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(Look for breast implants at the FDA web site at http://www.fda.gov )
Poor health of various sorts, such as
bleeding tendencies, hypertension, heart disease, chronic pulmonary, renal and
hepatic diseases, acute and chronic skin, ear, or periodontal infections may be
problems. Keloid and excessive scar formers are not only more likely to have
problems with the incision site scars, but are also more prone to capsular
contracture. A person with dermatographia may also be more prone to capsules.
Chest wall deformities can be a
contraindication to surgery. One such deformity is Poland's
Syndrome, which occurs in males and females and is associated with
unilateral lack of the pectoralis major muscle, mammary hypoplasia, and other
abnormalities of the upper extremities, such as syndactyly. The more severe
cases of pectus excavatum and markedly hypoplastic breasts can be problems,
especially when capsule contracture occurs and causes distortion.
As described in the preoperative counseling
section, the patient with pendulous breasts presents a challenge. Only the grade
IV type will clearly be made to look worse by augmentation, and this is because
the bulk of the implant will sit above the nipple and increase the downward
The Grade III with the nipple above the
inframammary fold, or the small breast that can have the inframammary fold
lowered, may still be a good candidate, if the patient is fully informed and has
realistic expectations of the results. In other words the patient with pendulous
breasts who is to have augmentation is more likely to be pleased if she knows
beforehand how she will look after surgery. This information can best be
conveyed to the patient by allowing the patient to see clear photographs of the
results of patients with a similar amount of sagging. Another alternative is to
take photographs of the patient and sketch on copies of them the expected
appearance and change in contours from surgery.
The patient with gross asymmetries such as
different size areola, nipples pointing in different directions, having one
inframammary fold higher than the other, having one breast hypertrophied or more
pendulous than the other, inversion of one nipple, etc. should have these issues
clearly documented on photographs and preferably will give consent in writing
that she understands the surgical procedure cannot correct these problems.
Very often the patient seeking augmentation
will have been pregnant and will wish for implants to fill up the breasts as
they were during pregnancy and breast feeding. This is a very reasonable
request, and one with which the surgery can comply.
If, however, the surgeon performs the
operation while the patient is still lactating, which is at a time when there is
still more than a few drops of milk that can be expressed by mild pressure on
the breasts, then the pressure even of subpectoral placement of implants will
cause milk to accumulate around the implants, very frequently leading to severe
Usually the patient who has been
breast-feeding should wait for a month or more before considering breast implant
surgery. Sometimes the patient is very insistent because she does not want to be
small, flat, and unattractive, even for a few weeks. This insistence is a trap
for the surgeon.
It is better to wait six months or more. The
breast milk around the implant is referred to as Galactorrhea. Severe capsule
contracture is the usually result.
Other than physical contraindications, the
most common can be divided into mental and financial. It is not necessary to be
extremely wary of psychiatric problems in patients seeking breast augmentation.
They are certainly no more common than with any other cosmetic surgical
Many years ago there was a reasonable opinion
that persons seeking cosmetic surgery were mentally or emotionally unstable.
Perhaps there was some truth when the risks of the procedures were much greater,
and the results were less satisfying and predictable. It certainly is not true
The patients seeking improvement in
appearance by reasonable and tried and true methods are among the most aware and
intelligent of our society. Some of our presidents and all of the president's
wives since the Nixons in the early seventies have had cosmetic surgery except
The vast majority of persons seeking
improvement in appearance by breast augmentation and other procedures are as
mentally stable as those who go to the beauty shop or the cosmetics counter with
the same motives. Occasionally though, we see patients who are mentally ill,
simply because a significant percentage of the population falls into that
category. We cannot discuss all of these patients but some deserve special
Hopefully, the physician will recognize the
severely depressed and the psychotic patient with a distorted sense of reality.
Even these persons can recover and have their surgery performed at a later time.
The milder mental problems are more difficult to recognize, and are not really
mental illnesses at all, but can cause the surgeon some anxieties if he doesn't
deal with them properly.
They are more like attitudes people have. For
example, very rarely a person will be seen who really doesn't want the operation
for herself, but is doing it to please someone else, or even worse, to
accomplish a specific goal, such as to get her husband back. This desire is
easily uncovered and recognized by the physician interviewing the patient by
asking the simple question, "Why do you want this operation?"
The simple answer is, "To look
better." This is what we hope
to hear, but when we hear other goals that may not be achieved, and are
secondary goals, it is important that the patient understands that the surgery
will not necessarily accomplish secondary goals even when it has been very
successful in the primary goal of making the breasts larger and more attractive.
The patient with unrealistic expectations is
the most common potential problem. Normal and even very intelligent people
expect not to have any problems. They expect that if they pay a good doctor
thousands of dollars for a breast operation, they can reasonably expect to have
This is why the preoperative counseling and
the informed consents are so important. The judge and jury feel the same way,
and will not accept any verbal assurances from the doctor that he informed the
patient. It must be in writing and signed by the patient, witnessed etc., that
the patient understands there are serious and common complications to breast
surgery. Here is an
example of a consent form that might help individuals understand some of the
problems related to health when considering breast surgery.
CONSENT FOR BREAST IMPLANT SURGERY
PERMISSION IS HEREBY GRANTED TO THE DOCTOR AND ALL OF THE ASSISTANTS TO
PERFORM THE FOLLOWING SURGERY:
Permission includes the administration of medicines for local or general anesthesia and/or intravenous sedation or analgesia as deemed suitable or as becomes necessary. An informed consent requires that common complications are made known to you. Most of these are not expected to occur. All must be considered. The law requires that you are informed.
1. MEDICATION: Unfavorable reaction to prescribed medications or anesthesia can occur. This may include nausea, vomiting, allergic reactions with skin rash and itching to more severe reactions including convulsions, coma or death.
2. EDEMA (Swelling): This occurs to some degree after every surgery. It may last days, weeks or months. Some swelling may remain after surgery for a year or more. You will be given special instructions or treatment if appropriate.
3. BLEEDING: This is controlled at the time of surgery by sutures, cautery or pressure. Hematoma (blood clot) may require removal. Some bloody drainage on dressings is normal. If bleeding occurs, phone our office. If we cannot be reached promptly, and there are problems that are of concern, go to the nearest hospital emergency room, and tell our answering service where you are going. In a very rare case, extensive bleeding or other complications could require hospitalization and blood transfusion. With most surgery there is bleeding under the skin that leaves a bluish discoloration (bruising) for two or more weeks.
4. INFECTION: This may require implant removal and replacement with a new implant at a later time. Infection may occur with any break in the skin or with any operation, or following pregnancy . When infection occurs around a breast implant, then the implant will probably have to be removed. It may occur on only one side. When the implant is removed it is necessary to leave it out for a period of months to be sure that the tissues are completely free of infection before it is replaced. It is sometimes necessary to wait six months or more before replacing the implant.
5. SCARRING: Some scar will result wherever there is a cut. We make every effort to place scars in areas where they will be minimal or invisible. Healing and tendency to scar is very variable in different persons and in different areas of the body of the same person. How well a person will heal cannot be exactly predicted or controlled. Extensive wide or thickened scars (hypertrophic or keloid) may occur if you are prone to them.
6. NUMBNESS: In cutting the skin, small nerve endings are also cut that can result in numbness around or adjacent to the surgical area. Sensation usually returns in a matter of months or years as the small nerve endings re-grow. Rarely is an area permanently numb. Most numbness or weakness goes away in time. It is unequal on the sides of the body.
7. RESPIRATORY AND HEART FAILURE: These are unusual complications of anesthesia. They are, however, known risks. Heart attack or stroke may occur.
8. PNEUMOTHORAX AND SEROMA: Pneumothorax (life threatening lung collapse due to air in the chest and tissues around but outside of the lungs) may occur and may require hospitalization, chest tubes and additional incisions and treatment. Seroma is a fluid collection of serum around one or both implants as a reaction to the implant. This may require treatment, medicines, drainage and could require removal of one or both implants as described for infection.
9. PHOTOGRAPHS: I consent to be PHOTOGRAPHED before, during and after the treatment. I agree that these photographs become the property of the doctor, to be used as he deems proper. I consent to the publication of these photographs in any journal, article, magazine, internet or book. My permission is granted to show these photographs to any other physicians, patients or persons.
10. FOLLOW UP CARE AND APPOINTMENTS: I agree to keep the doctor informed of any change of address and phone numbers, and I agree to cooperate with the doctor in my care after surgery until completely discharged. I will make and keep follow up appointments, take medications and follow other instructions as prescribed.
11. POSTOPERATIVE DEPRESSION is common after any form of cosmetic surgery. Such depression is usually related to the immediate postoperative discomfort, anxiety over a distorted appearance (swelling and bruising) and limitation of activities and socializing. As your appearance improves and you return to your usual activities and interests these feelings should disappear.
12. MEDICAL HISTORY: I have given a complete history of previous surgery and hospitalizations and all previous physical and mental illnesses in writing on a separate form, including all medications or drugs that have been taken, are being taken or to which I am allergic.
13. ADDITIONAL PROCEDURES: I authorize the surgeon to perform any other procedures which he may deem necessary or desirable to correct any unforeseen condition encountered during surgery for the purpose indicated above.
14. HOSPITAL ADMISSION: I understand that treatment of any unusual or serious complications requiring admission to a hospital is not covered by way of cost or charges quoted in connection with this surgery. In addition, I have been made aware that such complications could require the service of additional physicians and none of these fees or charges are included.
15. SYMMETRY: It is understood that the two sides of our bodies are different and asymmetrical and this includes the chest, breasts, nipples, and all other parts of our faces and bodies. While we usually want to make our two sides more alike, it is understood that it is not possible to make them alike. The two sides of our bodies and of every part of our breasts will always be different unequal and asymmetrical in every way to some degree.
16. REVISIONS: When we have cosmetic surgery we want an improvement in appearance and want to look as good as possible. Even after the surgery is done, most of us still want to look better. This may be true when the surgery has been very successful. Sometimes because the appearance is improved with so little discomfort the patient wants more. Many patients want to look better than is possible. The expectations may be greater than the doctor can achieve. The results of surgery are never perfect. The results can never match a preconceived drawing, picture or goal. If further surgery is desired to look better even of the same part that was done there will be additional charges. Though the patient may want more improvement, the surgeon may believe the risks outweigh the rewards to the patient. It is understood there will be some additional charges for revision surgery or repair work done.
17. SAGGING OF THE BREAST: While women with breast implants may sag no more than those of the same size without, the implants do have some weight and can cause some additional sagging of the breasts as can pregnancy, weight gain and aging.
18. WRINKLING OR RIPPLING: The textured implants have a thicker wall than the slick implants. They are made textured to stay softer and not allow capsule formation. The thicker wall that is required for the textured surface causes wrinkling or rippling that can be seen after surgery through the skin. If the breast tissue is very thin these wrinkles can show as visible ripples, especially when you lean forward without wearing a brassiere. The wrinkling can also produce little corners on the implants that can sometime be felt with the finger if the breast tissue is very thin. The corner or fold that is palpable or visible may mimic a breast lump and require surgery or may perforate the skin and lead to extrusion or loss of the implant.
19. CAPSULE CONTRACTURE: The most common problem with any type of breast implant is firmness due to capsule contracture. The incidence varies with the type of implants. With steroids, massage, decompression, sub-muscular position, saline, textured and polyurethane implants there may be less capsule firmness but there can be other problems that may far outweigh the advantages. Hardness and deformity in appearance often follow pregnancy.
20. INCISION SITE, LOCATION, SIZE, SHAPE AND IMPLANT SIZE, SHAPE, POSITION, LOCATION, AND TYPE: Though these factors may be discussed and the patient's wishes may be followed as much as is prudent and reasonable, the patient must agree to whatever can be done for the patient with respect to all of these factors and must agree to whatever treatment or surgery is necessary, advisable or available at the time of and during the operation. Permission is granted for other incisions, implants or treatments as may be needed. No certain preconceived appearance or result can be obtained. Other incision sites may be needed later if there are problems especially with the underarm incision.
REJECTION OR EXTRUSION: The body may recognize the implant as a foreign object and try to reject it. The capsule contracture problem of becoming too hard may be part of the rejection phenomenon. Occasionally the implant may be pushed from the inside by the rejection process against the skin causing it to become very thin and a "blue window" may occur. The implant may be pushed against the skin until the skin over the implant breaks and the implant becomes exposed. When this occurs the implant extrudes or is removed. It may be necessary to wait several months before putting a new implant back in.
IMPLANT RUPTURE: Implants may rupture at any time following surgery even without apparent cause. The most common cause of rupture is injury. A ruptured gel implant may result in gel migration, inflammation, and formation of silicone granulomas. Additional surgery may be required to remove the implant and the gel. The long term effects of silicone gel on the body with a ruptured implant are unknown.
23. DISPLACEMENT AND DISTORTION: Implants may become displaced, or distortion in breast shape and appearance may occur. This is usually a part of the capsule contracture phenomenon. The implants may seem to be too high or too low, too far to the side, or in any other conceivable abnormal and unequal position. The tissues and skin over the sternum or breast bone may eventually lift forward causing an apparent communication from one side to the other. This may require further surgery. Not all problems can be corrected. Many problems in appearance cannot be corrected or improved.
24. SKIN NECROSIS: Skin over a portion of the implant may become very thin and break. The implant may become exposed and require removal. Then it may be best to wait six months for replacement with a new implant.
25. GEL BLEED: All implants filled with silicone gel may leak or bleed through the shell even when the implant is not ruptured. The long term effects of gel bleed are unknown. Over many years gel bleed could be harmful.
26. LEAKING IMPLANTS AND DEFLATION: Saline filled implants are expected to leak and eventually collapse. Though the saline is not harmful to the body, if the leakage and deflation are only on one side then this may cause distortion in appearance. It is estimated that noticeable loss of saline will occur in as many as 50% or more persons who have saline implants for seven or more years. Further surgery is required to replace the implants at additional cost.
27. CHANGE IN NIPPLE SENSATION: Some numbness is expected with each operation. The numbness is most often in the lower portion of the skin below the nipple. Usually there is some numbness of the nipples from breast implant surgery. Most of the numbness goes away in a period of months or years. Some numbness may be permanent and unequal. There also may be hypersensitivity.
28. INTERFERENCE WITH MAMMOGRAPHY: The presence of breast implants of any type interferes with mammography and early detection of breast cancer. Mammograms may be more uncomfortable since they require squeezing the breast with pressure. The pressure of mammography may rupture an implant or cause implant deflation with saline implants. The standard recommendations of the American Cancer Society should be followed for when to have mammography. ACS recommends that at age 35 to 40 a base line mammogram should be done. Between ages 40 and 50 mammograms should be done every one to two years. Women over fifty should have a mammogram every year. Mammograms should be done more frequently when there is a family history of breast cancer.
29. AUTOIMMUNE DISEASE: Some women with breast implants have developed scleroderma, which is a serious disabling and potentially fatal connective tissue disease. Some women have developed arthritis like diseases such as, lupus and rheumatoid arthritis after breast implant surgery. According to the Federal Drug Administration, September 26, 1991, "There is no conclusive evidence at present that women with breast implants have an increased risk of developing arthritis-like diseases or other autoimmune diseases. Women with breast implants who have developed such diseases may have done so regardless of their implants."
30. BREAST FEEDING: Many patients have become pregnant and have breast fed infants after breast implant surgery. Breast implants may interfere with breast feeding in many different ways. There may be numbness or hypersensitivity of the nipples. There may be tenderness or inadequate milk production. Pregnancy after breast implant surgery may cause stretching of the skin and deformity of the shape of the breast or stretch marks of the skin. It is possible that there could come some harm to the infant who is breast fed from breasts with implants. Potential harmful effects are unknown.
31. AXILLARY INCISION: The axillary incision, under the arm or in the armpit, may cause more tenderness and discomfort after the operation, especially with movements of the arms, than the incisions on the breasts or chest wall. In addition there may be numbness of the arms around the incision or of part of the upper arms, the forearms or the hands and fingers. There also could be interference with circulation of the upper arms or hands that may cause a tendency to have numbness, tingling or swelling of the hands. These problems are uncommon but could occur even when the surgery is perfectly performed. Another incision site may be necessary if there are problems at this surgery or a later surgery.
BREAST CANCER AND IMPLANTS: Breast implants interfere with early detection of breast cancer. This could mean that women with breast implants have a reduced cure rate with breast cancer. Approximately two million American woman have breast implants. While women with breast implants have not been shown to have an increased risk of breast cancer, and according to the FDA "there is no evidence at present that women with breast implants are at increased risk." Studies are still in progress and the results may not be known for many years to come.
33. RISK TO UNBORN BABIES: Possibilities of risk to unborn babies cannot be ruled out. According to the FDA "there is no evidence at present that women with breast implants or their unborn babies are at increased risk."
34. STEROID ATROPHY: Steroids, such as cortisone, may be used in or around the breast implants at the time of surgery to prevent capsule contracture. Steroid atrophy may occur with thinning of the skin and the tissues around the implants. This may lead to a blue appearance around the border of the breast due to the visibility of the implant through the skin. The skin may stretch and the breasts may sag. Further surgery may be required if this occurs.
35. SYMMETRY AND ASYMMETRY: No two breasts are alike and in some women they are very different. Breast implant surgery may make the unequal appearance of the breast better or worse. The breasts can not be made equal or alike.
36. DEFORMITIES OF APPEARANCE: Many deformities and disfigurements of appearance occur after breast implant surgery. Among these are a stuck on appearance, nipples pointing up or down, the ball in the sock appearance, the double bubble deformity, the uni-breast, unequal size, shape and direction of pointing of nipples, sagging, as well as too much or too little cleavage and many others.
37. STRETCH MARKS OR STRIAE: Stretch marks, such as of the skin of the abdomen following pregnancy, may occur in the breasts. They may not occur until after pregnancy or many months or years later. Birth control pills seem to cause them in some persons.
38. MUSCLE MOVEMENT: Implants that are placed below the pectoral muscle may move whenever the muscle is contracted in normal movements of the arms. This may also cause visible distortion of the appearance of the breasts with movement of the arms. Occasionally the movement is so annoying the woman has further surgery to put the implants above the muscles because of this problem.
39. MUSCLE WEAKNESS: Whenever the implants are placed below the muscles, there is some weakness of the muscle because of the injury to the muscle itself or the nerve and blood supply to the muscle. The muscle is partly detached from the ribs and is otherwise injured by the surgery.
40. DOUBLE FOLD OR BUBBLE: A fold in addition to the new inframammary fold may occur in the lower part of the breast. This is due to a persistence of the normal inframammary fold or crease. It can cause a double bubble appearance which may or may not improve in time.
41. IMPLANT DURATION: Implants last many years in some women and have to be replaced more frequently in others. The person choosing breast implants should expect to require further surgery to repair the implants in the future, especially if they are saline filled.
42. UNKNOWN RISKS: Although there are many risks that are known that can be described, most risks are still unknown.
43. LONG TERM RISKS: According to the FDA " The two greatest concerns to most women with implants are cancer and autoimmune disease. But at this time there is no proven association with breast implants and the development of these diseases." FDA BG, Aug 1991.
44. ADDITIONAL COSTS: Many of the problems, known and unknown, that can occur and may be related to breast implants may cause need of additional treatment or surgery or prolonged illness, disability, hospitalization, disease, deformity, disfigurement and death. Any or all of these may require additional expenses and costs to the person having breast implant surgery or her family.
45. ABNORMAL APPEARANCE OR FEEL: Implants are usually detectable . They may look or feel more firm. They may not move or jiggle the same as normal. The implants may be palpable. The valve may be palpable and the implant can often be felt through the skin. They may look "stuck on", too high, too low or unequal.
46. SATISFACTION: Cosmetic surgery is inexact and can be complicated. To achieve an improvement in appearance we undergo serious risks of discomfort and the possibility of looking worse than we did before with severe disappointment. There can be NO GUARANTEE that either YOU OR ANYONE ELSE WILL BE SATISFIED OR PLEASED WITH THE RESULT.
47. NO GUARANTEE: I am aware that the practice of medicine and surgery is not an exact science, and I acknowledge that no guarantees have been made to me as to the results of the operation or procedure. IT IS UNDERSTOOD THAT MY RESULT CANNOT BE LIKE ANY PICTURES OR DRAWINGS OR ANY PRECONCEIVED IDEA OR GOAL.:
Our patients are offered a copy of any form they sign.
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