breast implants are those who want to be eye candy and are willing to do almost anything to get them done. but theres a chance with i think either saline or silicone of them leaking and possibly causing breast cancer. i agree with everybody who responded before me and say go with the hormones and let them work on your body. even though implants are quick and costly, hormones work the entire body (including the penis) they make you dependent on them for the rest of your life i think. i like b-d cups. anything bigger is nice but could strain your back. if you want to get implants thats your choice but i think you should consider the pros and cons of implants and hormones.
faqs on hormones
Hormone Therapy FAQ
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FAQ: HORMONE THERAPY FOR TRANSSEXUALS
This document contains a list of frequently asked questions and their answers regarding hormone therapy (secondary sexual reassignment) for transsexuals. More generally, this document contains information about gonadal hormones and anti-hormones, so it can be a helpful reference for the treatment of androgen and estrogen-sensitive conditions--for example, certain cancers of the reproductive organs and breasts.
Version 95/03/08
This document is available at:
http://www.savina.com/confluence/hormone/
news:soc.support.transgendered (around the fifth of each month)
news:alt.transgendered (around the fifth of each month)
Please send additions, corrections, and suggestions to valerie@shell.portal.com.
Questions Answered in this Document
1. What are hormones, and how do they work?
2. What effect does female hormone therapy have on a male, and how soon?
3. What effect does male hormone therapy have on a female, and how soon?
4. How are hormones administered?
5. How can the intended effects of hormone therapy be maximized and the dangers minimized?
6. How can one obtain hormones?
7. Are birth-control pills a good source of estrogen?
8. How can lactation be induced?
9. How can a male be neutered without causing feminization?
10. Exactly what hormones are available? What are the details on popularity, dosage, availability, price, contraindications, adverse effects, etc.?
11. Where is there more information about hormones?
Fine Print (Read It!)
Contents copyright 1994 by Valerie Lambert, valerie@shell.portal.com. All rights reserved. Permission is granted to freely redistribute, provided that the entire document (including this copyright notice and all disclaimers) is reproduced intact and without charge (beyond a nominal charge for accessing e-mail, public news, and www in general). Hardcopy or cybernetic redistribution for profit requires negotiation with the author.
The answers in this document are collected from a variety of sources: personal experience, second-hand anecdotes, medical literature, pharmaceutical company advertizement, and verbal advice of medical doctors. Despite the authoritative tone of this document, it is presented for educational interest only, not direct advice. It contains opinions, sweeping generalizations, and at least one mistake. The author is not a medical doctor, and makes no claim or warranty as to the suitability of the information in this document for application to any group or individual. YOU, the reader, take sole responsibility for interpretation and application of this information. Form your own opinions by doing your own research. May your favorite deity permanently curse you if you seriously consider sueing the author for misinforming you.
The endocrine feedback system is intricate, delicate, and poorly understood. Even the experts do not entirely agree on how to best meddle with it. Hormone therapy is fraught with risk as well as promise. Be sure you have fully considered the implications before you start. Work with a medical doctor who is qualified to interpret your signs, symptoms, blood tests, and development in the context of your personal medical history. Do not take hormones that you did not obtain directly from a licensed pharmaceutical distributor; the quality of drugs obtained through other channels is not only suspect, but possibly dangerous--especially those in injectable form.
Notes
The words "female" and "male" refer to the original genetic physical form, not to gender identification.
This document does not address hormone therapy of the individual with an endocrine system disorder.
Retail prices are listed in U.S. dollars and vary widely.
The adverse effects listed in this document are gleaned primarily from drug information sheets and the Physician's Desk Reference (PDR). They are translated from medibabble into English where possible. While this information should not be taken lightly, it should be viewed with slight suspicion, since it is first and foremost advertizement and legal copy from pharmaceutical companies. To attempt to reduce their exposure to lawsuits, they list not only the effects reasonably shown to be caused by the drug during clinical trial(s), but also every other adverse effect that the patients experienced while taking the drug--or any other drug of the same class--whether or not the effect was proven statistically relevant by controlled study for the drug in question. In particular, the reader should not be unduly worried about the mention of increase of body hair and loss of scalp hair from estrogens, nor about increase of body hair and deepening of voice from androgen receptor antagonists and GnRH agonists. Finally, adverse effects are only listed here if they make sense in their application to transsexuals, i.e., adverse effects on uniquely female organs are not listed for drugs intended for male-to-female transsexuals, and vice-versa. One should really read the PDR for the drugs of interest in order to provide context for the adverse effects listed in this document.
Questions with Answers
What are hormones, and how do they work?
Hormones are long-range chemical messengers of the body, manufactured and controlled by the endocrine system. Hence the title of endocrinologist for hormone doctors.
The hypothalamus produces gonadotropin-releasing hormone (GnRH). This signals the anterior pituitary gland to synthesize and release luteinizing hormone (LH). To a lesser degree, GnRH also triggers the synthesis and release of follicle stimulating hormone (FSH). Subsequently, LH and FSH signal the gonads (ovaries in females, testes in males) to synthesize and release hormones that cause differentiation of the body tissue into female or male form: estrogens, progesterones, and testosterones. A small quantity of testosterones are also produced by the adrenal gland. Proportionally, females have more estrogens and progesterones than males. Males have more testosterones.
Estradiols are synthetic estrogen analogues. Estrogens and estradiols excite estrogenic receptors, causing the body to differentiate into female form and function. Natural and synthetic estrogens are hereafter referred to simply as estrogens.
Progestogens (or progestins) are synthetic progesterone analogues. Progesterones and progestogens excite progesteronic receptors, which in cooperation with estrogenic activity, cause the body to further differentiate into female form and function. Natural and synthetic progesterones are hereafter referred to simply as progesterones.
Various testosterones are collectively known as androgens. They excite androgenic receptors, causing the body to differentiate into male form and function. Natural and synthetic testosterones are hereafter referred to simply as androgens.
Anti-hormones can be useful in transsexual hormone therapy because they block hormone action or production. There are several mechanisms:
Androgen receptor antagonist: blocks the action of androgens at certain receptor sites.
Androgen conversion inhibitor: blocks the conversion of one type of androgen to another.
Estrogen receptor antagonist: blocks the action of estrogens at certain receptor sites.
GnRH agonist: Briefly overstimulates then effectively suppresses pituitary LH and FSH production.
Aggressive hormone therapy indirectly reduces natural gonadal hormone production by fooling the pituitary into thinking that there are plenty of hormones already in the body; consequently, the pituitary reduces the LH and FSH signals that stimulate the gonads.
Postnatally administered hormones do not cause development of primary sex organs (uterus, ovaries, vagina, testes, or penis) that are opposite those born with. However, postnatal contrasexual hormone therapy does cause development of secondary sex characteristics as described below.
2. What effect does female hormone therapy have on a male, and how soon?
The longer after puberty hormone therapy is started, the less effective it is--but not a linear scale, e.g., results are considerably more dramatic in an 18 year old than a 28 year old, but results are not on the average dramatically different between a 38 year old and a 48 year old.
The following effects have been observed in varying degrees--anywhere from little to moderate--with extended treatment. With effective and continuous dosages, most of the changes that a particular body is genetically prone to start within 1 to 4 months, start becoming irreversible within 6 to 9 months, start leveling off somewhat within 18 months, and be mostly done within 3 years. The leveling may take longer if the testes are not removed. High levels of estrogen will cause faster development up to a point, but not better results in the long term than moderate levels of estrogen.
Fertility decreases. Sperm count drops rapidly. Sometimes it returns to almost normal if hormonal treatment is discontinued within the first couple of months, but permanent sterility can occur in as little as six months. This should not be counted on for birth control, because a miniscule sperm count might remain until the testes are surgically removed. Estrogens, progesterones, and gonadal androgen production inhibitors are the chemicals responsible for lowering fertility. It appears to the author that the other types of anti-androgens do not necessarily effect fertility--but one would be wise to take frequent fertility tests if one chooses to employ only the other types of anti-androgens with the intent of maintaining fertility.
Male sex drive and enjoyment decreases. Directly stimulated erections become infrequent and difficult to maintain. Spontaneous erections eventually stop. Semen secretion decreases, resulting in less intense or unobtainable ejeculatory orgasms. The testes and prostrate atrophy. The penile skin also shrinks if erections are not regularly encouraged.
Breast size increases. Typical growth is to one to two cup sizes below closely related females (mother, sisters). The growth is not always symmetrical--neither is it for females. Sometimes the areoles and nipples swell, but generally not significantly, unless the body is less than a decade past puberty.
Fat is redistributed. The face becomes more typically female in shape. Fat tends to move away from the waist and toward the hips and buttocks.
Body hair growth (not including head, face, or pubic area) slows, becomes less dense, and may lighten in color.
Many people also report the following effects, but they are not verified in any medical literature that the author has read:
If exercise is not increased, some muscle tone is lost--especially from muscles that were not well-developed before hormone therapy.
Outer skin layer becomes thinner, lending a finer translucent appearance and increased susceptibility to scratching and bruising. Tactile sensation becomes more intense.
Oil and sweat glands become less active, resulting in dryer skin, scalp, and hair.
Scalp hair becomes thicker, and male pattern baldness generally stops advancing. In some cases, a fine fuzz may grow back along the line of where scalp hair was recently lost--but only from the living follicles, not dead ones.
Metabolism decreases. Given a caloric intake and exercise regimen consistent with pre-hormonal treatment, one tends to gain weight, lose energy, need more sleep, and become cold more easily.
Fingernails become thinner and more brittle.
Body odors (skin and urine) change. They become less "tangy" or "metallic" and more "sweet" or "musky".
Internal emotions are amplified, becoming more apparent, distinguishable, and influential. Some people report reduced anxiety and increased sense of well-being. This could be a placebo effect. Changing the hormone therapy (adjusting dosages up or down in the regimen) sometimes causes a week or two of depression and otherwise unexplainable emotional angst.
"Female" sex drive and enjoyment increase. This observation is obviously completely subjective since males have no way to directly compare the experience. Non-ejeculatory orgasms become more likely for those with the predisposition to have them, if for no other reason than the fact that ejeculatory orgasms are difficult or impossible to achieve, and the need for sexual release forces a rewiring of perceptions and responses.
Female hormones do not:
Cause the voice to increase in pitch.
Dramatically reduce facial hair growth in most people. There are some exceptions with people who have the proper genetic predisposition and/or are less than a decade past puberty.
Change the shape or size of bone structure. However, they may decrease the bone density slightly. 3. What effect does male hormone therapy have on a female, and how soon?
The longer after puberty hormone therapy is started, the less effective it is--but not a linear scale, e.g., results are considerably more dramatic in an 18 year old than a 28 year old, but results are not on the average dramatically different between a 38 year old and a 48 year old.
The following effects have been observed in varying degrees--anywhere from little to moderate--with extended treatment. With effective and continuous dosages, most of the changes that a particular body is genetically prone to will start with the very first administration of androgens, start becoming irreversible (only the vocal cord thickening) almost immediately, start leveling off somewhat within 2 years, and be mostly done within 3 years. The leveling may take longer if the ovaries are not removed.
The vocal cords thicken, deepening the voice--although not necessarily all the way down to an average male frequency.
Fertility decreases. Menstrual cycle becomes irregular then stops.
Sex drive increases. Sexual enjoyment may also increase, but the clitoris may become so sensitive as to make direct stimulation painful.
Clitoris elongates, eventually reaching 3-8 cm.
Body and facial hair growth speeds up, becomes much thicker, and may darken.
Male pattern baldness may set in.
Muscle mass increases with exercise. It may even increase slightly with no exercise.
Many people also report the following effects, but they are not verified in any medical literature that the author has read:
Outer skin layer becomes rougher in feeling and appearance.
Oil and sweat glands become more active. This may result in acne.
Fat is redistributed. The face becomes more typically male in shape. Fat tends to move away from the hips and toward the waist.
Metabolism increases. Given a caloric intake and exercise regimen consistent with pre-hormonal treatment, one tends to lose weight, gain energy, need less sleep, become hot more easily, and feel generally more alert. However, appetite usually increases, so one may gain weight because of increased caloric intake and increased muscle mass.
Body odors (skin and urine) change. They become less "sweet" or "musky" and become more "tangly" or "metallic."
Emotions change. Aggressive and dominant feelings may increase.
Male hormones do not:
Significantly decrease the size of the breasts. However, they may soften somewhat.
Change the shape or size of bone structure. However, they may decrease the bone density slightly. 4. How are hormones administered?
ADMINISTRATION OF FEMALE HORMONES
The popular treatment combinations are:
Estrogen alone
Adding an anti-androgen. An anti-androgen fights the androgens remaining in the body. This may enable one to reduce the estrogen dosage and still obtain acceptable development speed, and very similar results in the long run. However, the author is not aware of any one person who has tried the two regimens (high estrogen dosage vs. moderate estrogen dosage plus anti-androgen) for long enough to be able to objectively compare their performance.
Adding a progesterone. Progesterone administered with estrogen promotes extra breast growth by increasing the volume of the lactation and ducting tissue. Some studies of birth control pills in females seem to show that progesterones administered with estrogens reduce the risk of cancer from administration of estrogens alone.
Adding another type of estrogen. This may cause faster results for some people, but not necessarily better results in the long run.
Some endocrinologists mimic a female cycle by decreasing or eliminating estrogen for one week of the month and/or adding or increasing progesterone for the same week. The author is not aware of solid evidence that this is either beneficial or harmful, although a recent study in females seemed to show that cycling progesterones may decrease the beneficial effect of estrogen on cardiovascular health. The primary effect of cycling is the invocation of extreme mood swings similar to PMS in females.
ADMINISTRATION OF MALE HORMONES
The popular treatment combinations are:
Single androgen
HORMONES ARE DELIVERED BY THE FOLLOWING METHODS:
Oral (estrogens, progesterones, androgens): This is the popular delivery method for estrogens and progesterones. The main advantage is convenience. The main disadvantage is increased stress on the liver since it has to process the hormones twice instead of just once.
Injection (estrogens, progesterones, androgens): This is the popular delivery method for androgens. The main disadvantages are unsteady hormone levels (except for sustained-release preparations in oil or microscopic beads), and pain and infection risk from hypodermic needle usage.
Dermal patch (estrogens, androgens): The main disadvantage is skin irritation. Androgen patches are meant to be applied to a post-surgical genital site.
Cream (estrogens): The main disadvantage is the low transfer rate into the body, too low to be effective unless it is very frequently rubbed on very large skin surfaces. Application to just the breast area does not limit the distribution to that area; the little estrogen absorbed is distributed throughout the body and in insufficient quantity to make the breasts grow significantly. The only obvious effect is moister and healthier skin.
RESULTS
A hormone therapy regimen that works well for one person may not for another. If development is not well under way in, say, 4 months, some experimentation may be in order; try different hormone types and/or combinations.
Hormone dosage can usually be reduced to a nominal maintenance level after the testes or ovaries are surgically removed.
5. How can the intended effects of hormone therapy be maximized and the dangers minimized?
IN GENERAL:
Before starting hormone therapy, take a physical exam and the following blood tests:
+ Minimum: liver, thyroid, kidney and lipid (cholesterol)
profiles; serum prolactin and sugar levels; blood clotting
time.
+ Interesting: calcium and phosphorus (skeletal health); serum
androgen levels. The androgen test is rather expensive, and
not necessary if one is using clinical results (visible body
changes and, for male-to-female transsexuals, cessation of
spontaneous erections) for feedback of therapy
effectiveness. Particularly in female-to-male transsexuals,
androgen therapy creates such dramatic clinical results that
there is usually little reason to pay for the test except to
satisfy curiousity, or if the clinical results are
unsatisfactory.
* Be constantly aware of the body so that adjustments can be made
if any new problems develop during therapy.
* Have regular medical checkups (every 2-3 months); pay close
attention to vital signs.
* Eat well, and take a good multi-vitamin/mineral supplement to
help be sure the body has everything it needs for new
development.
* Do not start taking the maximum planned dosage of all hormones at
once. Start with a low dose of one, and carefully watch for
negative vital signs and symptoms. If there are no problems after
one month, increase the dosage to the planned level. Wait another
month before adding the next hormone or anti-hormone. Do not
change the regimen radically or more often than once per month.
Give the body time to adjust.
* Use the lowest hormone dosage that affords the desired changes.
Not everyone needs the same dosage, because of differences in
body weight and genetically-disposed sensitivity to the hormones.
Hormone dosage can usually be reduced to a nominal maintenance
level after the testes or ovaries are surgically removed. It is
not recommended to take pre-operative dosages of hormones for
more than about 3 years.
* Have bone density checked once every few years.
* Try the daily dosage of a hormone before moving to a
sustained-release version, e.g., make sure you are not allergic
to Provera tablets before you use Depo-Provera (the sustained
release intramuscular injection).
MALE TO FEMALE
Use the lowest hormone dosage that affords the desired changes. Even without an expensive blood serum androgen level test, one can tell when their androgen level is being pushed to the minimum possible level by noting that spontaneous erections become very infrequent or cease entirely, and that body development is as expected.
Estrogens delivered orally strain the liver more than other delivery methods. However, it is not highly dangerous unless the liver is already weakened by alcohol, drug use, or infection. It is a good idea to reduce alcohol and other drug intake. Monitor liver stress with a liver profile blood test every 6-12 months.
Susceptibility to hardening of the arteries decreases somewhat, but susceptibility to blood clots, phlebitis (inflammation of lower extremity and pelvic veins), varicose veins, elevated high blood pressure increases somewhat. Stop smoking, reduce stress, and increase aerobic exercise. Investigate severe leg pain by x-ray or ultrasound to determine if it is caused by a blood clot before massaging it. Leg and foot cramping not caused by a blood clot might be reduced with potassium and vitamin E supplements (but one should not take potassium concurrently with spironolactone). Monitor blood clotting time with a test every 6-12 months. Stop or drastically reduce estrogen dosage at least one month before having major surgery. Take about 80mg/day aspirin to reduce the risk of blood clots; take it with food and liquid to reduce the risk of stomach ulcer--or, better yet, use the enteric safety-coated variety.
Significant discharge from the nipples (more than would cause about a 2cm diameter stain on the bra) may be a sign of a dangerously elevated prolactin level due to intolerance of the estrogen dosage. Immediately take a test to measure the serum prolactin level; otherwise, take the test every 6-12 months anyway. Note that there may be a dramatic spike in the prolactin level, causing significant lactation for up to a week, if a high estrogen dosage is suddenly stopped; this is similar to the process in a female who has just bore her child.
Since spironolactone (Aldactone) is a diuretic, anyone taking it should drink plenty of water, especially before and after exercise, and may need to reduce dietary intake of potassium--especially if the kidneys are already stressed. Take a blood electrolyte balance test every 6-12 months.
Breast cancer risk seem to be low in comparison to females receiving estrogen replacement therapy. Certain studies in females seem to show that the cancer risk is lowered by consistently administering progesterone with the estrogen. Perform regular breast self-exams, anyway; take mammograms every 2 years before age 35, every year thereafter. Prostate cancer risk is significantly reduced in comparison to males not receiving estrogen therapy. Have the prostate examined once a year if possible, anyway.
FEMALE TO MALE
There is an increased risk of arterial hardening (particularly in the heart) due to increased serum cholesterol levels. Change the diet to reduce cholesterol.
Androgens can stimulate various kinds of liver tumors and cysts, especially if the liver is already weakened by alcohol, drug use, or infection. Reduce alcohol and other drug intake. Monitor liver stress with a liver profile blood test every 6 months.
If the menstrual cycle has not ceased within about 5 months of a steady androgen regimen, take a blood test to check the serum androgen level.
Some recent studies seem to show that tobacco or marijuana smoking reduces the efficiency of androgen uptake.
Even if most of the breast tissue is removed by a masectomy, there is enough tissue left to place female-to-male transsexuals at approximately the same risk for breast cancer as genetic males. Perform regular breast self-exams; have any unusual lumps checked immediately. 6. How can one obtain hormones?
In the U.S., most reputable therapists and medical doctors who regularly work with transsexuals follow the Harry Benjamin Standards of Care, a plan that specifies that one must undergo a minimum of 3 months of psychotherapy to obtain a letter of recommendation to an endocrinologist. One can choose to work with doctors who do not follow the Benjamin Standards, but, in any case, it is a very good idea to meditate and cogitate on the implications for at least 3 months before starting hormone therapy. Some transsexuals find the Benjamin Standards too constrictive--even insulting; others find it worth the trouble to go through the hoop in order to be referred to an endocrinologist who is particularly knowledgeable in the treatment of transsexuals. Choose carefully.
Male-to-female transsexuals: if a sympathetic endocrinologist is not available, try local gynecologists; they are sometimes more understanding, and are used to prescribing estrogens and progesterones.
One should only take hormones that were obtained directly from a licensed pharmaceutical distributor; the quality of drugs obtained through other channels is not only suspect, but likely dangerous-- especially those in injectable form.
Some people are able to get their health insurance company to cover hormones just like any other prescription drug, especially if the doctor prescribes them for a "hormone imbalance" rather than "transsexual hormone therapy." When a health insurance company subcontracts out prescription drug coverage to another company, benefits for hormones are not generally questioned since there is little communication between the two companies.
7. Are birth-control pills a good source of estrogen?
No. Although early birth-control pills contained significant quantities of estrogen, modern ones do not. A typical birth-control pill now contains a tiny dose of progesterone, with or without a tiny dose of estrogen--less than one-tenth the strength required for an effective course of treatment for a male-to-female transsexual. If one is absolutely determined to use a particular birth-control pill, then one should carefully study the PDR to understand the doses of the component hormones of the pill in question, compared to the typical dosages of the same hormones in this FAQ.
8. How can lactation be induced?
This section is provided for curiosity only; the author has no medical references--only anecdotes from other transsexuals and mothers, popular media, and some experience with bovines--to substantiate the answer.
One must maintain a high level of estrogen for quite a while--probably a minimum of 6 months--then suddenly drop it. That is apparently enough in some males to kick the pituitary into releasing enough prolactin (milk-producing hormone) to make it possible to start some lactation.
Along with estrogen, progesterone plays a significant role in the development of lactating tissue (glands and ducts), so maintaining a moderate to high level of progesterone for probably at least 6 months previous would also help.
Finally, assuming the lactating tissue is developed and the milk comes in, one would need to frequently stimulate the milk "let-down" secretion reflex with oxytocin, by either artificially administrating it, or naturally generating it with practice with similar enviromental stimuli that nursing females use (relaxing, hearing or thinking of the baby being hungry, direct sucking stimulation of the nipples and immediately surrounding tissue, orgasm, etc.).
Not a lot of milk is produced unless suckling (or expressing) is frequent and consistent, say every 2-3 hours. Less stimulation than that, say, once every 5-8 hours, will result in dramatically less milk production. Less than that will result in complete cessation of milk production within 1-3 weeks after it starts.
In summary, one has to be committed to the notion of actively and consistently nursing and/or expressing; it is quite a project.
If the milk is to be used for feeding a baby, one should consult the PDR for warnings about usage of hormones and other drugs while nursing.
For more information, try contacting your local chapter of the La Leche Society. They specialize in issues of breast-feeding.
9. How can a male be neutered without causing feminization?
One can cause the gonads to dramatically reduce androgen production by shutting down the output of LH and FSH from the pituitary gland. This can be done one of two ways:
Introducing consistently large quantities of any estrogen or progesterone. Progesterone does not have a feminizing effect, so one could use medroxyprogesterone acetate (Provera). This has been demonstrated to work on males with severe behavioral disorders exacerbated by androgens (read: serial rapists), who were given the choice of taking periodic Depo-Provera shots or remaining in prison. The sustained-release injectable preparation is easier on the liver than orally delivered tablets, but one should first try the tablets for a month or two to be sure there is not an allergic reaction. Be aware that there are annoying and dangerous adverse effects with progesterones, ranging from severe mood swings to blood clotting disorders.
Alternatively, one can use a GnRH agonist. This is a more elegant solution, and has fewer adverse affects than progesterones. However, it might be more difficult to get a doctor to prescribe one.
Note that neither of these methods can be used for reliable birth control; some small amount of sperm may still be produced, even if the androgen levels are forced to be very low.
Stopping the administration of progesterone or GnRH agonist will result in the gonads resuming androgen (and sperm) production within a few months. The degree to which production is restored depends on how long the progesterone or GnRH agonist was used; the author's guess is that treatment of more than a few months will result in some degree of atrophy of the gonads; more than six months may result in permanent sterility. There has been little research on the reversibility of this treatment.
10. Exactly what hormones are available? What are the details on popularity, dosage, availability, price, contraindications, adverse effects, etc.?
ESTROGENS
The following estrogens are popular for treatment of male-to-female transsexuals, and are presented in descending order of preference in the humble opinion of the author:
Estinyl, Estigyn, Etivex (ethinyl estradiol)
Estrad Val (estradiol valerate, 17 beta estradiol)
Estraderm (17 beta estradiol)
Estrace (17 beta estradiol)
Premarin (conjugated natural estrogens)
Menest
The following estrogens have been suggested for treatment of male-to-female transsexuals, but the author does not have information about how effective they are. Since their primary indication is for replacement therapy in females, they are probably suitable and relatively safe. They are presented in alphabetical order:
Estratab
Estrovis (quinestrol)
Ogen (estropipate)
Ortho-Est (estropipate)
The following estrogens have been suggested for treatment of treatment of male-to-female transsexuals, but the author does not have information about how suitable, effective, or safe they are. They are presented in alphabetical order:
Delestrogen
Estradurin (polyestradiol phosphate)
Estrone
Menrium
TACE (clorotrianazine)
The following estrogens have been suggested for the treatment of transsexuals, but, in opinion of the author, the adverse effects strongly outweigh the potential benefits. They are included here for the sake of warning, and are presented in alphabetical order:
Diethylstilbestrol, DES
The following natural sources of phytoestrogens (estrogen-like compounds) have been identified, but the author is not aware of an effective course of treatment using them. They work by weakly binding to estrogen receptors. In males, this may result in a mild feminizing effect (in females, it may give the opposite result, that is, a mild androgenic effect, since the phytoestrogens are competing with endogenous true estrogens for the estrogen receptors). Since phytoestrogens are not nearly as efficacious as true estrogens, huge and potentially toxic amounts of these items would have to be consumed. They are presented in alphabetical order:
Black Cohosh (Cimicifuga racemosa)
Blue Cohosh
Borrage
Butterfly Weed
Caraway
Chaste Tree or Vitex (Verbenaceae species)
Dates
Dill
Dong Quai (Angelica sinensis)
False Unicorn root
Fennel seed
Fenugreek
Ginseng
Goats Rue
Gotu Kola
Licorice root
Linseed or Flaxseed
Milk thistle
Motherwort
Pennyroyal (Hedeoma pulegioides)
Pleurisy root
Pomegranates
Red Clover Sprouts
Red Raspberry leaf
Southernwood
Soya Flour
Tansy
Preparations advertized to contain "raw ovaries" from any animal have not been proven to be effective.
PROGESTERONES
The following progesterones are popular for treatment of male-to-female transsexuals. They are presented in alphabetical in order.
Amen, Cycrin, Provera (medroxyprogesterone acetate)
Depo-Provera (medroxyprogesterone acetate)
The following progesterones have been suggested for treatment of treatment of male-to-female transsexuals, but the author does not have information about how suitable, effective, or safe they are. They are presented in alphabetical order:
Aygestin (norethindrone acetate)
Norlutate (norethindrone acetate)
Norlutin
The following natural sources of phytoprogesterones (progesterone-like compounds) have been identified, but the author is not aware of an effective course of treatment using them. Since phytoprogesterones are not nearly as efficacious as true progesterones, huge and potentially toxic amounts of these items would have to be consumed. They are presented in alphabetical order:
Suma
Vitex
Wild Yam
ANDROGENS
The following androgens are popular for treatment of female-to-male transsexuals, and are presented in descending order of preference in the humble opinion of the author:
Depo-testosterone (testosterone cypionate)
Android, Testred (methyl testosterone)
Halotestin (fluoxymestrone)
Metandren (methyl testosterone)
The following androgens have been suggested for treatment of treatment of female-to-male transsexuals, but the author does not have information about how suitable, effective, or safe they are. They are presented in alphabetical order:
Anabolex
Anadrol (oxymetholone)
Anavar
Deca Durabolin (nandrolone decanoate)
Delatestryl (testosterone enanthate)
Dianabol
Droblan
Durabolin (nandrolone phenpropionate)
Maxibolin
Mesterolone
Methandriol
Neo-Hambreol (andgrogen)
Nilevar
Winstrol (stanozolol)
The following natural sources of phytoandrogens (androgen-like compounds) have been identified, but the author is not aware of an effective course of treatment using them. Since phytoandrogens are not nearly as efficacious as true androgens, huge and potentially toxic amounts of these items would have to be consumed. They are presented in alphabetical order:
Diosterol
Gamma Oryzanol
Mesobolin
Sarsparilla (Smilax Officinalis)
ANTI-ANDROGENS
The following anti-androgens are popular for treatment of pre-operative male-to-female transsexuals. They are presented in descending order of preference in the humble opinion of the author:
Androcur, Cyprostat, Cyproteron (cyproterone acetate)
Aldactone (spironolactone)
The following anti-androgens have been suggested for treatment of treatment of pre-operative male-to-female transsexuals, but the author does not have information about how suitable, effective, or safe they are. They are presented in alphabetical order:
Anandron (RU 23.903)
Cytadren (aminoglutethimide)
D-tryptophan
Eulexin, Euflex (flutamide)
Megase (megestrol)
Nizoral (ketoconazole, imidazone peperazine)
Proscar (finasteride)
?? (nilutamide)
The following natural sources of phytoantiandrogens (anti-androgen-like compounds) have been identified, but the author is not aware of an effective course of treatment using them. Since phytoantiandrogens are not nearly as efficacious as true antiandrogens, huge and potentially toxic amounts of these items would have to be consumed. They are presented in alphabetical order:
Saw Palmetto
ANTI-ESTROGENS
The following anti-estrogens have been suggested for treatment of treatment of pre-operative female-to-male transsexuals, but the author does not have information about how suitable, effective, or safe they are. They are presented in alphabetical order:
Cyclofenil
Danocrine
Nolvadex (tamoxifen citrate)
Teslac (hydroxylactone, testolactone)
OTHER ANTI-HORMONES (GNRH AGONISTS)
These pharmaceuticals can be used to dramatically reduce gonadal hormone production in both males and females. This type of chemical castration might be worth investigating for those cases when the pre-operative TS cannot take the hormones of choice because of other health problems (e.g., hormone dependent tumors or blood clotting disorders), and cannot yet have the surgery performed. They are presented in alphabetical order. Lupron seems to cause more adverse reactions than the others.
Lupron (leuprolide acetate)
Supprelin (histrelin acetate)
Synarel (nafarelin acetate)
Zoladex (goserelin acetate) 11. Where is there more information about hormones?
Books
Databases
Articles
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FAQ - Frequently Asked Questions
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Below find a list of common Breast Augmentation FAQ - Frequently Asked Questions and Silicone Breast Implants FAQ - Frequently Asked Questions.
If you have a question you would like answered by a Board Certified Plastic Surgeon, click here to Ask an Expert!
Although Breast Augmentation is a common procedure, it is extremely important for you to consult with a Board Certified Plastic Surgeon for specific advice relating to you. Breast Implants USA serves only as an informational tool in researching Breast Augmentation.
Numerous Board Certified Plastic Surgeons can be found in your area by clicking here.
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Breast Augmentation FAQ - Frequently Asked Questions
Either click on the question to jump to the answer, or you may scroll through the entire list of questions.
1. How common of a procedure is Breast Augmentation?
2. Why choose a plastic surgeon who is Board Certified versus one who is not?
3. How is the Breast Augmentation Surgery performed?
4. What should I expect during my initial consultation?
5. What is a common mistake made when choosing a plastic surgeon?
6. How much does it cost for a Breast Augmentation?
7. What is the best way to pay for a Breast Augmentation?
8. How long do I have to stay in the hospital?
9. How long does a breast augmentation take?
10. How long does it take to fully recover from a Breast Augmentation?
11. Does Breast Implants USA have any suggestions for questions I should ask a prospective surgeon?
Silicone Breast Implants FAQ - Frequently Asked Questions
Source: FDA
Either click on the question to jump to the answer, or you may scroll through the entire list of questions.
1. What Are Breast Implants?
2. What types of breast implants are approved by the FDA?
3. How are the breast implants used?
4. Are there any age limits with respect to who can get breast implants?
5. Why is the age minimum different for augmentation for saline-filled and silicone gel-filled breast implants?
6. Are clinical studies of breast implants still being conducted?
7. What are the risks of breast implants?
8. How long do breast implants last?
9. What causes breast implants to rupture?
10. How will I know if my breast implant has ruptured?
11. What are some of the important factors I should consider when deciding whether or not to get breast implants?
12. What are "gummy bear" gel breast implants?
13. What guidance does FDA provide to the companies that make breast implants?
14. What was the basis for FDA’s decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
15. Who can get Mentor and Allergan silicone gel-filled breast implants?
16. What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel-filled breast implants?
17. What did the Core Studies show regarding the rate of rupture and the consequences of rupture?
18. What conditions of approval did FDA place on these implants?
19. If silicone gel-filled breast implants are safe, why is FDA requiring such large post-approval studies?
20. What if the post-approval studies uncover unexpected problems?
21. How will FDA ensure that Allergan and Mentor complete their post-approval studies?
Still have questions? Check out this Breast Augmentation article from our Articles page.
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1. How common of a procedure is Breast Augmentation?
According to the American Society of Plastic Surgeons, the number of Breast Augmentation surgeries has increased by 24% since the beginning of January 2000. In 2004, there were a total of 264,041 procedures done.
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2. Why choose a plastic surgeon who is Board Certified versus one who is not?
In order for a plastic surgeon to become board certified, they have to go through a long, demanding process. It is not something that can be purchased. It is not a 6-month long process; it is a process that takes years. That is why there are so many more plastic surgeons that are not board certified. Plastic Surgeon’s willing to invest that amount of time, studying and studying more, and on top of that passing the tests, and then following the comprehensive rules set forward, in our opinion, deserve the respect that brings.
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3. How is the Breast Augmentation surgery performed?
The plastic surgeon makes an incision (Note, the incision can be made in different locations of your body, depending on your preference), raising the tissue, and placing a breast implant underneath. The breast implant can be placed in one of two places. It can be placed either directly under your breasts or it can be placed under the chest muscle. The placement of the breast implants are dependent on your particular breasts, discomfort after surgery, level of activity (sports particularly) and other considerations that you should discuss with your Board Certified Plastic Surgeon on your initial consultation.
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4. What should I expect during my initial consultation?
Breast Augmentation is a very personal decision and the initial consultation is the most effective way for you to know if it is right for you. It is helpful for you to bring in a list of questions and concerns that can be specifically addressed. You and your breast surgeon will discuss your goals and how realistic they are. It is a very good idea to bring in before and after photos of other women with your desired results. This can give your breast surgeon a very good idea of the results you are looking for. This is also the time to discuss your preferred incision type, the type of breast implants used and both your short term and long term goals. If you are not 100% confident in the breast surgeon you should consult with another. It is probably one of the most personal decisions you will make, so you not only need to be confident it is the right thing for you, but also be confident that the breast surgeon can meet your goals.
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5. A common mistake in choosing a plastic surgeon….
It is important to note that prices are different at every single breast surgeon’s location. Our recommendation is to not make a decision in choosing a breast surgeon based on price. You decision should be based solely on if that breast surgeon can meet your specific needs. However, keep your eyes open as well. It is common to find that 10 plastic surgeons are within 5% of each other’s price, and there is that one plastic surgeon who charges half of everyone else’s price. Be cautious, as that is usually a quick red flag. In no way does that mean paying less will give you worse results, it only means that your decision should never solely be based on price.
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6. How much does it cost for a Breast Augmentation?
This is a simple question with a difficult answer. It completely depends. It depends on the doctor’s location, the type of breast implant used, the difficulty of the specific case and the type of incision. Overall, it is fair to say that Breast Augmentation surgeries range anywhere from $3,500 to $12,000. These costs include anesthesia, operating room facility, hospital stay if necessary and other miscellaneous expenses. In most cases, insurance usually will not cover the costs. However, do not worry.
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7. What is the best way to pay?
Quite frankly, cash or credit card. However, nothing can be that simple. Breast Implants USA offers patient financing. We understand everyone has unique situations, so there are programs that have 0% APR for the first 12 months, to low rates for up to four years.
If you are interested in applying for breast augmentation financing, click here.
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8. How long do I have to stay in the hospital?
Typically you will be at home, in the comfort of your own bed within a few hours of the surgery being performed. There is typically no need to stay the night in a hospital.
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9. How long does a Breast Augmentation take?
Breast augmentation surgery typically takes anywhere from one hour to three hours. The amount of time completely depends on the type of incision being made, the type of anesthesia used and other circumstances.
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10. How long does it take to fully recover from a Breast Augmentation?
We hate to be vague but this is one thing that should only be discussed with your breast surgeon. Nobody knows your specific situation and only your breast surgeon should be given the right to explain exactly what you should expect, because only the breast surgeon (and yourself) know your specific situation. When it comes to recovery, only take the advice of your expert breast surgeon.
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11. I want to be sure to ask the right questions and know I will forget if I do not write them down. Do you have any?
We do have a list of common questions you can ask your plastic surgeon.
Click here for a printable version so you can take it in with you to your consultation (PDF).
A. How long has the surgeon been doing breast augmentation?
B. Has the plastic surgeon ever had his/her medical malpractice insurance denied or revoked?
C. How many breast augmentation has the doctor done in total?
D. Is there a warranty on the implants?
E. How long will the procedure take?
F. What are the risks of having a breast augmentation? Both short term and long term?
G. What type of anesthesia will be used and who will administer it?
H. Where will the procedure be performed?
I. Does the plastic surgeon have any before and after photos to view?
J. How long will it take to recover fully?
K. What can I expect in the recovery process?
L. Is there anything I can do to make the recovery process quicker?
M. Are my goals realistic?
N. Am I a good candidate for a Breast Augmentation?
O. Are there any questions most patients asked that I have not asked?
P. How soon can I have the surgery?
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Silicone Breast Implants FAQ - Frequently Asked Questions
1. What are breast implants?
Breast implants are medical devices that are implanted either under breast tissue or under the chest muscle for breast augmentation or reconstruction. There are two major types: saline-filled and silicone gel-filled. Saline-filled breast implants are silicone shells that are either prefilled or filled with saline during surgery, and some of these allow for adjustments of the filler volume after surgery. Silicone gel-filled breast implants are silicone shells prefilled with silicone gel. Breast implants vary in profile, size, and shell surface (smooth or textured).
Source: FDA
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2. What types of breast implants are approved by FDA?
FDA has approved four breast implants for marketing in the U.S.:
In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.
In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.
All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive ("gummy bear") implants. For a woman to receive an investigational breast implant in the U.S., she must enroll in a clinical study.
Source: FDA
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3. How are breast implants used?
Breast implants are used for:
primary augmentation (to increase breast size for cosmetic reasons)
revision-augmentation ( revision surgery to correct or improve the result of an original breast augmentation surgery)
primary reconstruction (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)
revision-reconstruction ( revision surgery to correct or improve the result of an original breast reconstruction surgery).
Source: FDA
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4. Are there any age limits with respect to who can get breast implants?
Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 18 years or older.
Mentor and Allergan silicone gel-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 22 years or older.
FDA restricts the marketing of breast implants for augmentation to women of a minium age because young women's breasts continue to develop through their late teens and early 20s and because there is a concern that young women may not be mature enough to make an informed decision about the potential risks. However, there is there is no age restriction on the marketing of these products for reconstruction, so as to allow young women to have access to breast implants 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.
Source: FDA
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5. Why is the age minimum different for augmentation for saline-filled and silicone gel-filled breast implants?
FDA approved saline-filled breast implants for augmentation in women ages 18 and older. FDA approved silicone gel-filled implants for women ages 22 and older. The age restrictions are different because the risks are different for the two products. For example, silicone gel-filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that can go undetected by you or your doctor). There is no risk of silent rupture for saline-filled implants. In addition, the health consequences of a ruptured saline-filled breast implant are different from those of a ruptured silicone gel-filled breast implant.
Source: FDA
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6. Are clinical studies of breast implants still being conducted?
There are several ongoing clinical studies (i.e., investigational device exemption (IDE) applications) of saline and silicone gel-filled breast implants. These studies include those for the more cohesive silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed), as well as studies conducted by other manufacturers. These devices are still in research and have not been approved for marketing.
In addition, Mentor and Allergan will are conduct studies on patients who get silicone gel-filled breast implants after they are approved.
Source: FDA
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7. What are the risks of breast implants?
Some of the risks of breast implants include:
reoperations (additional surgeries), with or without removal of the device
capsular contracture (hardening of the area around the implant)
breast pain
changes in nipple and breast sensation
rupture with deflation for saline-filled implants
rupture with or without symptoms for silicone gel-filled implants
migration of silicone gel for silicone gel-filled breast implants.
Source: FDA
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8. How long do breast implants last?
Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to rupture, other complications (for example, capsular contracture, breast pain), or unacceptable cosmetic outcomes (for example, asymmetry, unsatisfactory style/size, wrinkling/rippling).
Source: FDA
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9. What causes breast implants to rupture?
We do not know all of the causes of breast implant rupture. We do know that breast implants can rupture from:
damage during implantation or during other surgical procedures
folding or wrinkling of the implant shell
trauma or other excessive force to the chest
compression of the breast during mammography.
Source: FDA
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10. How will I know if my breast implant has ruptured?
If your saline-filled breast implant ruptures, you or your doctor will be able to tell. When saline-filled breast implants rupture, they deflate and the saline solution leaks into your body immediately or over a period of days. You will notice that your implant loses its original size or shape.
If your silicone gel-filled breast implant ruptures, it is likely that neither you nor your doctor will know. This is known as a silent rupture. This is why MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture. However, sometimes there are symptoms. These symptoms include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.
Source: FDA
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11. What are some of the important factors I should consider when deciding whether or not to get breast implants?
Some important factors to consider include:
Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to complications or unsatisfactory cosmetic outcomes.
Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implants removed and not replaced, your breasts will not change back to the way they looked before your implant surgery. You may have permanent dimpling, puckering, wrinkling, or other cosmetic changes.
When you have your implants replaced (revision), your risk of complications increases compared to your first (primary) surgery.
Routine mammograms to screen for breast cancer will be more difficult with breast implants.
Breast implants may affect your ability to breast feed, either by reducing or eliminating milk production.
Factors to consider specifically about silicone gel-filled breast implants include:
If your silicone gel-filled breast implant ruptures, you may have no symptoms. This is called a silent rupture because, most of the time, neither you nor your doctor will know that your implant has ruptured.
The best way to determine whether or not your silicone gel-filled implant has ruptured is with an MRI examination. You should have your first MRI three years after your implant surgery and every two years thereafter.
Over your lifetime, the cost of MRI screening may exceed the cost of your initial surgery. This cost may not be covered by medical insurance.
Source: FDA
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12. What are "gummy bear" gel breast implants?
The so-called "gummy bear" implants are more cohesive silicone gel-filled breast implants made of a firmer silicone gel filler to help maintain the shape of the implant. At this time, these breast implants are available only through clinical studies being conducted by Mentor and Allergan (formerly Inamed).
Source: FDA
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13. What guidance does FDA provide to the companies that make breast implants?
FDA publishes guidance documents that describe FDA's current thinking on a topic and contain recommendations for companies . Although guidance documents are often helpful to companies, they do not create legal requirements, and their recommendations do not bind or require a company to take any specific steps. Many guidance documents advise companies how to test their products. Other guidance documents describe how companies should prepare their applications and how FDA monitors products once they are on the market.
FDA issued a guidance document on breast implants called "Saline, Silicone Gel, and Alternative Breast Implants." It describes the types of information that breast implant companies should submit to FDA when seeking approval of a breast implant so that we can assess whether or not there is a reasonable assurance that the device is safe and effective. The latest version of the breast implant guidance document was published in November 2006 and reflects information learned from two Advisory Panel meetings, over 50 comments on the 2004 draft version of the guidance document, and FDA's review of two silicone gel-filled breast implant premarket approval applications (PMAs).
Source: FDA
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14. What was the basis for FDA's decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
Scientific information in the PMAs demonstrated that there is a reasonable assurance that Allergan (formerly Inamed) and Mentor's silicone gel-filled breast implants are safe and effective and that there is adequate information about these products to enable women to make informed decisions about whether to get them.
FDA's decision was based on:
a thorough review of the companies' Core Studies, including three years of data for Mentor and fours years of data for Allergan
a thorough review of the companies' other clinical information, such as data from the Adjunct Studies (open access studies for reconstruction and revision patients), and international studies
a thorough review of the companies' laboratory testing data
a thorough review of the published scientific literature on silicone gel-filled breast implants
inspections of the manufacturing facilities of both companies to ensure that the implants will be manufactured according to the Quality System Regulations (http://www.fda.gov/cdrh/humfac/frqsr.html)
deliberations of the October 2003 and April 2005 Advisory Panels
the laws regulating medical devices.
Source: FDA
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15. Who can get Mentor and Allergan silicone gel-filled breast implants?
The Mentor and Allergan (formerly Inamed) implants were approved for:
Breast reconstruction in women of any age. Breast reconstruction includes:
primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly; and
revision-reconstruction to correct or improve the result of breast reconstruction surgery.
Breast augmentation in women 22 years or older. Breast augmentation includes:
primary augmentation to increase the breast size; and
revision-augmentation to correct or improve the result of breast augmentation surgery.
Source: FDA
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16. What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel-filled breast implants?
In the Mentor and Allergan (formerly Inamed) Core Studies, the most frequent complication was reoperation (additional surgery). Capsular contracture was another frequent complication. Other frequent complications included implant removal, breast pain, nipple sensation changes, and asymmetry.
For both Core Studies, some women experienced more than one complication. In addition, the complication rates were typically higher for revision (reoperation) implants than for primary (first time) implants.
Source: FDA
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17. What did the Core Studies show regarding the rate of rupture and the consequences of rupture?
Rupture rate and consequences of rupture were characterized for each Core Study. Consequences of rupture include intracapsular rupture (when the gel remains within the scar tissue capsule surrounding the implant), extracapsular gel (when the gel moves outside the capsule but remains within the breast tissue), migrated gel (when the gel moves beyond the breast), and clinical consequences.
Rupture rate was assessed for patients who had scheduled MRIs to screen for non-symptomatic, or silent, rupture (the MRI cohort), as well as for those who did not have scheduled MRIs to screen for silent rupture (the non-MRI cohort).
For the Mentor Core Study, all reported ruptures were from patients in the MRI cohort. The rupture rates were 0.5% for primary augmentation, 7.7% for revision-augmentation, 0.9% for primary reconstruction, and 0% for revision-reconstruction through 3 years. There were 8 ruptured/suspected ruptured implants in 6 patients through 3 years. Two of the implants were explanted and confirmed to be ruptured; the remaining 6 were considered suspected ruptures based on MRI evaluation. Of the 8 ruptured/suspected ruptured implants, 4 showed intracapsular gel and 4 showed extracapsular gel. There were no cases of migrated gel.
For the Allergan (formerly Inamed) Core Study, the reported ruptures were from patients in both the MRI and non-MRI cohorts. The rupture rates in the MRI cohort were 2.7% for primary augmentation, 4.0% for revision-augmentation, 0% for primary reconstruction, and 0% for revision-reconstruction through 4 years. For the non-MRI cohort, rupture was reported in 1 primary augmentation, 1 revision-augmentation, 0 primary reconstruction, and 1 revision-reconstruction patient. Across all patients in the study, t here were 9 ruptured/suspected ruptured implants in 9 patients through 4 years. Five of the implants were explanted and confirmed to have ruptured; the remaining 4 were considered suspected ruptures based on physical or MRI evaluation. All 9 ruptured/suspected ruptured implants showed intracapsular gel, and one intracapsular gel progressed into an extracapsular gel following exploratory surgery to confirm the rupture. There were no cases of migrated gel.
It is important to note that FDA performed an extensive review of all available data, both clinical and preclinical, to characterize rupture rate and consequences of rupture (i.e., intracapsular rupture, extracapsular gel, migrated gel, and health consequences of rupture). The Core Study was not the only source of information used to characterize rupture.
Source: FDA
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18. What conditions of approval did FDA place on these implants?
FDA is requiring each company to do the following:
Continue its Core Study until all patients have completed their 10-year evaluation in order to assess the long-term clinical performance of its product. This involves:
collecting data via annual physician follow-up evaluations
giving all patients MRIs every other year
evaluating all patients whose breast implants were removed without replacement through 10 years.
Conduct a separate 10-year large post-approval study that will:
involve a large number of silicone gel-filled breast implant patients (approximately 40,000)
involve a control group of saline-filled breast implant patients
provide information about certain endpoints: local complications; rates of connective tissue disease and its signs and symptoms; rates of neurological disease and its signs and symptoms; potential effects on offspring of women with breast implants; potential effects on reproduction and lactation; rates of cancer; rates of suicide; potential interference of breast implants with mammography; and patient compliance with MRI recommendation and rupture rates
survey patients annually using web, mail, or telephone questionnaires
have physician evaluations at years 1, 4-6, and 9-10 for Mentor and years 1, 4, and 10 for Allergan (formerly Inamed) to collect local complication data.
Continue its laboratory studies to continue to further characterize the modes and causes of failure of explanted (removed) devices over a 10-year period.
Have an independent group conduct a focus group study of the format and content of the approved patient labeling.
Distribute approved patient labeling to women considering silicone gel-filled breast implants as part of a formal informed decision process, and monitor the process to ensure that patients are being informed of the risks and benefits.
Stop new patient enrollment into the Adjunct Studies and continue to follow all currently-enrolled patients through the final 5-year study timepoint.
require participation in the company's physician training program for physician access to the product
Comply with FDA's requirements for tracking these devices from their manufacture through the distribution chain to implantation. The purpose of mandatory device tracking is to ensure that companies can promptly locate devices in commercial distribution as well as those that have been implanted. Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.
FDA intends to present an update on the status of the conditions of approval at public Advisory Panel meetings in five and 10 years, and at any other FDA decides is appropriate.
Source: FDA
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19. If silicone gel-filled breast implants are safe, why is FDA requiring such large post-approval studies?
FDA determined that there were adequate data to support the approval of the Mentor and Allergan (formerly Inamed) products. Now that the products have been determined by FDA to be safe and effective, we will continue to monitor their safety and effectiveness by requiring each company to conduct a study of approximately 40,000 women through 10 years. The large post-approval studies will gather data on long-term local complications, connective tissue disease and its signs and symptoms, neurological disease and its signs and symptoms, reproductive issues, offspring issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and rupture results. FDA anticipates that data from these long-term studies will provide important information for patients and physicians and may lead to improvements in device labeling.
Source: FDA
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20. What if the post-approval studies uncover unexpected problems?
If the post-approval studies uncover any new risks or unexpected problems, FDA can pursue a range of regulatory options, as appropriate. For example, FDA could require the companies to change the patient and physician labeling, or contact all patients through the mandatory tracking program.
Source: FDA
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21. How will FDA ensure that Allergan and Mentor complete their post-approval studies?
To assure that Mentor and Allergan (formerly Inamed) complete these studies, FDA will:
Track the post-approval studies, using a new electronic tracking system
Provide guidance on how and when companies should report the status of their post-approval studies
Post the status of the studies on our website to help keep the public informed
Hold open public Panel meetings on the status of the conditions of approval five and 10 years after approval, as well as any other time FDA decides is necessary (e.g., if significant new information from the post-approval studies becomes available)
Source: FDA
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