Patrick Hudson MD, FACS

The following forms are similar to the information Dr. Hudson will ask you to sigh before you have a breast augmentation.  The forms you actually sign will be similar but may not be exactly the same.  They are provided here so you have time to read them carefully and understand the material before you give your consent for your breast augmentation.  If you have questions you can email Dr. Hudson or call his office at 505-242-0070. 

Similar material is also available as a pdf file.

INSTRUCTIONS

This is an informed-consent document that has been prepared to help your plastic surgeon inform you about augmentation mammaplasty (mammoplasty), its risks, and alternative treatments.  

It is important that you read this information carefully and completely.  Please initial each page, indicating that you have read the page and sign the consent for surgery as proposed by your plastic surgeon. This package has eight (8) pages.

GENERAL INFORMATION

Augmentation mammaplasty is a surgical operation performed to enlarge the breasts for a number of reasons:

• To enhance the body contour of a woman, who for personal reasons feels that her breast size is too small.

•   To correct a loss in breast volume after pregnancy.

•   To balance breast size, when there exists a significant difference between the size of the breasts.

•  As a reconstructive technique for various conditions

The shape and size of the breasts prior to surgery will influence both the recommended treatment and the final results.  If the breasts are not the same size or shape before surgery, it is unlikely that they will be completely symmetrical afterward.

Silicone gel-filled implants and Saline-filled breast implants are available for cosmetic breast augmentation. The choice is yours. The FDA  reviews the safety of breast implants. All implants are reviewed periodically and the information you receive today may not be considered correct in the future as new information is made available.

Breast enlargement is accomplished by inserting a breast implant either behind the breast tissue or under the chest muscles.  Incisions are made to keep scars as inconspicuous as possible, usually under the breast, around the lower part of the areola, or in the armpit.  The method of inserting and positioning breast implants will depend on your preferences, your anatomy and your surgeon’s recommendation. I have told Dr. Hudson my choice regarding type of implant, shape of implant, surface of implant, position of implant, preferred incision and any other preferences.

ALTERNATIVE TREATMENT

Augmentation mammaplasty is an elective surgical operation.  Alternative treatment would consist of not undergoing the surgical procedure, the use of external breast prostheses or padding, or the transfer of other body tissues to enlarge breast size.

RISKS of AUGMENTATION MAMMAPLASTY SURGERY

Every surgical procedure involves a certain amount of risk and it is important that you understand the risks involved with augmentation mammaplasty.  Additional information may be obtained from the FDA, package-insert sheets supplied by the implant manufacturer, or other information pamphlets required by individual state laws.

An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit.  Although the majority of women do not experience the following complications, you should discuss each of them with your plastic surgeon to make sure you understand the risks, potential complications, and consequences of breast augmentation.

Bleeding- It is possible, though unusual, to experience a bleeding episode during or after surgery.  Should post-operative bleeding occur, it may require emergency treatment to drain accumulated blood or blood transfusion.  Do not take any aspirin or anti-inflammatory medications for ten days before surgery, as this may increase the risk of bleeding.

Infection- Infection is unusual after this type of surgery.  Should an infection occur, treatment including possible removal of the implant, antibiotics or additional surgery may be necessary.  It is extremely rare that an infection would occur around an implant from a bacterial infection elsewhere in the body.

Capsular contracture- Scar tissue, which forms internally around the breast implant, can tighten and make the breast round, firm, and possibly painful.  Excessive firmness of the breasts can occur soon after surgery or years later.  Although the occurrence of symptomatic capsular contracture is not predictable, it generally occurs in less than 20 percent of patients.  The incidence of symptomatic capsular contracture can be expected to increase over time.  Capsular contracture may occur on one side, both sides or not at all.  Treatment for capsular contracture may require surgery, implant replacement, or implant removal.  External pressure (closed capsulotomy) may break up scarring, but can potentially rupture the implant.

Change in nipple and skin sensation- Breasts are usually sore after surgery.  Some change in nipple sensation is not unusual right after surgery.  After several months, most patients have normal sensation.  Partial or permanent loss of nipple and skin sensation may occur occasionally.

Skin scarring- Excessive scarring is uncommon. In rare cases, abnormal scars may result.  Scars may be unattractive and of different color than surrounding skin.  Additional surgery may be needed to treat abnormal scarring after surgery.

Implants- Breast implants, similar to other medical devices, can fail.  Implants can break or leak.  When a saline-filled implant deflates, its salt water filling will be absorbed by the body.  Rupture can occur as a result of an injury, from no apparent cause, or during mammography.  It is possible to damage an implant at the time of surgery.  Damaged or broken implants cannot be repaired.  Ruptured or deflated implants require replacement or removal.  Breast implants do not have an indefinite lifespan and will eventually require replacement surgery.

Degradation of breast implants- It is possible that small pieces of the implant material may separate from the outer surface of breast implants.  This is of unknown significance.

Implant extrusion- Lack of adequate tissue coverage or infection may result in exposure and extrusion of the implant.  Skin breakdown has been reported with the use of steroid drugs or after radiation therapy to breast tissue.  If tissue breakdown occurs and the implant becomes exposed, implant removal may be necessary.

Mammography- If you are over 35 years of age, pre-operative mammography is recommended prior to surgery. Post-operative mammography is performed according to American Cancer Society guidelines.  Breast implants may make mammography more difficult and may obscure the detection of breast cancer.  Implant rupture can occur from breast compression during mammography.  Inform your radiologist of the presence of breast implants so that appropriate mammogram studies may be obtained.  Ultrasound, specialized mammography and MRI studies may be of benefit to evaluate breast lumps and the condition of the implant(s).

Skin wrinkling and rippling- Visible and palpable wrinkling of implants can occur.  Some wrinkling is normal and expected.  This may be more pronounced in patients who have saline-filled implants or thin breast tissue. It can occur in all implants and is more common in textured and in saline implants.

Pregnancy and breast feeding- There is insufficient evidence regarding the absolute safety of breast implants in relation of fertility, pregnancy or breast feeding.  While there is no convincing evidence of any special danger of breast implants for pregnant women or their children, studies are continuing to look for possible problems.

Calcification- Calcium deposits can form in the tissue surrounding the implant and may cause pain, firmness, and be visible on mammography.  Should this occur, additional surgery may be necessary to correct his problem. 

Immune system diseases and unknown disorders- Some women with breast implants have reported symptoms similar to those of known diseases of the immune system, such as systemic lupus erythematosis, rheumatoid arthritis, scleroderma, and other arthritis-like conditions.  These symptoms include joint pain or swelling, fever, fatigue, thyroid problems, breast pain and musculoskeletal pain.  A connection between implanted silicone and connective-tissue disorders has been reported in the medical literature.  To date, there is no scientific evidence that women with either silicone gel-filled or saline-filled breast implants have an increased risk of these diseases, but the possibility cannot be excluded.  If a causal relationship is established, the theoretical risk of immune and unknown disorders may be low.  The effects of breast implants in individuals with pre-existing connective-tissue disorders is unknown.  Patients who have gel implants will receive additional information to explain these implants.

Unlike silicone gel-filled implants, the saline-filled implants contain salt water.  However, gel-filled and saline-filled devices have a silicone rubber envelope.  An increased risk of autoimmune disease is possible even from saline implants.  Reliable medical laboratory tests to determine antibodies to silicone do not exist.  It has not been proved that there is a relationship between silicone antibodies and disease in women with breast implants.  Currently, there is insufficient evidence to state that there is a health benefit from removing breast implant(s) and scar-tissue capsule(s) will alter autoimmune disease or prevent its potential occurrence.

In very few women who have breast implants, a variety of other symptoms and conditions have been reported, suggestive of an auto-immune multiple-sclerosis-like syndrome.  Additional complaints involve the musculoskeletal, skin, nervous, and immune systems. The relationship of breast implants to these conditions has been hypothesized, although not scientifically proven.  Because such disease states are rare, they are difficult to research.  There is the possibility of unknown risks associated with silicone breast implants and tissue expanders.

Surface contamination of implants- Skin oil, lint from surgical drapes, or talc may become deposited on the surface of the implant at the time of insertion.  The consequences of this is unknown.

Chest wall deformity- Chest wall deformity has been reported secondary to the use of tissue expanders and breast implants.  The consequences of chest wall deformity is of unknown significance.

Unusual activities and occupations- Activities and occupations which have the potential for trauma to the breast could potentially break or damage breast implants.

Allergic reactions- In rare cases, local allergies to tape, suture material, or topical preparations have been reported.  Systemic reactions which are more serious may occur to drugs used during surgery and prescription medicines.  Allergic reactions may require additional treatment.

Breast disease- Current medical information does not demonstrate an increased risk of breast disease or breast cancer in women who have breast implant surgery for either cosmetic or reconstructive purposes.  Breast disease can occur independently of breast implants.  It is recommended that all women perform periodic self examination of their breasts, have mammography according to American Cancer Society guidelines, and to seek professional care should they notice a breast lump. 

Surgical anesthesia- Both local and general anesthesia involve risk.  There is the possibility of complications, injury, and even death from all forms of surgical anesthesia or sedation. All surgery carries risks of thrombosis and embolism (blood clot or fat) that can have serious consequences even death.

Removal/replacement of breast implants-Future removal or replacement of breast implants and the surrounding scar tissue envelope involves a surgical procedure with risks and potential complications. 

Other- You may be disappointed with the results of surgery.  Asymmetry in implant placement, breast shape and size may occur after surgery.  Unsatisfactory displacement or poor surgical scar location may occur.  It may be necessary to perform additional surgery to improve your results. 

FDA - The FDA has special recommendations regarding gel implants, including information about MRI scans and additional surgery,  and a separate information sheet will be provided for you, if you do not receive this please speak to either the office manager or Dr. Hudson.

HEALTH INSURANCE

Dr. Hudson does not accept any kind of health insurance. Neither he nor his staff complete insurance forms. 

FINANCIAL RESPONSIBILITIES

The cost of surgery involves several charges for the services provided.  You are responsible for these fees. The total includes fees charged by your doctor, the cost of surgical supplies and implants, laboratory tests, anesthesia, and hospital charges, depending on where the surgery is performed. Additional costs may occur should complications develop from the surgery.  Secondary surgery or hospital-day surgery charges involved with revisionary surgery would also be your responsibility. 

REFUNDS AND GUARANTEE 

Refunds are not given. No guarantee can or will be given about the outcome of surgery and your satisfaction.

ADDITIONAL SURGERY NECESSARY

Should complications occur, additional surgery or other treatments may be necessary.  Even though risks and complications occur infrequently, the risks cited are particularly associated with augmentation mammaplasty; other complications and risks can occur but are even more uncommon.  The practice of medicine and surgery is not an exact science.  Although good results are expected, there is no any guarantee or warranty expressed or implied, on the results that may be obtained. 

DISCLAIMER

Informed-consent documents are used to communicate information about the proposed surgical treatment of a disease or condition along with disclosure of risks and alternative forms of treatment(s).  The informed consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances.  

However, informed consent documents should not be considered all inclusive in defining other methods of care and risks encountered.  Your plastic surgeon may provide you with additional or different information which is based on all the facts in your particular case and the state of medical knowledge.

Informed-consent documents are not intended to define or serve as the standard of medical care.  Standards of medical care are determined on the basis of all of the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve.

It is important that you read the above information carefully and have all of your questions answered before signing  these consent forms.

CONSENT FOR SURGERY/ PROCEDURE or TREATMENT

1.I hereby authorize Dr. Patrick Hudson and such assistants as may be selected to perform breast enlargement with implants

I have received the following information sheets: 

INFORMED-CONSENT FOR AUGMENTATION MAMMAPLASTY 

2.I recognize that during the course of the operation and medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than those above.  I therefore authorize the above physician and assistants or designees to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable.  The authority granted under this paragraph shall include all conditions that require treatment and are not known to my physician at the time the procedure is begun.

3.I consent to the administration of such anesthetics considered necessary or advisable.  I understand that all forms of anesthesia involves risk and the possibility of complications, injury, and sometimes death.

4.I acknowledge that no guarantee has been given by anyone as to the results that may be obtained.

5.I consent to the photographing or televising of the operation(s) or procedure(s) to be performed, including appropriate portions of my body, for medical, scientific or educational purposes, provided my identity is not revealed by the pictures.

6.For purposes of advancing medical education, I consent to the admittance of observers to the operating room.

7.I consent to the disposal of any tissue, medical devices or body parts which may be removed.

8.I authorize the release of my Social Security number to appropriate agencies for legal reporting and medical-device registration if applicable.

9.IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:

a.THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN

b.THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT

c.THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED

I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS (1-9).  I HAVE BEEN ASKED IF I WANT A MORE DETAILED EXPLANATION, BUT I AM SATISFIED WITH THE EXPLANATION AND DO NOT WANT MORE INFORMATION.

______________________________________________________

Patient or Person Authorized to Sign for Patient

Date____________________   

___________________________

Witness      

Permit form for breast augmentation or enlargement with implants

NAME:____________________________________________

DATE : __________________

I give Dr.  Patrick Hudson permission to perform an operation called breast augmentation or breast enlargement with implants.

My diagnosis (what is wrong with me) is breast hypoplasia or small breasts.

I understand that surgery is not exact and that there has not been a guarantee of a particular end result.

I give permission for an anesthetic which will be given by Dr.Hudson if I am awake (local anesthetic) or under the direction of the hospital anesthesiologist if I go to sleep (general anesthetic).

I understand the risks of breast augmentation or breast enlargement with implants to include but not be limited to: 

• capsule formation (hardness of the breast area) and malposition of implants

• bleeding or hematoma

• numbness and sensory change

• implant rupture or leakage which may require replacement

• heavy scar

• breast feeding may not be possible after this surgery

• asymmetry of breast position, shape or size and/or incision asymmetry

• wrinkling or irregularity of implant surface may be felt or seen

I understand that all operations have some risk such as bleeding, infection, sensory changes, scarring, swelling and poor healing.  I also realize that there are risks to any anesthetic and these risks include abnormal reaction to the medicine. The risks of a general anesthetic include thrombophlebitis, pulmonary embolism, pneumonia, atelectasis and death.

If during the operation Dr.Hudson finds something which was not expected I give permission for him to do what he thinks is the best medical treatment at that time.

I understand that it is sometimes necessary to perform more than one operation to complete my treatment or if complications occur.  I accept that the costs for such operations will be paid by me. I understand that I will select an implant with Dr. Hudson's help and that if in the future I wish for a change, such as a different shape or larger breasts, there will be additional charges.

I understand that if capsules develop Dr. Hudson may have to release the capsule either with surgery (open capsulotomy) or by firmly massaging the breast (closed capsulotomy).  The release of a capsule does not guarantee that the capsule will not return and capsulotomy may need to be repeated.  I understand that closed capsulotomy has the risk that the implant may be damaged, bleeding may occur and that the capsule may break unevenly causing the breast to have an uneven shape.  Sometimes after a closed capsulotomy surgery may be required if a problem occurs. I understand that Dr. Hudson will not charge a surgical fee for release of the capsules during the first year after surgery but after this a charge will be made to surgically release the capsule. I understand that at all  times I am responsible for all fees other than the surgeon's fee .

I understand that after breast implantation mammograms may be more difficult to interpret and that extra views may be needed.

I understand that Dr.Hudson does not give any guarantee or warranty either written or implied for the implant and that I accept the warranty of the manufacturer of the implant for durability, safety, long term use and effects, etc..  

I understand that Dr. Hudson will usually use implants filled with saline and made with an outer envelope of silicone plastic (silastic) OR at my request gel implants. Dr. Hudson has discussed with me the possible health aspects of the implants, such as breast cancer and immune problems. I understand that saline implants are filled with salt water and do not feel or look like normal breast tissue.

I understand that new information may become available and may be different from the information received in the office for this operation and I do not hold Dr. Hudson responsible for this.

I understand that when  the operation is performed under local anesthetic, complete pain relief is not always possible. If this happens  and he feels the operation is too difficult for the patient, Dr. Hudson may discontinue the operation under local anesthetic and recommend it is continued under general anesthetic. This may be either at that time or at a later date.

My signature indicates that I have read all of the above and understand it to my satisfaction.  I have been told the risks of the operation and my questions have been answered.

I understand that General Anesthetic has risks and complications and that I will discuss these with the anesthesiologist before surgery to my satisfaction.

I give permission for the operation to be performed and for closed capsulotomy to be performed after surgery if needed.

Signature:                                        

Witness:                                                                                           

Date: