-term effects of the surgery.
2. Postpartum breast sagging: Postpartum women often face the issue of breast sagging due to breastfeeding and hormonal changes in the body; GalaFLEX can effectively improve the shape and position of the breasts by strengthening soft tissue support, restoring a youthful appearance.
3. Breast sagging after rapid weight loss: Rapid weight loss can lead to a quick loss of fat and soft tissue in the breasts, resulting in noticeable sagging; for these patients, the support of GalaFLEX can help shape and stabilize the breast's appearance, making it look more natural and fuller.
4. Repair of complications from breast augmentation surgery: Some complications may occur after breast augmentation surgery, such as implant sliding, displacement of the implant, or bilateral communication (i.e., a communication phenomenon between the two breasts); in these cases,GalaFLEXIt can serve as an important tool in repair surgeries, ensuring that the implant remains in the correct position by reinforcing soft tissue.

GalaFLEX can be applied in surgery

Any tissue that requires soft tissue reinforcement is suitable for GalaFLEX.

• General breast augmentation surgery
• Breast augmentation surgery / Breast reduction surgery
• Reconstruction requirements: implant descent, implant displacement, bidirectional communication.

GalaFLEX features

• Low chemical residues and no animal proteins
• Low infection rate and rapid tissue growth
• Strong immediate support of regenerated tissue
• biodegradable

GalaFLEX immediate support strength

GalaFLEX single-strand structure

• The mesh-like large pore structure provides sufficient space for tissue ingrowth, accelerating microvascular regeneration and the repair of soft tissues, achieving a bonding degree of over 75% with soft tissues within 2 weeks.
• The single-strand mesh has a smaller surface area, which results in fewer recesses for bacteria to hide, evading the body's natural defense system and the effects of antibiotics.

P4HBWhat is it?

P4HB is a fully absorbable bio-derived polymer.

GalaFLEX support is a porous monofilament scaffold made from Poly-4-Hydroxybutyrate (P4HB), which is a fully absorbable bio-derived polymer made from the monomer 4HB. 4HB is a naturally occurring human metabolite found in the brain, heart, liver, kidneys, and muscles.GalaFLEX support will gradually degrade as expected within 18 to 24 months and will be expelled from the body in the form of water and carbon dioxide through natural physiological pathways.

Reference1.Camila Utsunomia, Qun Ren, and Manfred Zinn: Poly(4-Hydroxybutyrate): Current State and Perspectives. Front Bioeng Biotechnol. 2020; 8: 257.

GalaFLEX large pore mesh provides a growth scaffold

GalaFLEX support is implanted in the human body for breast fixation surgery, and microscopic examination of the tissue cross-section after six weeks.

：1. .Williams SF, Martin DP, Moses AC. The History ofGalaFLEXP4HB Scaffold.AesthetSurg J. 2016;36(suppl 2):S33-S42. doi:10.1093/asj/sjw141.

Microscopic examination of tissue cross-section 7 months after the placement of GalaFLEX support for breast fixation surgery.

：1. .Williams SF, Martin DP, Moses AC. The History ofGalaFLEXP4HB Scaffold.AesthetSurg J. 2016;36(suppl 2):S33-S42. doi:10.1093/asj/sjw141.

GalaFLEX strong material

• Provides immediate support for soft tissue after surgery, retaining 70% of its strength even 12 weeks post-implantation.
• According to preclinical studies, the strength of rapidly regenerated tissue is 2-4 times that of autologous tissue.

GalaFLEX strengthens new tissue

GalaFLEX internal journey

• Immediate post-operative: provides internal support for new tissue and space for inward growth.
• 2 weeks: There is a binding degree of >75% with the tissue.
• 1 month: Healthy cells gradually migrate from the scaffold to form new tissue.
• 1 year: The newly formed tissue will provide better support and stability, and it has been proven to provide 2-4 times higher strength than natural tissue.
• 1.5-2 years: The mesh scaffold is basically completely absorbed and is converted into water and carbon dioxide through physiological pathways for excretion from the body.

GalaFLEX product model and size

Post-operative care precautions for GalaFLEX

• Post-operative massage
  Within one month after surgery, patients should avoid massaging the breasts. This period is an important stage for the integration of the GalaFLEX support with the surrounding tissue, and it is necessary to allow sufficient time for natural integration. Premature massage may affect the position and function of the support, thereby impacting the results of the surgery. After one month, patients can gradually begin gentle massages, but they should follow the doctor's guidance and avoid excessive force.
• Postoperative foreign body sensation
  For patients with thinner skin, there may be a foreign body sensation after surgery, which usually lasts for 3 to 6 months. Over time, patients will gradually adapt, and the foreign body sensation will lessen; if the sensation is too strong, it is recommended that patients communicate with their doctor in a timely manner to ensure there are no other potential issues.
• Suture tension issue
  During the surgical process, if the sutures are too tight, it may lead to postoperative discomfort. Therefore, special attention should be paid to the suturing technique during the surgery to ensure comfort and safety. If persistent discomfort occurs after the surgery, professional medical advice should be sought in a timely manner.

GalaFLEX is changing the traditional breast augmentation surgery methods.

GalaFLEX, as an innovative breast shaping material, is changing the traditional methods of breast surgery with its advantages of strong support, biodegradability, and low infection risk, providing many patients with stable and aesthetically pleasing breast shapes. If you are considering breast augmentation or lifting surgery, choosing GalaFLEX means choosing longer-lasting support and a more comfortable experience. If you would like to learn more about whether GalaFLEX is suitable for you, please contact Enherya to embark on a journey towards a more beautiful and comfortable surgical experience.

Indications

This product is an accessory for sutures, used for reinforcement and repair of weak soft tissue, suitable for breast surgery patients who require additional reinforcement materials to achieve the desired surgical results. This product is used in medically necessary breast surgeries when the existing soft tissue is insufficient to support the surgical repair, facilitating the repair and reinforcement of soft tissue; for example, in breast reduction surgeries and secondary breast surgeries performed to correct conditions. This product is also suitable for breast cosmetic surgeries.

Function

This product degrades through hydrolysis and hydrolytic enzyme digestion.
This product minimizes the differences in absorption rate and strength through research and development, providing full support throughout the expected healing phase.
Preclinical implantation tests indicate that the GalaFLEX patch can retain about 70% of its support strength at 12 weeks.
Basically, the patch material will be completely absorbed within 18-24 months.
The 3DR three-dimensional frame series may have a tactile sensation at the outer edge during the entire expected healing phase.

Contraindications

Since this product is completely biodegradable, it should not be used in repair situations where permanent support is needed.

警告

1. The manufacturing of the product involves exposure to tetracycline hydrochloride and kanamycin sulfate. The safety of patients allergic to these antibiotics and the use of the product remain unknown.
The safety and efficacy of this product in neural tissue and cardiovascular tissue have not yet been established.
The safety and efficacy of this product in pediatrics have not been established.
4. It is not recommended to place the patch in direct contact with the intestines or internal organs.
5. If an infection occurs, please seek active treatment. If the infection is not resolved, it may be necessary to remove the patch.
6. This product is supplied in a sterile condition. Please check the product and packaging before use to ensure that the packaging is intact.
7. This product is for single use only. Do not re-sterilize or reuse any part of this product. To avoid the risk of cross-infection or reduced performance, do not reuse even if the product appears to be in good condition. The patches cannot be re-sterilized. All unused patches from opened packaging should be discarded.
8. Unused patches must be disposed of according to the institution's procedures for handling biohazardous materials.
9. Any decision regarding the removal of the patch should consider the potential risks associated with secondary surgery, which may include difficulties in removing the patch due to tissue ingrowth or degradation of the patch. Appropriate postoperative management should follow the removal of the patch.

Precautions

Only physicians with appropriate surgical qualifications can use this product. Users should be familiar with the surgical procedures and techniques, including support requirements and patch size selection. Incorrect selection, placement, positioning, or fixation of the patch may lead to adverse outcomes. Patients should be provided with instructions regarding postoperative care, including weight lifting, personal hygiene, activity restrictions, and other specific patient/surgical requirements. This product is biodegradable, so the initial tactile sensation caused by the patch will decrease over time.

GalaFLEX Ministry of Health and Welfare Medical Device License

Ti Feng Gui Li Fei Repair Patch Medical Device License No. 036252