Motiva Learning - Medical Terminology

Adipose Tissue

Fat tissue that surrounds and cushions the mammary glands and ducts, giving the breast its shape and size.

Animation Deformity

Caused by contraction of the pectoralis muscle against the breast implant, causing it and the overlying breast shape to unnaturally shift toward the axilla with muscle contraction.

Areola

The circular, pigmented area surrounding the nipple.

Asymmetry

Uneven appearance between a woman's left and right breasts in terms of size, shape, or breast level.

Axillary Lymph Nodes

Lymph nodes located in the armpit area that drain lymph fluid from the breast and surrounding areas. They are important in breast cancer staging and treatment planning.

Barrier Layer

Motiva Implants® have a barrier layer. The barrier layer within the shell of a silicone gel-filled breast implant is designed to mitigate the diffusion of silicone gel through the shell.

BIA-ALCL

Is not breast cancer; it is a rare type of non-Hodgkin’s lymphoma, a cancer involving the cells of the immune system.

Biocompatible

Chemical characterization studies and biocompatibility studies according to current ISO 10993 standards demonstrate that Motiva SmoothSilk® Round and Motiva SmoothSilk Ergonomix® breast implants are nontoxic and suitable for their intended use.

BlueSeal

A visual indicator of the implant shell barrier layer that confirms the integrity of the implant shell designed for quality assurance and patient safety.

Breast Augmentation

Surgical procedure to increase the size of the breasts using implants or fat transfer.

BIA-ALCL

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)

Breast Reduction

Surgical procedure to reduce the size of the breasts by removing excess fat, tissue, and skin.

Breast Reconstruction

Surgical procedure to rebuild a breast mound after mastectomy or lumpectomy.

Breast tissue preservation

During breast augmentation or mastopexy-augmentation involves minimally invasive techniques and creating the pocket through controlled mechanical retraction aided by tumescent dissection, adhering to anatomical landmarks to avoid disrupting the breast's supportive structures. This approach may reduce long-term mechanical stress improving device stability by maintaining the displaced tissue vitality and integrating it with surrounding support, all of which, in combination with local anesthesia, may contribute to faster patient recovery.

C Distance

The arc length measured from the lower pole to the point of maximal projection of the implant.

Capsule

Scar tissue which forms around the breast implant.

Capsular contracture

A tightening of the scar tissue (also called a capsule) that normally forms around the breast implant during the healing process after surgery. In some women, the scar tissue (capsule) squeezes the implant. When this occurs, it is called capsular contracture. This results in firmness or hardening of the breast and is a risk for implant rupture. Capsular contracture is classified by Baker Grades. Capsular Contracture Baker Grades III or IV are the most severe. Baker Grade III often results in the need for additional surgery (reoperation) because of pain and possibly abnormal appearance. Baker Grade IV usually results in the need for additional surgery (reoperation) because of pain and unacceptable appearance. Capsular contracture Baker Grade II may also result in the need for surgery. Each grade is described below.

• Baker Grade I Normally soft and natural appearance

• Baker Grade II A little firm, but breast looks normal

• Baker Grade III More firm than normal, and may look abnormal (change in shape)

• Baker Grade IV Hard, obvious distortion, and tenderness with pain

Capsulectomy

The surgical removal of scar tissue or capsule that has become thickened and hardened around a breast implant.

• En Bloc Capsulectomy An en bloc capsulectomy is performed when the capsule is removed in 1 piece with the breast implant contained inside the capsule

• Total Capsulectomy A total capsulectomy is performed when the entire capsule is removed and usually also the breast implant

• Partial Capsulectomy A partial capsulectomy is performed when small portions of the capsule are moved, usually in addition to the breast implant

Capsulotomy (closed)

An attempt to break the scar tissue capsule around the implant by pressing or pushing on the outside of the breast. This method does not require surgery but may rupture the implant and is contraindicated.

Capsulotomy (open)

An attempt to break the scar tissue capsule around the implant by surgical incision into the capsule.

Density of Peeks

With an average density of 20,000 peaks per cm2,1 the SmoothSilk® surface provides an accessible environment for cell deposition and absorption. According to animal models, in mice and rabbits, a cell compatible peak distribution, allows macrophages and fibroblasts to accumulate in different areas without overloading the surface, avoiding excessive cell agglomeration, thereby optimizing the body’s immune response.

DIEP flap

A type of breast reconstruction in which blood vessels called deep inferior epigastric perforators (DIEP), as well as the skin and fat connected to them, are removed from the lower abdomen and transferred to the chest to reconstruct a breast after mastectomy with minimal or none of the abdominal muscles.

Ducts

Tubes that carry milk from the lobules to the nipple.

Ergonomics as a science

Ergonomics is the scientific field that studies human interaction with other elements of a system. It applies theory, principles, data, and methods into a design that optimizes human wellbeing and overall system performance. The design and technology of Motiva SmoothSilk Ergonomix® implants is based on the science of Ergonomic.

Extrusion

Skin breakdown with the implant pressing through the skin or surgical incision.

Flap

A portion of tissue (which may include muscle, fat, and skin) moved from one part of the body to another. The tissue flap may or may not have its blood supply attached.

Gel bleed

The diffusion of silicone gel through the implant shell.

Gel fracture

Appearance of a fissure or fault line in highly cohesive gel in response to an applied force.

Hematoma

A collection of blood within a space.

Implants Ergonomy

In the context of breast implants, Ergonomy refers to a device designed to adapt, react, feel, and behave like native breast tissue, which allows for an outcome with a more natural look and feel. To be ergonomic, a breast implant should have a round base and mimic natural breast dynamics by adapting to gravitational shifting. Motiva SmoothSilk Ergonomix® implants follow this adaptability concept, which relies on the intrinsic rheological properties of the TrueMonobloc® silicone shell and ProgressiveGel Ultima®, without the need to underfill the device.

Infection

Postoperative complication where bacteria contaminate the surgical site, leading to inflammation, pain, and potential implant removal.

Inframammary

Below the breast.

Kurtosis

Kurtosis is a statistical measurement of the surface that indicates the spread of the peak height distribution. A Kurtosis above 3 refers to a lower variability of the peak heights. SmoothSilk® has an average Kurtosis above, which confirms the uniformity of the surface and demonstrates the controlled and low variation of the manufacturing process.

Latissimus dorsi flap

A type of pedicle flap surgery. It uses muscle, fat, and skin from the upper back that is pulled under the skin to the chest area. The scar on the back can be placed at the bra line to make it less visible. Sometimes an implant is placed during the same surgery to make the breast larger.

Lobules

Small sacs within each lobe of the breast where milk is produced during lactation.

Low bacterial attachment

Bacterial biofilms have been associated with breast implant complications including capsular contracture, double-capsule formation, and BIA-ALCL. Due to their increased surface area, implants with highly textured surfaces may harbor greater biofilm loads than those with smoother surfaces. Due to its low surface area (1.14mm2), the SmoothSilk® surface elicits low bacteria attachment and biofilm formation (based on an in-vitro testing).

Low inflammatory response

A low inflammatory response is a minimal reaction of the body's immune system to the presence of Silicone Breast Implants. It implies that the inflammatory processes associated with the introduction and recognition of foreign materials into the body is less pronounced as compared to other devices tested. The SmoothSilk® surface has been scientifically shown to have a low inflammatory response and may reduce the risk of complications such as capsular contracture.

Low fibrotic capsule

All breast implants will induce the formation of a capsule around the breast implant, this is a normal response to a foreign body. The Motiva SmoothSilk® 4-micron surface is intentionally designed for optimal interaction of the shell surface with the breast tissue, therefore, a resulting low-fibrotic capsule is expected and allows for better adaptability, and a reduced risk of device-related complications, such as capsular contracture and proliferative diseases (BIA-ALCL, BIA-SCC, B-cell lymphomas).

Low friction

Friction between a breast implant's surface and the surrounding tissue is the resistance encountered when these surfaces move against each other. In the context of breast implants, this friction occurs where the implant surface comes into contact with the surrounding tissue, such as the breast capsule, epithelium, or adjacent muscle. Factors such as surface roughness have been shown to influence the level of friction. Excessive friction may contribute to patient discomfort and cell damage. The SmoothSilk® surface elicits low friction between the implant and the surrounding breast tissue, resulting in the maintenance of cellular behavior and no visible cell damage.

Low particle debris

Particles released by silicone breast implants refer to tiny fragments or debris that may be shed from the surface of the implant over time. These particles can consist of silicone molecules, silicone gel, or other materials used during the manufacturing process. The presence of these particles can potentially trigger inflammatory reactions or immune system responses in the body.1 The controlled surface and low surface roughness of the SmoothSilk® 4-micron has been shown to minimize particulate debris.

Lumpectomy

Surgical removal of a cancerous tumor (lump) and a small margin of healthy tissue surrounding it, preserving the breast.

Malposition

When the implant is placed incorrectly during the initial surgery or when the implant has shifted from its original position. Shifting can be caused by many factors, such as gravity, trauma, poor initial placement, and capsular contracture.

Mammary Glands

Glands within the breast tissue responsible for milk production. Each breast contains 15-20 lobes, each composed of lobules that produce milk.

Mammoplasty

Plastic surgery of the breast.

Mastectomy

Partial or complete removal of the breast due to the presence of a cancerous or precancerous growth.

• Subcutaneous mastectomy Surgical removal of the breast tissues, but sparing the skin, nipple, and areola

• Total mastectomy Surgical removal of the breast including the nipple, areola, and most of the overlying skin

• Modified radical mastectomy Surgical removal of the entire breast including the nipple, areola, and overlying skin, as well as the lymphatic-bearing tissue in the axilla.

• Radical mastectomy Surgical removal of the entire breast including the nipple, areola, and overlying skin, as well as the pectoral muscles, lymphatic bearing tissue in the axilla, and various other neighboring tissue

Mastopexy

Surgical procedure to raise and reshape sagging breasts.

Medial

Pertaining to the middle, near the midline of the body.

Migration

Movement of silicone materials outside the breast implant to other parts of the body.

• Intracapsular gel migration Inside the scar tissue capsule surrounding the implant

• Extracapsular gel migration Outside the scar tissue surrounding the implant

Montgomery Glands

Small glands in the areola that secrete oil to lubricate and protect the nipple during breastfeeding.

Morphology

Morphology is the study of breast implant behaviour when exposed to forces exerted by the soft tissue of the chest wall.

Nipple

The projection at the center of the areola through which milk ducts discharge milk during lactation.

Nipple Reconstruction

Surgical procedure to recreate a nipple and areola after breast reconstruction.

Necrosis

Death of cells or tissues.

Palpability

The ability to feel the implant.

Parenchyma

Refers to breast tissue.

Pectoralis Major Muscle

The large muscle underneath the breast tissue that covers the chest wall and aids in arm movement.

Point of maximum projection

The point of maximal projection is the point along the vertical axis of the implant that has the highest projection from the chest wall.

ProgressiveGel® PLUS

The ProgressiveGel® PLUS is a highly cohesive silicone-gel with balanced rheological properties that allows a full and round upper breast pole fullness while maintaining a uniformly round shape.

ProgressiveGel® ULTIMA

The ProgressiveGel® ULTIMA is a highly cohesive silicone-gel with unique rheological properties: low viscosity and high elasticity. This enables enhanced adaptability and responsiveness resulting in a soft consistency and gravitational shifting.

Projection

Projection is measured from the base of the device to the point of maximal projection from the chest wall and is expressed in millimeters.

Ptosis

Sagging or drooping of the breast.

RFID Enabled Implants

The radiofrequency identification device (RFID) platform is an optional non-invasive and magnet-free technology available in the Motiva® portfolio and found in the following devices: 1) Qid® within Motiva Implants®: Enables rapid, accurate device verification and device traceability with personal privacy.1 Motiva Implants® with RFID technology are labeled MR Conditional meaning, patients can safely undergo MRI under the specific labeling conditions.2) The Injection Port within the Motiva Flora® SmoothSilk® Tissue Expander has RFID technology and is labeled MR Conditional, allowing for safe MRI scanning under specific conditions3, improved dosimetry planning with CT scanning,4,5 and the potential for delivering a more precise radiation treatment with lower impact to adjacent tissues. The Flora Injection Port is located using the Port Locator accessory.

Rheology

The Science studies the deformation and flow of complex matter. It aims to understand, model, and predict the behavior of samples of complex matter. It establishes relationships between rheological properties, the molecular structure and the composition of complex matter (e.g. gels and shells).

Rippling

Rippling refers to a palpable or visible fold on the surface of the breast, transmitted from the wrinkling or folding of the underlying breast implant. It is a complication following breast augmentation, and results in significant patient dissatisfaction and high rate of re-operation.

Roughness

Roughness refers to the variations in the height of the surface relative to a reference plane. The SmoothSilk® surface has a controlled surface architecture produced by the mandrel imprinting technique with an average roughness of 4 microns. This unique process provides consistent control of the shell surface and provides a "controlled roughness".

Rupture

A tear or hole in the shell of the implant that allows silicone gel filler material to leak from the shell.

Seroma

Similar to a bruise, a seroma occurs when the watery portion of the blood collects around a surgical incision or around a breast implant.

Shift of volume

The implant gel inside the breast implant shell that shifts from the upper pole to the lower pole, from the horizontal to the vertical position, respectively.

Skewness

The skewness of a surface refers to the predominance of peaks over valleys. A positive skewness indicates a higher presence of peaks, and a negative skewness indicates a higher presence of valleys. Traditional textured breast implants have a negative skewness due to the salt-loss technique that creates an irregular pattern of pores/valleys on the shell surface. Conversely, the Motiva SmoothSilk® Implant surface is characterized by a positive skewness, due to the controlled mandrel imprinting technique.

Silent rupture

A breast implant rupture without symptoms or a visible change. Silent rupture cannot be felt by the woman or detected by a doctor through physical examination. Silent rupture can only be discovered through appropriate imaging techniques such as MRI. Most silicone gel-filled breast implant ruptures are silent.

SmoothSilk 4-micron Surface

SmoothSilk® is a 4-micron surface, designed for enhanced biocompatibility and scientifically shown to promote a low inflammatory response, low friction, and low bacterial attachment resulting in soft breasts, low capsular contracture rates, and no reported primary device-related proliferative diseases (BIA-ALCL, BIA-SCC and B-cell lymphomas).

SmoothSilk® Ergonomix® Implants

Combines the SmoothSilk® 4-micron surface, TrueMonobloc®, BluSeal® and is 100% filled with the ProgressiveGel® ULTIMA. Designed to mimic the look, feel, and movement of a natural breast1,2 while allowing insertion through a smaller* incision. *as compared to SmoothSilk® Round Implant.

SmoothSilk® Round Implants

The SmoothSilk® Round breast implant combines Motiva®’s SmoothSilk® 4-micron surface, TrueMonobloc®, BluSeal® and is 100% filled with ProgressiveGel® PLUS. It is designed for increased upper pole fullness and softness.

Suspensory Ligaments (Cooper's Ligaments)

Fibrous bands that extend from the skin to the deep fascia of the breast, providing support and maintaining the shape of the breast tissue.

Symptomatic rupture

A breast implant rupture that is associated with symptoms (such as lumps, persistent pain, swelling, hardening, or change in implant shape). Some silicone breast implant ruptures are symptomatic, but most are silent.

The unique fingerprint of SmoothSilk®

There are five surface parameters that influence surface topography and define the unique fingerprint of the SmoothSilk surface: Roughness, Surface Area, Density of Peaks, Skewness, and Kurtosis.Based on animal and human models, the unique surface topography of the SmoothSilk® surface has been scienfically shown to promote an optimal foreign body response through the influence of these surface parameters on the inflammatory response as compared to other breast implant surfaces studied.

TrueMonobloc

TrueMonobloc® is the foundation of each Motiva® implant, unifying the shell, patch, and gel into one single unit1 designed to allow and promote the following:

• Surgeons to make small surgical incisions.

• Low device-related complications such as rotation, and rippling, and specifically designed morphologies for desired aesthetic outcomes such as upper and lower pole fullness.

TRAM flap

The transverse rectus abdominus musculocutaneous (TRAM) flap. This section of muscle and tissue consists of the transverse rectus abdominus muscle, skin, fat, connective tissue, and vascular (blood vessels) tissue. It is taken from the abdomen and can be used to create a new breast for reconstruction purposes. A TRAM flap is also sometimes used to add breast tissue and skin to cover a breast implant during reconstruction.

• Free TRAM Flap A TRAM flap that is disconnected from (completely cut away from) the blood vessels in the rest of the body before being relocated to the breast area for reconstruction. The blood vessels must then be surgically reconnected when the flap is placed at the breast

• Pedicle TRAM Flap A TRAM flap that stays connected to the blood vessels in the rest of the body while being relocated (through a tunnel under the skin) to the breast area for reconstruction

Tribology

Tribology is the science that studies how moving surfaces in contact create friction and wear over time1. Tribology is relevant because the local tissue reaction to an implanted device may be influenced by friction and wear.

100% filled vs underfilled

Motiva Implants® are 100% filled. The volume capacity of each Motiva Implant is 100% filled with silicone gel.