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There are many variations on how plastic surgery is practiced in

By Alicia Wright,2014-06-26 18:59
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There are many variations on how plastic surgery is practiced in

    INFORMED CONSENT ALLODERM? REGENERATIVE TISSUE MATRIX

    There are many variations on how plastic surgery is practiced in terms of practice orientation and preferences of surgical procedures. The sample consent documents found in the ASPS Patient

    Consultation Resource Book serve as a framework for the creation of additional informed-consent

    documents, depending on the needs of the individual plastic surgeon and his or her practice of the specialty.

    The following pages represent a blank consent template with basic page formatting and layout for the creation of your own informed-consent documents. When writing your own informed-consent documents, develop a style of writing that avoids medical jargon, abbreviations, or other words that are not easily understood by the patient. Informed-consent documents have an educational purpose in addition to risk disclosure.

    Feel free to “borrow” identifiable risk factors and subsequent text from the sample consent documents provided. The copy and paste functions found within a word-processing program allow you transport blocks of text between different documents. This will save significant amounts of time since you will not have to re-type material. The blank template contains “XXXXX” to indicate where a procedure name needs to be

    added. Bold type makes the place for you to add additional material relating to the proposed surgical procedure. Other risk factors that are procedure-specific would be written into the informed-consent document as needed.

    Once you have completed the writing of your own procedure-specific informed-consent document, remember to adjust the “page # of page #” to the bottom of the page, add the procedure name to the institutional-style consent, and perform a spell-check on the document. You may want to add letterhead or title information as discussed in the chapter, “Desktop Publishing”.

Finally, before you “roll the presses,” it is a good idea to have your informed-consent documents reviewed

    by your malpractice carrier or attorney to make certain that you have met specific requirements concerning risk disclosure. It may be worthwhile to have some of your patients and staff assist with the “fine tuning” of your informed-consent documents.

    INFORMED CONSENT ALLODERM? REGENERATIVE TISSUE MATRIX

INSTRUCTIONS

    This is an informed-consent document that has been prepared to help inform you about ACELLULAR

    DERMAL GRAFT (ALLODERM?) surgery, its risks, as well as alternative treatment(s).

    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 and agreed upon by you.

GENERAL INFORMATION

    AlloDerm? is an acellular dermal matrix derived from donated human skin tissue supplied by US AATB-compliant tissue banks utilizing the standards of the American Association of Tissue Banks (AATB) and Food and Drug Administration's (FDA) requirements. The tissue goes through a cell removal process while retaining the important biochemical and structural components. Since AlloDerm? is regarded as minimally processed and not significantly changed in structure from the natural material, the FDA has classified it as banked human tissue.

    Since AlloDerm? is derived from human tissue, there may be a concern that it might harbor disease carrying viruses. Tissue donors are screened and tested for transmissible diseases including HIV, hepatitis, and syphilis before tissue processing. A comprehensive review of the donor's medical records and social history is completed and released by a medical director before allowing the tissue to be processed. Additionally, LifeCell tissue grafts undergo a patented process that cleans and removes the cellular components while preserving and stabilizing the biochemical and biomechanical properties of the grafts. Finally, before

    AlloDerm? is released for use, additional tests are performed to assure patient safety.

    AlloDerm? repairs damaged tissue by providing a foundation for new tissue regeneration. The skin components preserved in AlloDerm? supports your own tissue to grow into the AlloDerm? after placement at the repair site. After the procedure, blood will flow from your tissue into the preserved vascular channels in AlloDerm?. This is a critical event, as it paves the way for tissue regeneration. Next, your own cells will move into AlloDerm? and begin the process of new tissue growth or tissue regeneration. This is the same process that your body uses to replace cells that your body sheds as part of your body's regular maintenance cycle. As the healing progresses, more and more of your cells will move into AlloDerm? and transform it into tissue that not only resembles your own but also functions like your own.

ALTERNATIVE TREATMENTS

    Alternative forms of non-surgical and surgical management consist of

Autograft

    An autograft involves taking your own tissue from another part of your body for the repair. Using your own tissue is a good option, as it will not be rejected by your body. The autograft is accepted by your body and can restore the structure and function in the area of placement.

    But, you would have to face two surgeries instead of one - one at the repair site and the other at the site where tissue for the repair is taken (referred to as the donor site). In addition, you could have complications such as infection, and healing might leave a scar at the donor site.

    You could also have complications at the repair site: the donor tissue could be damaged, leading to inflammation; the donor tissue could die, leading to transfer failure and leaving you with two surgical sites and still no repair; or the donor tissue could tear while it is being stitched, leading to problems in healing.

SyntheticMaterials

    Synthetic materials, such as meshes, made of materials like ePTFE (expanded polytetrafluoroethylene) and polypropylene can be used as alternatives to your own tissue for repair. The repair process for these materials is based not on regenerative healing, but on scar formation in and around the mesh.

    Page 1 of 6 Patient Initials 5-01-05 version ??2005 American Society of Plastic Surgeons.

    INFORMED CONSENT ALLODERM? REGENERATIVE TISSUE MATRIX

    The advantage of using these materials is that they do not present the donor site issues encountered with using your own tissue for repair. They are strong and do not tear easily, are readily available, inexpensive, and have a long history of being used for soft tissue reinforcement.

    However, use of synthetic materials is not without problems. As a foreign material, your body may react to its presence by growing around it (encapsulation) in an attempt to exclude it from your body. In the process, your tissue forms a capsule of rigid, fibrous scar tissue around the synthetic material. The rigid capsule could affect the function and the aesthetic outcome of the repair. Furthermore, foreign bodies such as synthetic materials increase the risk of infection when implanted in the body. As part of the foreign body response, the repair site may be subjected to inflammation, infection and pain.

    Risks and potential complications are also associated with alternative surgical forms of treatment.

RISKS OF ACELLULAR DERMAL GRAFT SURGERY

    Every surgical procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your plastic surgeon to make sure you understand all possible consequences of acellular dermal graft surgery.

    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. Intra-operative blood transfusion may also be required. Hematoma may contribute to capsular contracture, infection or other problems. Do not take any aspirin or anti-inflammatory medications for ten days before or after surgery, as this may increase the risk of bleeding. Non-prescription “herbs” and dietary

    supplements can increase the risk of surgical bleeding. Hematoma can occur at any time following injury to the breast. If blood transfusions are necessary to treat blood loss, there is the risk of blood-related infections such as hepatitis and HIV (AIDS). Heparin medications that are used to prevent blood clots in veins can produce bleeding and decreased blood platelets.

    Infection- Infection is unusual after surgery. Risk of infection is increased when inserting foreign materials into the body. Should an infection occur, additional treatment including antibiotics, hospitalization, or additional surgery may be necessary. Infections with the presence of a breast implant (if used) are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the breast implant may have to be removed. After the infection is treated, a new breast implant can usually be reinserted.

    Disease Transmission- Alloderm? implants have undergone rigorous donor screening, serological testing, and a patented process that cleans and removes the cellular components while preserving and stabilizing the biochemical and biomechanical properties of the grafts; however, there is some theoretical risk for disease transmission.

    Change in Skin Sensation- It is common to experience diminished (or loss) of skin sensation in areas that have had surgery. Diminished (or complete loss of skin sensation) may not totally resolve. Changes in sensation may affect sexual response or the ability to breast feed a baby.

    Skin Contour Irregularities- Contour and shape irregularities may occur. Visible and palpable wrinkling of skin may occur. Residual skin irregularities at the ends of the incisions or “dog ears” are always a possibility when there is excessive redundant skin. This may improve with time, or it can be surgically corrected.

Major Wound Separation- Wounds may separate after surgery. Should this occur, additional treatment

    including surgery may be necessary.

    Sutures- Most surgical techniques use deep sutures. You may notice these sutures after your surgery. Sutures may spontaneously poke through the skin, become visible or produce irritation that requires suture removal.

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    INFORMED CONSENT ALLODERM? REGENERATIVE TISSUE MATRIX

    Skin Discoloration / Swelling- Some bruising and swelling normally occur. The skin in or near the surgical site can appear either lighter or darker than surrounding skin. Although uncommon, swelling and skin discoloration may persist for long periods of time and, in rare situations, may be permanent.

    Skin Sensitivity- Itching, tenderness, or exaggerated responses to hot or cold temperatures may occur after surgery. Usually this resolves during healing, but in rare situations it may be chronic.

    Scarring- All surgery leaves scars, some more visible than others. Although good wound healing after a surgical procedure is expected, abnormal scars may occur within the skin and deeper tissues. Scars may be unattractive and of different color than the surrounding skin tone. Scar appearance may also vary within the same scar. Scars may be asymmetrical (appear different on the right and left side of the body). There is the possibility of visible marks in the skin from sutures. In some cases scars may require surgical revision or treatment.

    Damage to Deeper Structures- There is the potential for injury to deeper structures including, nerves, blood vessels, muscles, and lungs (pneumothorax) during any surgical procedure. The potential for this to occur varies according to the type of procedure being performed. Injury to deeper structures may be temporary or permanent.

    Firmness- Excessive firmness can occur after surgery due to internal scarring. The occurrence of this is not predictable. Additional treatment including surgery may be necessary.

    Delayed Healing- Wound disruption or delayed wound healing is possible. Some areas of the skin may not heal normally and may take a long time to heal. Areas of skin may die. This may require frequent dressing changes or further surgery to remove the non-healed tissue. Individuals who have decreased blood supply to tissue from past surgery or radiation therapy may be at increased risk for wound healing and poor surgical outcome. Smokers have a greater risk of skin loss and wound healing complications.

    Fat Necrosis- Fatty tissue found deep in the skin might die. This may produce areas of firmness within the skin. Additional surgery to remove areas of fat necrosis may be necessary. There is the possibility of contour irregularities in the skin that may result from fat necrosis.

    Asymmetry- Symmetrical body appearance may not result after surgery. Factors such as skin tone, fatty deposits, skeletal prominence, and muscle tone may contribute to normal asymmetry in body features. Most patients have differences between the right and left side of their body before any surgery is performed. Additional surgery may be necessary to attempt to improve asymmetry.

    Allergic Reactions- In rare cases, local allergies to tape, suture material and glues, blood products, topical preparations or injected agents have been reported. Serious systemic reactions including shock (anaphylaxis) may occur in response to drugs used during surgery and prescription medicines. Allergic reactions may require additional treatment.

Cardiac and Pulmonary Complications- Pulmonary complications may occur secondarily to both blood

    clots (pulmonary emboli), fat deposits (fat emboli) or partial collapse of the lungs after general anesthesia. Pulmonary emboli can be life-threatening or fatal in some circumstances. Inactivity and other conditions may increase the incidence of blood clots traveling to the lungs causing a major blood clot that may result in death. It is important to discuss with your physician any past history of swelling in your legs or blood clots that may contribute to this condition. Cardiac complications are a risk with any surgery and anesthesia, even in patients without symptoms. If you experience shortness of breath, chest pain, or unusual heart beats, seek medical attention immediately. Should any of these complications occur, you may require hospitalization and additional treatment.

    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.

    Seroma- Infrequently, fluid may accumulate between the skin and the underlying tissues following surgery, trauma or vigorous exercise. Should this problem occur, it may require additional procedures for drainage of

    Page 3 of 6 Patient Initials 5-01-05 version ??2005 American Society of Plastic Surgeons.

    INFORMED CONSENT ALLODERM? REGENERATIVE TISSUE MATRIX

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