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IPS Implants® Transformation

Individual Patient Solutions

IPS Implants® Transformation

In daily interactions with the public, the face is the main visible feature determining gender. For many transgender individuals who undergo gender-affirming surgery, facial transformation surgery is, therefore, an important step on their path to gender confirmation.

In facial transformation surgery, various surgical procedures are combined to reduce typical male facial features and thus give the face a more feminine appearance (facial feminization surgery) or to enhance typical female facial features to make them appear more prominent and masculine (facial masculinization surgery).

With IPS Implants® Transformation, we offer a selection of high-quality, individualized guides and implants that enable precise bony modifications with reproducible results for facial gender-affirming surgery. The possible impact is highlighted by numerous benefits such as reduced complication rates, improved esthetic and functional results, shortened surgical time, and faster rehabilitation.

Individual virtual planning

Individual virtual planning

Every case is planned individually in close cooperation between the surgeon and our IPS® Design Engineers. Thanks to a wide variety of planning options, the desired postoperative result can be simulated precisely. Planning, manufacturing, and shipping are all managed in one system.

3D-printed cutting, marking, and drill guides

3D-printed cutting, marking, and drill guides

The virtual planning is transferred to the OR with 3D-printed guides. The guides facilitate rapid and precise modifications of gender-specific facial characteristics through the exact determination of the virtually planned cutting lines, implant positions, and screw holes.

Custom-made implants and onlays

Custom-made implants and onlays

Custom-made implants and onlays from various materials are available to address the individual anatomical situation as specifically as possible. Onlays are used for maxillary and mandibular augmentation to make facial characteristics appear more prominent or defined.

Frontal sinus fixation with SonicWeld Rx®

Frontal sinus fixation with SonicWeld Rx®

Resorbable implants from our Resorb x family can be applied to fix the anterior table after frontal sinus setback. The fixation via our SonicWeld Rx® provides stable fixation and eliminates the need for an implant removal in the forehead region.

Realization options

IPS® Implants Transformation | Facial Feminization Surgery

Individual Patient Solutions - IPS
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What our clinical partners say

Dr. Changmin R. Yim | New York, NY, USA

Dr. Jim Bradley | New York, NY, USA

"Just like any person, trans-women have the right to live their “authentic self.” FFS is an important step in having public perception match the desired gender."

Dr. Jim Bradley has performed well over 100 facial transformations. In an interview, he gave insights into the patient’s pre- and post-surgical regimens and how IPS® planning and guides enhance the user’s experience and result.

 

 

 

Dr. Changmin R. Yim

Dr. Chang Min Richard Yim | Warren, New Jersey, USA

"The use of IPS Implants® Transformation has been fundamental in implementing FFS for my patient base. It allows me to plan a complex surgery ahead of time, provides insight into critical anatomic structures, and allows me to predict what is feasible to achieve. It helps reduce surgical time, and in a busy practice, can help organize and structure patient care."

 

 

 

Dr. Ioannis Chatzistefanou

Dr. Ioannis Chatzistefanou MD, PhD, FACS | Thessaloniki, Greece

"The IPS Implants® Transformation system is a valuable benefit in the repertoire of any surgeon performing Facial Feminization Surgery. It makes forehead, supraorbital rim, zygoma, genio, and mandible angles transformation more precise, fast, and secure."

 

 

Read the whole interview with Dr. Jim Bradley

What inspired you to begin performing facial feminization surgery (FFS)? 

Surgical techniques of FFS are a natural extension of my training and career in craniofacial surgery and cosmetic surgery. I love the marriage of soft and hard tissue procedures in modifying facial features. More importantly, I was drawn to this patient population. Just like any person, trans-women have the right to live their “authentic self.” FFS is an important step in having public perception match the desired gender. 

Can you walk us through your experience with performing FFS prior to implementing IPS® planning for these procedures and the benefits that planning now provides? 

My first FFS procedures were without IPS® planning. As a result, those FFS procedures took longer; I felt the outcomes could be improved.  

I already had transitioned my orthognathic surgery procedures to IPS® planning with guides and custom plates. So, I was comfortable trying to plan FFS procedures with the KLS Martin engineers. Right from the beginning, I knew IPS® planning was the way to go. Along the way, we have made adjustments and improvements. With IPS® planning, one can appreciate the variations in patient anatomy and plan for that before the surgery. 

We also scientifically studied IPS® planning for FFS in the bioskills lab and found it was safer, more efficient, and more accurate. You can find more information to the study here

How does the patient’s pre-surgical work look like? 

At the initial consultation, the surgeon and patient discuss how long their transition has been taking place. Before consideration of FFS, patients should be transitioning at least one year and preferably more than two years. They should also consistently be on hormonal therapy for the same amount of time. Hormone replacement therapy will have a beneficial effect on appearance, particularly with hair growth and skin/soft tissue changes. However, bony structure changes are much less likely once skeletal maturity occurs (by age 15-16 years). As for the next step, patient preference of areas for facial feature modification is discussed. In today’s era of social media platforms and online information, the patient typically has a good idea as to the features that are commonly modified during FFS. Common facial features that most patients request at initial consultation are brow recontouring and lifting, nasal reshaping, and jawline tapering. In addition, cheek augmentation, tracheal shave, and other regions may also be requested.  

Subsequently, a full evaluation from top to down is performed: hairline to brow distance, degree of supraorbital and forehead projection, nasal radix location, nasal shape, intranasal and intraoral (dental) inspection, mandibular angle width and masseteric activity, chin shape, and thyroid cartilage projection in the neck. 

After that, full facial images are taken along with 3D images. Vectra 3D image software morphing may be helpful in discussing rhinoplasty and genioplasty changes. 

Then a 3D CT scan is ordered (1 mm cuts from apex to hyoid). The disc is obtained and sent to KLS Martin for IPS® planning. 

Finally, at the pre-operative visit, the specific details of facial feature modification are discussed. At times, patients may alter the plan after consideration from the initial visit. The KLS Martin IPS® plan (guides and custom plating) and 3D images are reviewed. Procedure risks and post-operative instructions are given. 

What kind of guides are used, and what are their advantages as opposed to working without one? 

There are three different kinds of guides: the frontal sinus/supraorbital, osseous genioplasty, and mandibular angle titanium cutting guide. Let me guide you through their respective function and advantages. 

Frontal sinus/supraorbital guide: The center of this guide outlines the anterior wall of the frontal sinus. This allows for confidence in performing an osteotomy around the border of the anterior wall of the frontal sinus. There are also markings to delineate the septum of the frontal sinus. After the osteotomy of the frontal sinus wall, a thin osteotome is directed along the septal mark to complete the removal of the bone. In addition, there is a horizontal mark that delineates the most projected portion of the convex surface. This is used in making the horizontal cut across the frontal sinus once the bone has been removed. A resorbable plate is then molded (by hot water) on a pre-made clear skull model that has been modified to create a flat forehead. Frontal sinus bone pieces are secured to this resorbable plate and returned to cover the frontal sinus.

Steps to performing a frontal sinus setback

Osseous genioplasty drill and marking guide: This guide is used to mark the genioplasty horizontal osteotomy and central chin bone for removal. It also has predictive holes for the custom plate. After degloving the anterior chin, the drill and marking guide is placed based on the anterior mandibular occlusion. Screw fixation is used, and drill holes are made. A Reciprocating saw is used to cut the central bone (typically 6 mm) for removal. The horizontal osteotomy is marked as planned well below the inferior alveolar/mental nerve. After down fracture, an additional thin wedge of bone angled lateral is removed for chin shortening. The customized plate is then used for centralizing the two halves of genioplasty segment in an advanced position. The degree of advancement is based on surgeon preference at planning.

Steps to performing the chin reduction

Mandibular angle titanium cutting guide: This is used to cut the mandibular angle and narrow the lower face. It is based on molar occlusion. After stripping masseteric attachments, the guide is placed and fixated to the anterior ramus with a 9 mm screw. A VRO oscillating saw is used with lighted irrigation. The saw uses the guide to “see and feel” the cut. After scoring the osteotomy, the guide is removed, and ostectomy is completed. Masseteric attachments are stripped, and bone is removed. Contour burring is performed to finalize the lateral mandibular contouring.

Occlusal based guides are used to guide the resection of the mandibular angles

Can you walk us through post-operative consults and the noticeable psychological changes in your patients?

After FFS (performed mostly in one stage), patients typically stay in the hospital for one to two nights. After their stay in the hospital, they are asked to follow their written instruction while home and return to the office a week after FFS for their first post-operative visit. Nasal splint and sutures are removed. Swelling tends to peak in 48 hours but may take two weeks to reside. Although the profound change will be noticed almost immediately, the final result may take months. 

After some time, patients adjust psychologically, which is shown in them looking forward again to wearing their makeup and styling their hair once they recover from FFS. It helps when they have friends to reach out to, that have gone through the same procedure. For other patients, we provide patient support with phone calls and texting.

If you are interested in viewing before and after images, please visit Dr. Bradley’s website: https://www.jamespbradleymd.com/facial-feminization-surgery-new-york-city/

Are you able to share any insight into your referral process?

Frequently, referrals occur from within the transgender community itself. A satisfied FFS patient will often refer several friends for consultation. Local and regional transgender care facilities will refer patients directly to the office once they get positive feedback from their trans-women clients. Internet searches and social media referrals are other common sources for referrals.

Webinar recording with Dr. Jim Bradley

Watch the recording of the webinar on "Approaching facial feminization/masculinization surgery with IPS Implants® Transformation" with Dr. Jim Bradley now!

Surgical technique | 3 procedures to a complete bony facial feminization surgery

1. Frontal sinus setback and orbital rim contouring

Insertion of the guide

After completing a coronal incision, the frontal sinus and supraorbital guide is fixated with maxDrive® screws.

The center of the guide outlines the anterior wall of the frontal sinus and the septum based on the pre-operative digital planning. A horizontal mark identifies the most projecting part of the convex surface. Furthermore, the guide identifies the areas of orbital rim resection.

Marking of the cutting lines and performing the osteotomy

The osteotomy line for the frontal sinus setback and the burring lines for the orbital rim contouring are defined using the cutting mark. Afterwards, the screws can be loosened again, and the drill guide is removed.

Osteotomy is now performed to mobilize the anterior wall of the frontal sinus. A thin osteotome is directed along the septal mark to complete the removal of the bone.

Cutting the frontal sinus

Once the anterior wall of the frontal sinus has been osteotomized, a horizontal cut across the frontal sinus is made to eliminate the projecting part of the bone.

Burring is performed to finalize the contouring.

Orbital rim contouring

The osteotomy of the orbital rims is completed using a reciprocating saw. Again, burring is performed along the predefined lines to finalize the contouring.

Frontal Sinus Fixation with SonicWeld Rx®

A water bath is used to heat the resorbable implant for anatomic manipulation.

Frontal Sinus Fixation with SonicWeld Rx®

A custom-made skull model of the desired post-op situation is used to adapt the implant to the anatomical situation of the patient and to create a flat forehead.

Frontal Sinus Fixation with SonicWeld Rx®

The bone pieces of the anterior wall of the frontal sinus are secured to the resorbable implant and fixated back on the forehead of the patient to cover the frontal sinus.

The type and extent of postoperative treatment and rehabilitation measures are to be coordinated with the patient by the attending user.

2. Mandible angle reduction

Insertion of the guide

A custom-made gonial angle guide is used to cut the mandibular angle and narrow the lower face. After completing access and stripping masseteric attachments, the guide is placed and fixated to the anterior ramus. 

Gonial angle guides can be provided bone-based or occlusal-based made of polyamide or titanium. Titanium guides can be used as cutting guides to directly perform the osteotomy.

Marking of the cutting line and performing the osteotomy

The osteotomy line is defined using the cutting mark. Afterwards the guide is removed, and the osteotomy is completed using an oscillating saw.

Contouring of the mandible angles

The bone piece is removed. Contour burring is performed to finalize the lateral mandibular contouring.

3. Chin reduction and fixation

Insertion of the guide and marking of the cutting lines

After degloving the anterior chin, the drill and marking guide is placed and fixated. 

The center of the chin bone and a horizontal osteotomy line is marked. The horizontal osteotomy is located as planned well below the inferior alveolar/mental nerve.

The guide also has predictive holes for a custom-made plate.

Drilling and performing the osteotomy

The guide is removed and the holes for the custom-made plate are drilled.

Removing the bone piece

A reciprocating saw is used to cut the central bone. Afterwards, the center of the chin bone is removed.

Fixation of the implant

A custom-made plate is used for centralizing the two halves of genioplasty segment in an advanced position.

The degree of advancement is based on surgeon preference at planning.

Publications

Louis, M., C. Qiu, R. Travieso, D. Marano, and D. Coon. 2022. Computer-aided Planning and Execution in Facial Gender Surgery: Approaches, Concepts, and Implementation. Plastic and Reconstructive Surgery - Global Open 10 (5). https://doi.org/10.1097/GOX.0000000000004330   

Tirrell, A. R., A. A. Abu El Hawa, J. Bekeny, B. L. Chang, and G. Del Corral. 2022. Facial Feminization Surgery: A Systematic Review of Perioperative Surgical Planning and Outcomes. Plastic and Reconstructive Surgery - Global Open 10 (3). https://doi.org/10.1097/GOX.0000000000004210

Hohman, M. H., M. Jastrzembski, N. Choe, M. Nuara, J. Teixeira, and A. Vincent. 2021. 3D-Printed Custom Cutting Guides Facilitate Frontal Cranioplasty in Gender Affirmation Surgery. Journal of Craniofacial Surgery 32 (7). https://doi.org/10.1097/SCS.0000000000007846 

Chen, K., S. M. Lu, R. Cheng, M. Fisher, B. H. Zhang, M. Di Maggio, and J. P. Bradley. 2020. Facial Recognition Neural Networks Confirm Success of Facial Feminization Surgery. Plastic and Reconstructive Surgery 145 (1). https://doi.org/10.1097/PRS.0000000000006342   

Hoang, H., A. A. Bertrand, Anthony, A. C. Hu, and J. C. Lee. 2020. Simplifying Facial Feminization Surgery Using Virtual Modeling on the Female Skull. Plastic and Reconstructive Surgery - Global Open 8 (3). https://doi.org/10.1097/GOX.0000000000002618

Gray, R., K. Nguyen, J. Lee, J. Deschamps-Braly, N. Bastidas, N. Tanna, and J. Bradley. 2019. Osseous Transformation with Facial Feminization Surgery: Improved Anatomical Accuracy with Virtual Planning.Plastic and Reconstructive Surgery 144 (5). 
https://doi.org/10.1097/PRS.0000000000006166

Required osteosynthesis accessories

For surgical treatment with IPS Implants® Transformation the following osteosynthesis accessories are required:

  • Sufficient number of KLS Martin osteosynthesis screws in the planned diameters and lengths
  • A screwdriver suitable for the planned osteosynthesis screws
  • A drill suitable for the planned osteosynthesis screws
  • SonicWeld Rx® with resorbable implants (SonicPins Rx and Resorb x meshes) for frontal sinus fixation

Explanation of terms

Identity labels mean different things to different people. The following links are intended to serve as a tool and guide.

Legal basis for IPS Implants®

According to the regulation (EU) 2017/745, a custom-made product is a device specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

For this reason a separate inquiry is necessary in every IPS® case.

The written prescription is a release for the technical offer (design of the products). This is to be submitted in writing by the user at the same time as the required order for the economic offer if he/she agrees with the desired case planning.

Shipment is not permissible as a matter of principle without this mandatory regulatory document.

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