Mentor Adjunct Study Informed Consent: Informed Consent for Patients in the Adjunct Study
The information below is taken from a copy of the Mentor Adjunct Study Informed Consent. New participants are NOT being added to this study. Enrollment for all silicone breast implant adjunct studies was closed in 2006 when the FDA approved silicone breast implants.
1. PURPOSE AND BACKGROUND OF THE STUDY
You are being asked to participate in the Mentor Silicone Gel-Filled Mammary Prosthesis Clinical Study. This Informed Consent gives you information about your breast implant procedure and your participation in this study and verifies that you have received it.
To be eligible for participation in this clinical study, you must complete a basic screening by your surgeon, be a candidate for breast reconstruction in which saline-filled implants are not suitable, and must not have specific connective tissue disorders. In addition, you must sign this document indicating that you have been provided with the required information. You should ask your surgeon to clarify any terms which you do not understand. Additionally, your surgeon must provide you with a copy of this document.
Breast implants have been used in nearly two million women since the early 1960’s. There are known risks and potential complications from having breast implants. Since 1992, the Food and Drug Administration (FDA) has allowed limited silicone gel implants for clinical studies of breast reconstruction and mastectomy for cancer, correction of deformities, or replacement of damaged implants. The FDA has not formally approved these gel-filled implants are safe and effective because additional scientific evidence needs to be collected. Your participation will help answer the remaining questions.
2. DEVICE DESCRIPTION
The manufacturer of the implants you and your doctor have chosen is Mentor. You may receive one of two different types of silicone gel-filled implants. One implant contains silicone-gel and saline solution and the second contains only silicone. Your plastic surgeon will discuss the various types of implants with you and explain why a particular device may be best suited for you.
3. SECOND OPINIONS
If any problems occur during the study, you may be asked or with to obtain second opinions. You have the right to consult a physician of your choice.
4. STUDY PROCEDURES
You will talk about your procedure and participation in this study with your surgeon in advance and you should take sufficient time to think about participating. You should check with your insurance company prior to the operation, as the surgery may affect your insurance coverage. For patients who have undergone breast implantation either as a cosmetic or reconstructive procedure, health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. Check with your insurance company regarding insurance coverage.
If you agree to be in this study, you will first have to be examined to determine if you are a good candidate, and if you are eligible. This screening may involve referral to other physicians. Follow-up visits to other physicians may also be required.
Description of Operation: The operation you will have will be performed by a surgeon using accepted standards of practice. The operation may be performed in the physician’s office, or in a hospital operating room or in an outpatient surgical center. Hospitalization may or may not be required. Your surgeon will explain the particular type of implant that will be used, how and where it will be placed, and the type of anesthesia to be used. He/she will also give you an overall description of the operation. This may not be a one time operation. Further procedures involving expansion/inflation of your implant or management of complications may be needed.
Surgical Consent: In addition to this Consent Form, you may have signed, or will be asked to sign a surgical consent form which addresses specific risks of the surgical procedure and risks of anesthesia.
Follow-up Visits / Extra Appointments with your Surgeon: In addition to normal visits/appointments with your surgeon (i.e., 1-2 weeks, 1 month, 6 months), additional appointments are required as a part of the research. Your participation in the research will be for 5 years. The study schedule requires follow-up visits 12 months, 36 months, and 60 months after your surgery. Each visit will take 30-60 minutes. You are making a commitment to continue in the study for the duration. It is important that you come back for all postoperative (follow-up) visits. If you move within 5 years, arrangements will be made with your surgeon for follow up with someone in your area.
5. IMPLANT REGISTRY
You will additionally be asked to enroll in a breast implant registry which will allow Mentor to notify you, if necessary, of important safety information about your silicone gel-filled breast implant(s). Every effort will be made to keep the information in the registry confidential and will only be provided to the FDA, upon their request. However, under certain circumstances, Congress has the right to get clinical data from the FDA or a court could order disclosure of certain information that could include your clinical study records.
6. BENEFITS OF BREAST IMPLANTS
Women with breast cancer have reported that breast reconstruction with mammary implants has aided in their recovery from breast cancer and has reduced emotional stress by helping to return their body to a more natural appearance.
You may benefit other women by providing information about possible health problems associated with breast implants and to help demonstrate the safety of the device. There are no direct additional benefits to you beyond receiving this implant.
7. RISKS AND DISCOMFORTS OF THE OPERATION
Breast surgery requires an incision. As with any surgical procedure, there are risks such as:
Infection – (severe infection on rare occasions results in Toxic Shock Syndrome or TSS)
An infection can result from any surgery and produce swelling, tenderness, pain and fever. Almost all infections appear within a few days of the operation but may appear at any time after your surgery. If you get a serious infection, which doesn’t go away with antibiotics, your implant may have to be removed.
Hematoma Formation – a collection of blood in the surgical area.
Seroma – (fluid accumulation around the implant which may or may not require removal). Your body will absorb both areas of fluid accumulation (seroma) and small hematomas, but large ones may have to be drained surgically to permit proper healing. Surgical techniques, under most circumstances, can minimize though not eliminate them.
Scarring – Any incision in the skin will leave a scar that is permanent. While your surgeon will use plastic surgical techniques to make this as inconspicuous as possible, some patients have a skin quality that results in more conspicuous scars no matter how the incision is repaired.
Anesthetics – there are risks from anesthetics as well.
8. RISKS AND DISCOMFORTS OF BREAST IMPLANTS
Breast Implants have certain specific risks and complications which may include:
The normal healing scar membrane that forms around the implant can, in some women, tighten and squeeze the implant. This can cause the implant to feel firm. This firmness can range from slight to quite hard and the firmest ones can cause varying degrees of discomfort or pain. In addition to the firmness, capsular contracture can result in a misshapen breast, visible surface wrinkling and/or displacement of the implant. Detection of breast cancer by mammography may also be more difficult.
If you wish to have this contracture softened, the scar tissue can be released or removed by making an incision into the breast during an operation called an Open Capsulotomy.
Your surgeon may recommend a technique called a closed capsulotomy in which he/she will apply forceful external pressure to the breasts to “break up” the scar tissue. Mentor does not recommend this technique because it could result in several complications such as breakage of the implant, bleeding, displacement of the implant resulting in asymmetry or distortion.
Your surgeon will explain the possible complications, as well as help you determine the best method for correcting capsular contracture.
Calcification of the capsule surrounding the implant can also occur. This can contribute to the hardening of the tissue and may be painful. Sometimes, it may be necessary to remove the implant and/or the calcified capsule.
Deflation / Rupture / Leakage
Breast implants are not lifetime devices and cannot be expected to last forever. Some implants deflate or rupture in the first few months after being implanted and some deflate after several years; others are intact 10 or more years after the surgery.
Silicone Gel-Filled Breast Implants – When silicone gel-filled implants rupture, some women may notice decreased breast size, nodules (hard knots), uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Other women may unknowingly experience a rupture without any symptoms (i.e., “silent rupture”). Magnetic resonance imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating patients with suspected rupture or leakage of their silicone gel-filled implant.
Silicone gel which escapes the fibrotic capsule surrounding the implant may migrate away from the breast. The free silicone may cause lumps called granulomas to form in the breast or other tissues where the silicone has migrated, such as the chest wall, armpit, arm, or abdomen.
Plastic surgeons usually recommend removal of the implant if it has ruptured, even if the silicone is still enclosed within the scar tissue capsule, because the silicone gel may eventually leak into surrounding tissues. If you are considering the removal of an implant ant the implantation of another one, be sure to discuss the benefits and risks your doctor.
FDA completed a retrospective study on rupture of silicone gel-filled breast implants. This study was performed in Birmingham, Alabama and included women who had their first breast implant before 1988. Women with silicone gel-filled breast implants had a MRI examination of their breasts to determine the status of their current breast implants.
The 344 women who received a MRI examination had a total of 687 implants. Of the 687 implants in the study, at least two of the three study radiologists agreed that 378 implants were ruptured (55%). This means that 69% of the 344 women had at least one ruptured implant. Of the 344 women, 73 (21%) had extracapsular silicone gel in one or both breasts. Factors that were associated with the rupture included increasing age of the implant, the implant manufacturer, and submuscular rather than subglandular location of the implant.
Robinson et al. studied 300 women who had their implants for 1 to 25 years and had them removed for a variety of reasons. Visible signs of rupture in 51% of the women studied were found. Severe silicone leakage (silicone outside the implant without visible tears or holes) was seen in another 20%. Robinson et al. also noted that the chance of rupture increases as the implant ages.
Other studies indicate that silicone may escape the capsule in 11-23% of rupture cases.
Silicone gel is made up of a sponge like mesh filled with silicone in oil form. This oil is used in many medical products such as syringes, pills, and anti-gas medications such as Mylanta. It is known that some very small amounts of the oil part of the gel “bleeds” through the implant’s covering or envelope. Although most of this stays in the implant pocket or is trapped in the surrounding scar, minute amounts of this silicone could possibly travel (migrate) to different parts of the body.
Silicone oil has not been demonstrated to cause cancer or other illness.
Changes in Nipple and Breast Sensation / Breast Pain
Any surgery on the breast, including a biopsy or breast implant surgery, can result in the breast and/or nipple being oversensitive or undersensitive on one or both sides. This change can vary in degree and may be temporary or permanent. It may affect comfort while nursing or sexual response.
Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some breast and/or chest pain postoperatively. While this pain normally subsides in most women as they heal after surgery, it can become a chronic problem in other women.
Chronic pain can be associated with hematomas, migration, infection, and implants that are too large, or capsular contracture. Sudden severe pain may be associated with implant rupture.
Interference with Mammography in Detection of Cancer
An implant may interfere with the detection of early breast cancer because it may “hide” suspicious lesions in the breast during an x-ray examination. It is especially important for women who are at high risk of developing breast cancer to consider this before having implants. The earlier cancer is detected, the better a chance for a cure.
Regular self-examination is very important for all women but especially if you have implants. You are urged to contact the American Cancer Society for literature and instructions on the early detection of cancer.
Since the breast is compressed during mammography, it is possible, but rare, for an implant to rupture. These problems can be reduced, but not eliminated, by asking if the personnel at the facility are experienced in performing mammography on women with implants.
Before the mammography exam, you should tell the technologist that you have implants. The technologist should take special care when compressing the breast to avoid rupture. Also, an experienced technologist should know how to push the implant away from the breast tissue to get the best possible views of the tissue. Even when this special technique is used, some breast tissue may be missed in the x-ray. More x-ray views are necessary with these special techniques; therefore, women with breast implants will receive more radiation. However, the benefit of the mammogram in finding cancer outweighs the risk of the additional x-rays.
Small spots of calcium in the breast are often found in any breast and can be seen on x-rays (mammography). These deposits may not occur in breasts with implants and may not appear for years after the implant surgery. They are benign (non-cancerous) and cause no problems but must be differentiated from the calcium that is often seen in breast cancers. An expert radiologist can usually tell a benign (non-cancerous) calcium spot from a malignant one but occasionally a biopsy may be necessary to make this distinction. Some patients may develop a thin layer of calcium in the scar capsule that surrounds the implant. This is almost always associated with capsular contracture but otherwise causes no known problem.
Delayed Wound Healing
In some cases, the incision site fails to heal normally.
Unstable or compromised tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin.
Necrosis is the formation of dead tissue around the implant. This may prevent wound healing and require surgical correction and/or implant removal. Permanent scar deformity may occur following necrosis. Factors associated with increased necrosis include infection, use of steroids in the surgical pocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy.
Breast Tissue Atrophy / Chest Wall Deformity
The pressure of the breast implant may cause the breast tissue to thin and shrink. This can occur while implants are still in place or following implant removal without replacement.
Dissatisfaction with Cosmetic Results
You may not be satisfied with the appearance of your breasts after implants. The surgeon has only limited control over the final shape which is determined by how your chest, your breast, and the implant all fit together. Incorrect implant size, excessive scarring, and misplacement of implants may interfere with satisfactory appearance. Asymmetry (unequal breast size or shape) may not be totally corrected even by different sized implants. The implanted breast may sag or droop (ptosis) over time, much like a natural breast.
In addition, breast implants will not prevent your breasts from sagging after pregnancy. Very rarely the implant may change position or break through the skin, particularly if you have very thin breast tissue covering it. You may be able to feel or see wrinkles in the implant through your skin.
These are non-cancerous lumps that can form when certain body cells surround foreign material, such as silicone. Like any lump, it should be further evaluated to distinguish it from a lump that might be cancerous and require biopsy.
Whether you are undergoing augmentation or reconstruction, you should understand that there is a high chance that you will need to have additional surgery at some point to replace or remove the implant. Also, problems such as rupture, capsular contracture, infection, shifting, and calcium deposits can require removal of the implants. Many women decide to have the implants replaced, but some women do not. Those who do may have cosmetically unacceptable dimpling and/or puckering of the breast following removal of the implant.
9. UNKNOWN RISKS
The long-term biological effects of silicone compounds in women have received a great deal of attention over the last 25 years. Both rupture and gel bleed may result in silicone going to other parts of the body.
Concerns have included connective tissue disease, immunological and neurological disorders, and the risk of cancer.
Connective Tissue Disorders
There have been reports describing an association between certain silicone-based products and certain connective tissue disorders. These are a group of disorders in which the body reacts to its own tissue as though it was a foreign material. These disorders can cause long-term, serious, disabling health problems. Symptoms may include pain and swelling of joints, tightness, redness or swelling of the skin, swollen glands or lymph nodes, unusual and unexplained fatigue, swelling of the hands and feet, and unusual hair loss. Generally, people who have these relatively rare connective tissue disorders experience a combination of these and other symptoms.
Some cases of these disorders have been reported in women with breast implants. Some of these women have reported a reduction in symptoms after their implants were removed.
There have been some reports of patients experiencing neurological symptoms at variable times after breast implant surgery. Some of the complaints have involved difficulties with vision, sensation, muscle strength, walking, and balance.
There is presently no established scientific evidence that links either silicone gel-filled or saline-filled breast implants with cancer. However, the possibility cannot be ruled out.
Preliminary animal studies and a study in humans show no evidence that birth defects are caused by silicone implants. However, to rule out that possibility for humans, further scientific studies are necessary to show whether or not breast implants are associated with birth defects.
Many women with breast implants have nursed their babies successfully. Any breast surgery, such as breast biopsy or partial mastectomy, that removes a great deal of breast tissue, or even breast implant surgery, could theoretically interfere with your ability to nurse your baby or the amount of milk available.
In recent years there has been some question as to whether small amounts of silicone that “bleeds” from gel-filled breast implants can find its way into breast milk, and if this were to occur, could that affect the child. If you are considering breast-feeding, you are urged to check with your doctor or the FDA’s Breast Implant Information line at (800) MENTOR8 for the most current information. The American Academy of Pediatrics has stated that “there is no reason why a woman with implants should refrain from nursing.”
10. ALTERNATIVE PROCEDURES TO PARTICIPATION IN THIS STUDY
You may choose not to participate in this study. There are several alternative procedures to breast reconstruction with silicone gel-filled breast implants. These include having nothing done, or wearing an external prosthesis inside your bra. Breasts can be made my transferring fatty tissues from other parts of the body such as the stomach, buttock or back (flap procedure). For many women, saline-filled breast implants are also an alternative.
You may also choose to have your silicone gel breast implant procedure using another physician who is participating in a study using another brand of implant. If you choose to not participate in the study, you may not be provided with silicone gel implants by the manufacturer. Your surgeon should discuss these alternatives with you.
Your doctor will discuss these and other procedures and their relative risks and benefits.
11. IMPORTANT FACTORS TO CONSIDER WHEN DECIDING TO HAVE GEL-FILLED IMPLANTS
Be aware that breast implantation may not be a one time surgery. You are likely to need additional surgery and doctor visits over the course of your life. You are likely to need additional surgery and doctor visits over the course of your life.
Many of the changes to your breast following implantation are irreversible (cannot be undone). If you later choose to have your implant(s) removed, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast. Breast implants may affect your ability to produce milk for breastfeeding. Also, breast implants will not prevent your breasts from sagging after pregnancy.
With breast implants, routine screening mammography will be more difficult, and you will need to have additional views, which means more time and radiation.
Your health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. You should check with your insurance company regarding coverage issues.
Reconstruction – Most insurance covers the first breast reconstruction operation. Insurance coverage for re-operation procedures or additional doctor’s visits following reconstruction may not be covered, depending on the policy.
12. COMPENSATION FOR INJURY
Compensation for physical injuries, complications or medical treatment from your participation in this study is not available from Mentor other than outlined in the attached Mentor warranty. If your complication is related to rupture, you will be reimbursed under the warranty policy. If a problem occurs, medical treatment will continue to be available. Your doctor will let you know what to do if you experience any complications while you are in this study.
Your confidentiality will be protected as much as possible throughout this study. Records generated during this study which identify you by name will be maintained as confidential, with the exception that those records, as well as your medical records, may be reviewed by authorized representatives from your doctor’s office and from Mentor. In addition, authorized representatives from the U.S. Food and Drug Administration may inspect the records. Results of data collected will be reported as numbers only, no names. Under certain circumstainces, Congress or a court order could obtain your clinical records. While every effort will be taken to keep this information confidential, under these special circumstances, this could mean public disclosure of your surgery and loss of your privacy.
14. LEGAL RISK AND ANALYSIS OF REMOVED IMPLANT
If your implant needs to be removed, Mentor requests the implant be returned to Product Evaluation to be analyzed. This could have implications in any legal action involving your implant. Mentor will ask your permission to analyze it, a process that may alter or destroy it. You will be contacted first through your doctor and asked whether you wish to give permission for such an evaluation. Results of the analysis will be made available to you, your doctor and/or the FDA upon request. Mentor and the FDA believe there is scientific benefit to testing an explanted implant.
During the course of this study, you will be informed by your physician regarding any new information about Mentor brast implants which may become known during the study. You also have the right to ask questions and have them answered. For questions about your procedure, you should contact your plastic surgeon.
For questions or complaints regarding your participation in the study and your rights as a research subject, please contact the local, national, or non-local independet reviewer of the research listed below which your physician will give you.
16. VOLUNTARY PARTICIPATION AND WITHDRAWAL FROM STUDY
Your participation in this Study is voluntary and your decision not to participate will not result in loss of benefits to which you are otherwise entitled; however, you will not receive Mentor silicone gel-filled implants without being in this Study. You may drop out at any time and you will still receive all necessary medical care.
I was provided this consent form and met with my surgeon. All my questions have been answered to my satisfaction and I have been provided a copy of this form.