Understanding the clinical, scientific and technological terms often times used to discuss silicone gel-filled breast implants and breast implant surgery can be helpful when making a decision about whether to have breast implant surgery, as well as what the best surgical procedure and implant is for you. Below, you will find definitions (listed in alphabetical order) for many of the terms used in the literature, by physicians, and referred to on this site to discuss breast implant surgery.
- Adjunct Studies
Ongoing research studies of reconstruction and revision patients eligible for silicone gel-filled breast implants.
- Aesthetic
Of, or relating to beauty.
- American Academy of Pediatrics
An organization of 60,000 U.S. pediatricians committed to the attainment of optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults.
- Analysis Study
- Anesthesia
-
Drugs given to reduce or prevent pain during a surgical or other medical procedure. There are four main types of anesthesia:
- Local: numbs one small area of the body.
- Conscious or intravenous (IV) sedation: uses a mild sedative to relax the patient and a pain medicine to relieve pain.
- Regional anesthesia: blocks pain in an area of the body, such as an arm or leg.
- General anesthesia: anesthesia which affects the whole body, putting the patient to sleep with no memory of the medical procedure following.
- Animal Studies
A laboratory experiment using animals to study the development and progression of diseases. Animal studies also test how safe and effective new treatments are, before they are tested in humans.
- Areola
The pigmented or darker colored area of skin surrounding the nipple of the breast.
- Asymmetry
Lack of proportion of shape, size, and/or position between the two breasts.
- Autoimmune Disease/Disorder
A disease in which the body mounts an “attack” response to its own tissues or cell types. Normally, the body’s immune mechanism is able to distinguish clearly between what is a normal “self” substance and what is foreign. In autoimmune disease, this system becomes defective and mounts an attack against normal parts of the body, causing tissue injury. Certain diseases such as rheumatoid arthritis, lupus, and scleroderma are considered to be autoimmune diseases. There is no evidence of an established link between autoimmune disease and silicone gel-filled breast implants.
- Barrier Layer
An additional silicone layer found in the outer shell of the breast implant.
- Baseline mammogram
This is the first mammogram that a woman has and is used by her physician as a comparision against subsequent mammograms to check for changes in the breast.
- Bias
A statistical sampling or testing error caused by favoring some outcomes over others.
- Biocompatibility
Being compatible with living tissues or systems, without being toxic.
- Bleeding
A loss of blood due to an open break in the skin, through a natural opening in the body, or an internal breaking of a blood vessel.
- Board-Certified Surgeon
A surgeon who has completed the process of board certification in a specialty field from an accredited association, such as the American Society of Plastic Surgery.
- Body Dysmorphic Disorder
A mental disorder characterized by preoccupation with, and distress about slight or imagined defects in one's physical appearance.
- British Independent Review Group (BIRG)
Committee of the United Kingdom’s Department of Health established to review the evidence relating to the possible health risks associated with silicone gel-filled breast implants, to examine the issues relating to pre-operative patient information, and to report to the Chief Medical Officer on its conclusions.
- Breastfeeding
The feeding of an infant at the mother's breast.
- Breast Augmentation Surgery
A surgical procedure to increase breast size. Augmentation is one of three clinical uses approved for silicone gel-filled breast implants by the United States Food and Drug Administration (FDA).
- Breast Reconstruction Surgery
A surgical procedure to replace breast tissue that has been removed due to cancer or trauma, or that has failed to develop properly due to a severe breast abnormality. Reconstruction is one of three clinical uses for silicone gel-filled breast implants approved by the United States Food and Drug Administration (FDA) in November 2006.
- Breast Revision Surgery
A surgery performed to correct, improve or replace an existing breast implant. Revision is one of three clinical uses approved for silicone gel-filled breast implants by the United States Food and Drug Administration (FDA).
- Cancer
An abnormal growth of cells that tend to proliferate in an uncontrolled way and, in some cases, to spread (metastasize).
- Capsule
Scar tissue which forms around the breast implant. Sometimes this capsule squeezes around the implant, resulting in a condition known as capsular contracture. Also referred to as fibrous capsule.
- Capsular Contracture
A tightening of the tissue capsule surrounding an implant resulting in pain, firmness or hardening of the breast, and in squeezing of the implant, if severe.
- Capsulectomy
Surgical removal of the scar tissue capsule around the implant.
- Case Report
A detailed report of the diagnosis, treatment, and follow-up of an individual patient, including demographic information about the patient, such as age, gender, ethnic origin.
- CC
Cubic Centimeter: Related to the volume/size of breast implants.
- Clinical Study
A type of research study that tests how well new drugs, medical devices or medical approaches work in people.
- Cohesiveness
The firmness of a breast implant created by the cohesive properties of the implant filler. In the case of silicone gel-filled breast implants, the cohesiveness is created by the tight cross linking bonds of the silicone gel molecules.
- Cohort Study
A study in which two groups (also referred to as “cohorts”) of patients are followed over time and compared to each other. For example, a cohort study might follow a group of women with silicone gel-filled breast implants, comparing specific health metrics and assessments against those of women who do not have implants.
- Confounding Factors
Outside factors and variables that are not being examined as part of a study, which can influence the main focus of the study and distort the results.
- Connective Tissue
The material found between cells that gives tissues form and strength.
- Connective Tissue Disease/Disorder (CTDs)
A disease, group of diseases, or conditions affecting connective tissue, such as muscles, ligaments, skin, etc. and/or the immune system. CTDs that involve the immune system include rheumatoid arthritis, lupus, and scleroderma. The published studies show there is no consistent pattern of association of silicone gel-filled breast implants with a risk of developing CTDs.
- Contraindication
A use of a product, procedure or device that is improper and should not be followed. Failure to follow contraindications identified in the labeling could cause serious harm.
- Control Groups
A group of individuals participating in a study or clinical trial that are not given the agent or device which the study is examining, but rather are given a placebo or sample. The control group is identical in size and make up to the group receiving the agent or device being examined in the study, and establishes the baseline for results.
- Core Clinical Studies
The primary clinical study of breast augmentation, reconstruction, and revision (revision-augmentation and revision-reconstruction) in patients, which supported the approval of a premarket approval (PMA) application. Safety and effectiveness data are collected yearly through 10 years. Follow-up from years 5 through 10 will be performed as part of a post-approval Core Study.
- Current Good Manufacturing Procedures (CGMP)
Regulations which must be followed by pharmaceutical, medical device and biotech firms to ensure that their products meet specific requirements for identity, strength, quality, and purity.
- Device Tracking
A program intended to facilitate the ability to notify women with silicone gel-filled breast implants in the unlikely event that a particular implant device is recalled. Device Tracking provides women an additional reassurance that a breast implant manufacturer can locate them through their physician, if an issue is suspected with their implants.
- Displacement
Movement of the implant from the usual or proper place.
- Elastomer
An elastic material also known in some cases as a rubber. A silicone elastomer is very different chemically from organic rubbers and is unrelated to latex.
- Electrocardiogram or EKG
A test that detects and records the electrical activity of the heart. An EKG is used to detect and locate the source of heart problems by determining how fast the heart is beating, the rhythm, and where in the body the heartbeat is being recorded.
- Epidemiologic Study
A scientific study which examines the causes, distribution and controls of a disease or condition in a population.
- European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM)
A European organization which examines the use of medical devices, products and technologies to ensure that those used in plastic surgery are safe for patients.
- Explantation
Procedure during which a breast implant is removed with or without replacement.
- Extracapsular Rupture
A type of rupture in which the silicone gel is outside of the scar tissue capsule surrounding the implant.
- Fibromyalgia
A disorder characterized by chronic pain in the muscles and soft tissues surrounding joints, with tenderness at specific sites in the body. It is often accompanied by fatigue. The published studies show that silicone gel-filled breast implants are not significantly associated with a risk of developing Fibromyalgia.
- Fibrous Capsule
A layer of connective tissue which naturally develops in the human body around any internal organ or implanted medical device.
- Fold Flaw Failure
A tear or hole in the shell of a silicone gel-filled breast implant caused by repeated flexing or friction at the site of a crease or wrinkle in the shell caused by surgical error or manufacturing defect. Studies have shown that fold flaw failure is a rare occurrence and is not a significant cause of implant rupture.
- Healing Process
The time taken for the body to undergo the natural process of repairing itself following injury or surgery.
- Implant Malposition
Implant malposition or displacement is when the implant is not in the correct spot in the breast. This could be due to incorrect placement of the implant during the surgery or due to shifting of the implant position over time.
- Immune System
See Immunology.
- Immunology
The study of the immune system, a collection of different processes in the body that protect us from harmful substances and disease by seeking out and destroying anything that is "foreign," including viruses and bacteria.
- Immunosuppressive Therapy
Therapy used to decrease the body's immune system response, such as drugs given to prevent transplant rejection.
- Infection
Invasion with microorganisms (for example, bacteria, viruses). An infection usually results in fever, swelling, redness and/or pain.
- Institute of Medicine (IOM)
A division of the United States National Academy of Sciences that provides science-based advice on matters of biomedical science, medicine and health. In 1999, the IOM released a landmark 400-page report, entitled "Safety of Silicone Breast Implants," which concluded that women with silicone gel-filled breast implants demonstrate no higher incidence of specific health conditions (connective tissue diseases, cancer, neurological disease and other systemic conditions) than women without silicone gel-filled breast implants.
- International Agency for Research on Cancer (IARC)
The IARC is a component of the World Health Organization whose mission is to coordinate and conduct research on the causes of human cancer, the mechanisms of carcinogenesis, and to develop scientific strategies for cancer control.
- Intracapsular Rupture
A type of rupture in which the silicone gel remains inside the scar tissue capsule surrounding the implant.
- Intravenous or I.V.
Literally, "within a vein," intravenous is the giving of medications or fluids through a needle or tube inserted directly into a vein, allowing immediate access to the blood supply.
- Investigational Device Exemption (IDE)
An authorization by the FDA to allow an unapproved medical device to be used for investigational purposes.
- Lactation
The production and secretion of milk by the breast glands.
- Lactation Insufficiency
An inadequate production of natural breast milk through the lactation process.
- Lupus
A disease in which the body produces antibodies that attack its own organs. The published studies show that silicone gel-filled breast implants are not significantly associated with a risk of developing lupus.
- Lymph Nodes
Structures in the lymphatic system that act as filters to keep particulate matter like bacteria from entering the bloodstream. They may also stop cancer cells and help the body’s immune system.
- Mammography
A type of X-ray examination of the breasts used for detection of cancer.
- Mastectomy
-
The removal of breast tissue due to the presence of a cancerous or precancerous growth. There are five types of mastectomy:
- 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 a sampling of lymph nodes.
- Radical Mastectomy: surgical removal of the entire breast, including the nipple, areola, and overlying skin, as well as the pectoral muscles, lymph nodes, and other neighboring tissue. Rarely, if ever performed.
- Skin-Sparing Mastectomy: surgical removal of cancerous tissue through an incision around the nipple and areola, rather than cutting across the entire breast. Promises less scarring.
- Meta-analysis
The process or technique of summarizing research results by using various statistical methods to retrieve, select, and combine results from previous separate but related studies.
- MRI
Magnetic Resonance Imaging. A radiographic examination that has the best ability to detect rupture of silicone gel-filled breast implants.
- National Cancer Institute (NCI)
A division of the National Institutes of Health, the NCI is the United States Federal Government's principal agency for cancer research and training.
- National Institutes of Health (NIH)
A part of the United States Department of Health and Human Services, the NIH is the primary Federal agency for conducting and supporting medical research.
- Neurological Disease
Disturbance in structure or function of the central nervous system resulting from developmental abnormality, disease, injury or presence of toxins in the body.
- Nipple Sensation
The sensitivity and feeling felt through the nipple and surrounding areola.
- Oncologist
A doctor who studies, identifies and treats cancer.
- Outer Covering or Shell
The external covering of a silicone gel-filled breast implant made from silicone elastomer and designed to hold the silicone gel. Today’s silicone gel-filled breast implants have a thick outer shell, a silicone patch and a silicone barrier material covering the entire surface.
- Peer-Reviewed and Published Reports
Academic studies and reports which have been subjected to analysis and review by other experts in the same field.
- Periareolar
Around the darkened or pigmented area surrounding the nipple of the breast.
- Periareolar Breast Augmentation Technique
Breast augmentation where the plastic surgeon inserts the breast implant through an incision around the areola, the pigmented or darker colored area of skin surrounding the nipple of the breast. Many women have found that this technique creates less noticeable scarring.
- Plastic Surgery
Surgery intended for the improvement of appearance of the body.
- Platinum
A metal used as a catalyst in the manufacture of the shell and gel components of silicone breast implants. Studies have demonstrated that the type of platinum found in silicone gel-filled breast implants in very small quantities is metallic platinum, similar to that found in approved medical devices, rather than the form of platinum that is more active in the body, platinum salts.
- Pointer, Sam
Federal judge who, in 1996, appointed an independent scientific panel to assist the court in examining information about silicone gel-filled breast implants. The panel concluded that studies do not show a link between silicone gel-filled breast implants and disease.
- Postoperatively
After surgery.
- Pre-clinical Studies
Research using animals to find out if a drug, medical device, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.
- Prospective Study
A study in which the subjects are identified and then followed forward in time.
- Psychotropic Drugs
A group of medications used to treat a wide range of mental diseases.
- Radiation Therapy
The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors.
- Re-operation
Any additional surgery following the first breast implantation that involves the breast – including a breast biopsy (used to look for changes in the cells in the breast) or repositioning of the breast implant. There may be one or more reasons for having a re-operation (additional surgery after the primary or revision breast augmentation or reconstruction).
- Response rates
The ratio of the number of people who answered a survey, divided by the number of people addressed in the total study, usually expressed in the form of a percentage.
- Retrieval and analysis studies
Studies undertaken by medical researchers on implantable devices retrieved after removal or revision surgery, to assess their condition after implantation.
- Rheumatoid Arthritis
An autoimmune disease that causes inflammation specifically around the joints. The published studies show that silicone gel-filled breast implants are not significantly associated with a risk of developing rheumatoid arthritis.
- Rheumatological Disease/Disorder (Also called Rheumatism)
A variety of diseases involving connective tissue structures of the body, especially the joints and fibrous tissue. These diseases are often associated with pain, inflammation, stiffness, and/or limitation of motion of the affected parts. They can include autoimmune diseases. Fibromyalgia is a rheumatological disorder. The published studies show that silicone gel-filled breast implants are not significantly associated with a risk of developing rheumatism.
Click here for expert content on rheumatological disease/rheumatism
- Rupture
A tear or hole in the implant shell. Silicone implant ruptures may be silent (no symptoms) or symptomatic. Ruptures can be intracapsular or extracapsular. Some factors that can increase the chances for breast implant rupture include increasing age of the implant, trauma, compression during mammography, and damage by surgical instruments.
- Saline
A solution that is made up of water and a small amount of salt. The United States Food and Drug Administration (FDA) approved saline-filled breast implants for continued access to women in the United States in May 2000.
- Scarring
A permanent patch of fibrous tissue that grows over a wound and replaces the normal skin as part of the natural process of wound repair. Scarring occurs after every wound to the skin following accident, disease or surgery. Scars are often thicker, as well as pinker, redder or shinier, than the rest of your skin.
- Scar Revision
A surgical procedure to improve the appearance of a scar.
- Scleroderma
An autoimmune disease of the body's connective tissues, marked by thickening of the skin, which can affect the internal organs as well. The published studies show that silicone gel-filled breast implants are not significantly associated with a risk of developing scleroderma.
- Selection Bias
An error in choosing the individuals or groups to take part in a study. Ideally, the subjects in a study should be very similar to one another and to the larger population from which they are drawn (for example, all individuals with the same disease or condition). If there are important differences, the results of the study may not be valid.
- Seroma
A build-up of the watery portion of the blood in a tissue location.
- Shell
See Outer Covering.
- Silent Rupture
A breast implant rupture without symptoms and which is not apparent except through appropriate imaging techniques such as MRI. Most silicone gel-filled breast implant ruptures are silent.
- Silicon
A component of the pure silicone molecule.
- Silicone
A man-made material that can be found in several forms such as oil, gel, or rubber. Silicone is used in many medical devices and products, including pacemakers, baby pacifiers and breast implants. The United States Food and Drug Administration (FDA) approved silicone gel-filled breast implants in November 2006.
- Study Protocols
The methods and procedures decided upon at the onset of a study and adhered to throughout all points of the testing, data collection and analysis.
- Study Size
An adequate number of people enrolled in a study to allow researchers the ability to determine a pattern and eliminate the potential that the individuals included in the study are outside of the norm.
- Subglandular Placement
Placement of a breast implant underneath and within the breast glands but on top of the chest muscle.
- Submuscular Placement
Placement of a breast implant wholly or partially underneath the chest muscle. Submuscular placement is generally associated with longer surgeries and recovery times.
- Systemic
Pertaining to or affecting the body as a whole.
- Thrombosis
Clotting of the blood in any part of the circulatory system, as in the heart, arteries, veins, or capillaries.
- Tissue Expander
An adjustable implant that can be inflated with saline to stretch tissue at the mastectomy site, to create a new tissue flap for implantation of the breast implant.
- Toxicology/toxicological
The study of the adverse effects of chemical and physical agents on living organisms.
- United States Food and Drug Administration (FDA)
The U.S. government agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics and products that emit radiation.
- United States Institute
of Medicine - United States Pharmacopeia (USP)
The official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.
- World Health Organization (WHO)
The directing and coordinating authority for health within the United Nations system.
- X-ray
A high-energy electromagnetic wave able to penetrate most solid matter and to act on photographic film, used for detecting or treating cancer.
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This Website last modified October 25, 2007.
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