DefyGravityTM Implant
The novel DefyGravity breast implant device is an anatomically-shaped, either silicone gel- (cohesive or highly cohesive) or saline-filled, tall implant with a smooth shell surface.
The patented DefyGravity™ breast implant is the FIRST breast implant designed to mimic the anatomy and aesthetic configuration of natural breast fatty tissue; based on non-spherical configuration with a flat base that converge towards the chest wall and no axis of rotation, therefore, overcomes the need for texturing and can have a smooth surface.
DefyGravity is a tall implant, it can have a vertical height that is 1-5 cm more than its width to directly fill the upper breast.
DefyGravity is characterized by a personalized medial angle for a narrow medial cleavage, can be filled with saline, cohesive or highly cohesive silicone gel, and can be manufactured in a range of dimensions, sizes, or styles.
Why Breast Implant Shape is Important?
implant shape is the single most important factor that determines how the breast will look after augmentation and reconstruction surgery.
The implant shape is largely determined by the design and configuration of the device used. Currently, there are two implant shapes, the round breast implant from the sixties designed as a compressed sphere, and teardrop anatomical implant from the nineties designed to mimic “mature” breast.
After 3 decades, Apex LLC. introduces DefyGravity™ as a third breast implant shape.
6 Ways DefyGravity™ is Different
There are essential differences between the physical characteristics and configuration of the DefyGravity breast implant and the current round or teardrop-shaped breast implants.
It is the combined action of these features that will result in a superior pleasing natural breast; one cannot obtain a good result by neglecting any of these design characteristics.
These differences underlie DefyGravity ability to improve on breast upper pole aesthetic outcomes, overcomes current design-related, local-breast aesthetic complications, and to avoid texture-associated lymphoma.
1. Tapered Upper Edge
2. Personalized Medial Angle
3. The Tallest Breast Implant
4. Anatomical Implant with Smooth Shell Surface
5. Built-in Proportionate Fill Distribution
6. Relocated Center of Gravity
1 Tapered Upper Edge
DefyGravity features a thin and tapered upper edge that seamlessly transitions to the surrounding chest
DefyGravity upper portion is formed by a slopping front surface intersects the flat base configured to form a tapered upper edge,
wherein an angle between the front surface and the back surface at the upper edge is acute,
Wherein the slopping front surface is either straight or convex.
The dome-shaped, rounded upper edges of current breast implants often result in a contour break in the upper breast that requires thick tissue coverage and camouflaging.
What is the clinical advantages of the thin tapered edges?
- The straight/convex anterior slope make it possible is highly desirable by most patients,*
- Needs little soft tissue coverage,
- Overcomes the step-off deformity of the post-operative breast,
- Avoid very rounded, overfilled breast upper pole associated with round implants,
- Avoid subtle breast upper pole associated with teardrop implants,
- Improves the aesthetic performance of the device by being naturally wrinkle-proof.
2 Personalized Medial Angle
The DefyGravity implant improves on medial cleavage by offering a customized and personalized medial cleavage angle that is better accommodated under the sternal origins of the pectoralis major.
The DefyGravity personalized medial angle have a range of 45o- 85o that snuggly fit under the sternal origins of pectoralis major for a narrow cleavage as demonstrated by the figure on the left.
The thick, rounded medial edges of current breast implants often result in wide medial cleavage.
3The Tallest Breast Implant
The DefyGravity breast implant’s vertical height is unlinked to its width. Its height can be as much as 1-5 centimeters more than its width, as patients anatomy allows.
Raising the breast upper border is desired by the patients to create the “push up” effect, but it is very difficult to achieve with current breast implants because implant vertical height is shorter than what is required by the patient's breast footprint dimensions.
All breast implant manufacturers have designed a "tall implant" to meet the market need of improved breast upper pole fullness, but current tall anatomical implants can only be 0.2-1cm taller than wide (as shown in Annex I below). Hence, current anatomical implants provide a less desirable breast upper pole fullness.
What are the Anatomical Basis for a taller implant?
- Because the breast extends between the 2nd and 6th ribs with the nipple-areola complex situated at the 4th intercostal space the footprint length above the nipple is almost twice that below the nipple, and there is a need for a taller implant.
The implant height determines the implant base shape. When the implant width is fixed, the taller implant will have a paraboloid-shaped base. DefyGravity is the tallest implant design and its base mimic the natural breast paraboloid footprint for an improved aesthetic performance.
Methods of Measurement
Implant height for a particular patient can be estimated by two methods:
- Breast footprint dimensions: the upper border of the breast footprint can be visualized by pushing the breast towards the chest wall and is located at the level of the costal angle. The distance between the footprint upper border and the inframammary fold (IMF) is measured and used to determine the implant height.
- Mathematical proportions: Leonardo Da Vinci is credited with defining an “ideal” proportions of the human figure; setting the ideal ratio of height to width as 1.6 (known as the Golden Ratio). The figure on the left demonstrate that the ratio of DefyGravity height (3X) divided by its width (2X) is 1.5, that is very close to the Golden Ratio.
A second mathematical equation is by dividing the implant vertical height by a point that represents the center of gravity (COG) (#10 in the figure above), then we divide the longer part above the COG by the whole length of the implant the result should close to the Golden Ratio: 3X/2X= 1.5
DefyGravity can be manufactured in a matrix of incrementally increasing acceptable heights that can be varied to meet the needs of a particular patient.
What are the Clinical advantages of a taller implant?
- Simply overcomes the insufficient fullness of the upper breast,
- Raising the breast upper border is desired by the patients to create the “push up” effect,
- Is crucial for creating an attractive shape by the surgeons,
- Avoid a low-breasted postoperative shape,
- DefyGravity implant is configured to fit snugly into the chest surgical pocket, leaving no unfilled (dead) space at the top under the pectoralis major origins. This clinical advantage is depicted here and is compared to the unfilled space caused by state-of-the-art breast implants that leave an unfilled space at the top of the surgical pocket that will eventually become fibrosed and will distort the breast contour.
The figure on the right compares DefyGravity height and snuggly fit to current breast implants.
4Anatomical Implant with Smooth Shell Surface
DefyGravity is the FIRST anatomical implant with a smooth shell surface. This is possible because of its non-spherical configuration, hence It features a flat implant base and no axis of rotation.
"Go smooth or go home" 2
Why smooth is better than textured shell surface?
It is well known that the surgical placement of anatomical textured breast implants are technically demanding. They are not for every surgeon — or every patient.
Teardrop shaped anatomical breast implant have a tendency for malrotation; distorting the breast shape and needs revision surgery. Hence, surface texturing, i.e., making the shell surface rough, was invented to keep the implant in position.
The resultant combination of a highly cohesive silicone gel filling and a textured surface resulted in a breast implant that is time consuming and highly technical, with many plastic surgeons being hesitant to transition to these devices:
- Larger surgical incision is required,
- Implant placement is almost always through the inframammary incision,
- Pocket dissection should be “hand in glove” to exact pocket dimensions, with meticulous hemostasis, the pocket must be opened to the exact shape desired inferiorly and medially, blunt dissection should not be performed,
- Intraoperative sizing is not recommended,
- Surgeons should be sure to place the implant in its desired final position; no setting of textured teardrop implants postoperatively.
Top
What’s more, the FDA has linked implant shell surface texturing with a rare type of cancer.
The market is now dominated by the round (textured and smooth) silicone-filled breast implants.
DefyGravity arrives in a market with a high, unmet need for an anatomical device with a smooth shell surface.
DefyGravity combination of cohesive silicone gel filling and a smooth surface can make surgical placement of the implant an easy procedure for all surgeons.
DefyGravity Have No Tendency to Rotate or Displace
It is unlikely that a pyramid-shaped implant will have a tendency to rotate or be displaced; and can have a smooth shell surface. Certain mechanics of the design to keep the implant in place, including:
Wedge mechanics--the implant edges can be pushed “to-the- point”, hence are fixed in place under the narrow origins of pectoralis major muscle. Pectoralis contractions will have a mechanical fixing effect by pressing the implant towards the breast footprint.
Relaxed implant footprint converging on the rib cage fits like a hand-in-glove inside the surgical placement pocket, creating an air-tight room that hold the implant in situ against gravitational pull and against rotational forces.
Optionally, if the mechanics are not sufficient, i.e., big implants, surgical fixation is an option.
5 Built-in Proportionate Fill Distribution
The advancement of aesthetic science mandates a proportionate pleasing post-augmentation breast form, and the patients became better educated that breast augmentation and reconstruction is not about increasing the breast size.
Current breast implants have not been designed for this aesthetic goal, but DefyGravity have a built-in proportionate fill distribution.
DefyGravity relocate the fill volume where it is needed.
DefyGravity shell configuration and dimensions allows proportionate fill distribution wherein the fill volume of the upper part of the implant (U) (above the implant highest point or the profile) is slightly less than the lower part of the implant (L), and the aesthetically desirable U/L pole ratio of 45/55 percent can be achieved as shown in the figure on the left.
In addition, DefyGravity implant design redistribute the fill volume wherein, within a fixed implant volume, the thin tapering implant periphery holds lesser amount of the fill than current round and teardrop implant; and more fill volume is shifted to the center to produce a higher implant profile within the same implant size mimicking perky young breasts.
The ratio of the implant edge thickness to the implant profile in DefyGravity is 1/9, while it is approximately 1/3 in round implants and 1/5 in teardrop implants.
6 Relocated Center of Gravity
It is the relocated center of gravity that lies behind the trade name DefyGravity.
Wherein locating the center of gravity of the body closer to the back surface than to the front surface reduces deflection of the body in response to gravitational pull on the implant.
Center of gravity (COG) also known as the "center of mass", describes a point at which the entire weight of an object may be thought of as centered, so that if supported at this point the object would hold itself in equilibrium in any position .
DefyGravity Static Balance
A ballet dancer maintains a static balance when she places her body center of gravity in a vertical position above her toes. The same physics applies to DefyGravity’s relocated center of gravity.
The figure on the right compares the location of DefyGravity COG versus current breast implants (reference below).
The figure on the right compares DefyGravity "relocated center of gravity" to current breast implants
REFERENCES
- Umar Choudry. Breast Implants – Current Insights on a common Medical Device. J Surg Open Access 2016; 2(4): doi http://dx.doi.org/10.16966/2470-0991.128
- Lisette Hilton. Breast implants uncovered. September 20, 2016. http://cosmeticsurgerytimes.modernmedicine.com/cosmetic-surgery-times/news/breast-implants-uncovered?page=0,1Last visited March 2017.
ANNEX I
