DefyGravity™ Design Trials

Each breast implant has its own physical characteristics and, hence, reshapes the breast in a different way.

With a goal of producing preliminary data on the aesthetic performance of DefyGravity design, Dr. Al-Jasim at Apex LLC. have conducted a series of design trials to mimic outcomes of breast augmentation and lift. 

DefyGravity effectiveness outcomes include: gain in bra cup size, increase in chest circumferential measurement, and “before” and “after” photographs. 

The figure on the right demonstrate some effectiveness measures used in the patent and in comparative study of DefyGravity vs. Purlz™ implant sizer visualizing the differences between their aesthetic performance.

What is Effectiveness, and How to Measure It?

Effectiveness refers to satisfaction of patient expectations in the 

size and shape of the augmented breast. 

Commonly used effectiveness outcomes are increase in breast size as measured by cup size and circumferential chest measurements. Changes in shape is communicated by photographs.

Here, we will refer to breast augmentation and lift only because the use of DefyGravity in breast reconstruction share similar grounds.

In Clinical Trials

Effectiveness assessment include changes in breast size, as measured by: 

  • Increase in bra cup size,
  • increase in chest circumferential measurement.

These measures were used in the Core Studies and Long-term follow-up studies for the FDA-approved Allergan1-7, Ideal Implant8-9, Mentor10-11, and Sientra breast implant 12-13. In addition, patient and investigator satisfaction scores were used in the U.S. clinical trials.

The long-term post-approval studies of Eurosilicone 14, Motiva 15 and Sebbin16 does not include effectiveness outcomes.  

In Pre-operative Consultation

A. The surgeons and patient select the best implant size that meet patients expectations and is suitable for the patients anatomy based on :

  • Rice test (placing bag of rice with pre-measurd volume in the bra),  
  • Implant sizers (placing a sizer of known volume in the bra).

B- A photograph brought to the consultation by the patient to communicate the desired breast shape, i.e., the "desired look": whether she want a rounded breast with rounded upper pole, vs. subtle upper pole; and What a "bigger" breast means to the patient.

In DefyGravity Design Trial

A- In Apex design trial, the increase in breast size  was measured by the previously-identified outcomes, including:

  • Increase in bra cup size, 
  • Increase in chest circumferential measurements. 

B- A photograph was taken with DefyGravity implant prototype placed in the bra to communicate the shape, i.e., the “new look” produced bt DefyGravity breast implant.

Materials and Methods

Photography: in this study, the characteristic aesthetic outcomes of using DefyGravity breast implant are "visualized" and communicated by photographs.

Before- and after-insertion photos with the model “trying on” different sizes of DefyGravity breast implant prototype in frontal and lateral views are shown. The goal is to imitate the “new look” of using DefyGravity breast implant in breast augmentation and lift-augmentation surgeries.

Effectiveness Assessment: The trial was designed based on pre-operative consultations performed by surgeons with their patients in preparation for breast augmentation. The assessment criteria used to assess changes in the shape of the breast are: fullness of breast upper pole, upper pole slope, implant reach to upper breast border, upper pole to lower pole ratio, medial cleavage, and gain in bra cup size. In the comparative study, the characteristic “new look” in clothes of DefyGravity breast implant vs. commercially available round implant sizer is compared.

The Models: The first model is a young female who lost breast volume after weight loss. Currently bra cup B. She is wearing either a black bra with the desired cup size D, or a fitted black top with deep V neck. She inserts DefyGravity implants under her bra on both sides to imitate breast augmentation. The second model is a multiparous women using DefyGravity breast implant to imitate breast lift. Both models signed a consent to the study.

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The Mold: is specifically constructed to create an implant having the above-identified physical characteristics of our patented “pyramid-shaped breast implant” design.

DefyGravity Prototype: During different phases of the design trial we use a device prepared from TAP Quick Cast Plastics, a platinum silicone cured in the mold as shown in the figure on the right. 

First Design Trial

Aesthetic Performance of DefyGravity™ Breast Implant in         Breast Augmentation 

In this design trial the aesthetic performance of two DefyGravity protypes with different sizes and dimensions is visualized using frontal and 3/4 view photographs.

 In the first modeling DefyGravity prototype with a volume of 540cc, width 12 cm, height 17 cm and a profile of 5.2 cm inserted into a desired bra cup D on both sides. The prototype dimensions were suitable for the chest and breast anatomy of the model.

Figure 1 (before) demonstrates the native breast size and shape in frontal view; figure 2 (after) demonstrates the aesthetic performance of DefyGravity breast implant in frontal view, and figure 5 demonstrates the implant performance in 3/4 view.

In the second modeling the prototype used was made from blue gel with a volume of 350cc, a width of 11.5 cm, a height of 17 cm and a profile of 2.5 cm; the prototype was inserted under fitted black top with a V neckline.

Figures 3 (before) is the native breast, figure 4 (after) with the blue implant in frontal view and figure 6 is a lateral view to demonstrates the aesthetic performance of the blue DefyGravity prototype.

Effectiveness Outcomes

Include the following 3 outcome measures:

 A- Increase in bra cup size,

B- Circumferentioal bust measurements produced by different sizes of DefyGravity breast implant. The results was An unprecedented increased upper pole projection measured by above-bust circumference, wherein the 500 cc DefyGravity implant resulted in an increment of 6 centimeter, and the 350 cc DefyGravity 4.4 cm. ​Results are shown in table 1 below.

C- Frontal and lateral view photographs.

Frontal View Photographs:

Unique outcomes of using DefyGravity implant include: 

  1. Voluminous upper pole, with the upper pole volume approaching lower pole volume

  2. High-breasted look where the implant base sit on the whole of the breast footprint

  3. Ample narrow medial cleavage along the breast bone 

Second Design Trial

Comparative study of DefyGravity™ vs. Round Breast Implant Sizer

Materials and Methods

In this study, the aesthetic performance of a blue gel DefyGravity prototype was compared to a commercially available PurlzTM round breast implant sizer used in pre-operative clinical consultation. The comparison is based on the "look" of the same model placing either 350 cc DefyGravity prototype of 350 cc or Purlz sizer under a fitted black top with deep V-neck.

The photographs used are figure 3 and 4 from the first design trial (referred to as figure A and B respectively), and new figure C that demonstrate Purlz sizer 

Effectiveness Outcomes

In addition to the observations described in the first clinical trial, some additional outcomes are described below:

A. Native Breast

Demonstrating the model's native breast size and shape.

 

 

 

 

 

 

 

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B. DefyGravity Prototype

  1. Full top with full bottom

  2. Young, high-breasted look,

  3. Maintained V-neckline; gravity defying property,

  4. Gentle curved breast outer border, 

  5. Ample narrow medial cleavage,

  6. Natural pleasing outcomes,

  7. Comment: DefyGravity superior performance.

C. Purlz Sizer (representing current round breast implant) 

  1. Shallow top with full bottom,

  2. Mature, low-breasted look,

  3. Distorted V-neck; gravitational downward displacement,

  4. Bulging breast outer border,

  5. Wide medial cleavage,

  6. Augmented unnatural look.

Third Design Trial

Aesthetic Performance of DefyGravity Breast Implant in            Breast Lift-Augmentation 

Anatomical changes of ptotic breast

It is a loss of breast volume, mostly in the upper breast, resulting in an empty skin envelop combined with a streched skin. 

The fatty tissues filling the breast is lost due to loss of weight, breast feeding or aging leaving an empty envelop and extra skin above the nipple level. 

The nipple lies at or below the level of the inframammary fold and the parenchyma sag below its level. 

Can implant design be the answer to ptotic breasts?

The mechanics of an implant that can provide that extra lift for the ptotic breast should target the underlying anatomical changes.

DefyGravity volume distribution is characterized by: 1-Fill the empty envelop of the breast upper pole in sufficient volume and upward direction 2- Push the nipple forward with a slight angulation upward, and 3- while filling the breast lower pole pushing it forward and upward. 

Let us see the outcomes of DefyGravity design trial in breast lift, and judge whether it can improve on the aesthetic outcomes of surgery. 

DefyGravity Prototypes

In this study, two DefyGravity prototypes with different sizes and dimensions were used to demonstrate the performance of DefyGravity implant in lifting, shaping and augmenting the ptotic breast.

Figure 8 demonstrates a frontal view of a mature women (second model) using DefyGravity implant prototype with a volume of 540 cc, implant width 12 cm, height 17 cm, and a profile of 5.2 cm. The implant is placed on top of the left breast with its profile at the nipple level, and its top at the breast upper boundary, just below the pre-axillary crease. The right breast showing Grade III Regnault ptosis.

Figure 9 demonstrates a frontal view of the first model using DefyGravity prototype with a volume of 390 cc, implant width 10.5 cm, height 15 cm, and a profile of 5 cm placed on the left breast with its profile at the nipple-areola complex and its top at the breast upper boundary. The right breast showing Grade I Regnault ptosis.

​Effectiveness Outcomes

Frontal View Photographs:

  1. The implant base is flat, sitting on the anterior thoracic cage that become narrower on the top making the implant base to be slightly tilted upward and forward.

  2. Sufficient implant fill volume is located in the breast upper pole pulling the extra skin and nipple upward and forward.

  3. There implant have no tendency to descend under the effect of gravity because its “center of mass” is resting close to the chest wall.

 

Method of Surgical Use of DefyGravity™ Breast Implant

 

Flexible Options for Surgical Use

Indications: DefyGravity breast implant is claimed for use in: 

A-  Breast augmentation

B-   Breast reconstruction 

C-  Breast lift-augmentation

 Surgical options includes:

Incision Options: periareolar, inframammary or transaxillary. 

Location of the Implant Pocket: The pocket into which DefyGravity implant will be placed can be in one of two positions submuscular or subglandular.

DefyGravity implant Placement: The DefyGravity breast implant is designed to smoothly fit into the surgical pocket.

DefyGravity is designed for easy placement because DefyGravity is characterized by: i-  tapered edges, ii- flat base and iii-smooth shell.

References

  1. Allergan, Inc. Silicone Gel-Filled Breast Implants, Premarket Approval Application (PMA) Number P020056: FDA Summary of Safety and Effectiveness Data (SSED). Date of FDA Notice of Approval: November 17, 2006. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020056b.pdf. Accessed October 20, 2018.
  2. Allergan Inc. Gel-Filled Mammary Prosthesis, Natrelle 410® Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant. Premarket Approval Application (PMA) Number P040046. Date of FDA Notice of Approval February 20, 2013. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040046b.pdf. Accessed October 20, 2018.
  3. Allergan, Inc. Approval for Inspira Cohesive Silicone-Filled Breast implant Filled with Highly-Cohesive Silicone Gel. PMA Supplement. Regulation Number: 878.3540. Decision Date: 09/22/2016Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020056S034. Accessed October 20, 2018.
  4. Bradley P. Bengtson, et al. Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plast. Reconstr. Surg, 2007; 120 (Suppl. 1): 40S. 
  5. Maxwell G. Patrick Maxwell;Van Natta Bruce W. Bengtson Bradley P.; Murphy Diane K. Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study. Aesthetic Surgery Journal
2015; 35(2): 145–155.

  6. Effectiveness data George J. Picha, Navin Singh, Diane K. Murphy. Natrelle Silicone Breast Implant Follow-up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 5000 Reconstruction Subjects. Plast Reconstr Surg Glob Open 2015;3:e489; 
  7. Mark L. Jewell, James L. Jewell.A Comparison of Outcomes Involving Highly Cohesive, Form-Stable Breast Implants From Two Manufacturers in Patients Undergoing Primary Breast Augmentation. Aesthetic Surgery Journal, 1 January 2010; 30 (1):51–65.
  8. Ideal Implant, Inc. Saline-filled Breast Implant. Premarket Approval Application (PMA) Number: P120011FDA Summary of Safety and Effectiveness Data (SSED). Date of FDA Notice of Approval:November 14, 2014. https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120011B.pdf 
  9. Larry S. Nichter, Robert A. Hardesty, Gregg M. Anigian. Ideal Implant Structured Breast Implants: Core Study Results at 6 Years. Plast. Reconstr. Surg,2018 Jul; 142(1): 66–75.
  10. Mentor Corporation. SiliconeMemoryGelTMSilicone Gel- Filled Breast Implants, Premarket Approval Application (PMA) Number P030053: FDA Summary of Safety and Effectiveness Data (SSED). Date of FDA Notice of Approval: November 17, 2006.https://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053b.pdf
  11. Mentor® Memory GelTM Breast Implants and Mentor® MemoryGelTM Xtra Round Breast Implant, Product Insert Data Sheet. Effective September 2017. http://www.mentorwwllc.com/Documents/112017-001RevA_Lo-res_050317.pdf. 
  12. Sientra, Inc. Silicone Gel-Filled Breast Implants Premarket Approval Application (PMA) Number P070004: FDA Summary of Safety and Effectiveness Data. Date (SSED): Date of FDA Notice of Approval: March 9, 2012. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf7/p070004b.pdf. Accessed October 20, 2018.
  13. 12 Steven WG, Calobrace MB, Alizadeh KR, Harrington JL, d’Incelli RC. Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel. Sientra Shaped and Round Cohesive Gel Implants. Plast Reconstr Surg. 2018 Apr;141(4S): ):7S-19S. 
  14. Frank Duteille, Michek Rouif, Sophie Laurent, et al. Five-year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants. Plastic Reconstr Surg Lonb Open 2014; 2(4): e138.
  15. Marcos Sforza, Renato Zaccheddu, Angelo Alleruzzo, et al. Preliminary 3-Year Evaluation of Experience With SilkSurface and VelvetSurface Motiva Silicone Breast Implants: A Single-Center Experience With 5813 Consecutive Breast Augmentation Cases. Aesthetic Surgery Journal 2017, 1–12. https://www.researchgate.net/publication/319715756_ 
  16. Robert El-Hadda, a Béatrice Lafarge-Claoue, Charles Garabedian, Sylvia Staub. A 10-Year Prospective Study of Implant-Based Breast Augmentation and Reconstruction (Sebbin). Eplasty 2018; 18:e7.

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