The following information is the Informed Consent that patients received when they were entered into the McGhan Style 410 Cohesive Silicone Breast Implant Study for silicone breast implants. As you can see, women are much more informed regarding the risks and benefits of breast implants. The breast implant study information provided here is very thorough, and informative.
Your surgeon and McGhan Medical Corporation (McGhan Medical), the manufacturer of silicone-filled breast implants, are inviting you to participate in the McGhan Medical Corporation Style 410 Silicone-Filled Breast Implant Clinical Study. This Patient Informed Consent gives you the information about your participation in this study. Please read this information carefully and ask your plastic surgeon for clarification on medical terms or any other issues or concerns you may have before signing this form. Your signature verifies that you have been given an opportunity to read all of the information in the consent and that you have received a copy of this form.
McGhan Medical Style 410 Silicone-Filled Breast Implants will be used in your surgery. To receive these silicone-filled breast implants and participate in the McGhan Medical Corporation Style 410 Silicone-Filled Breast Implant clinical Study, you must:
- Be a female 18 years of age or older
- Have a condition appropriate for breast augmentation, reconstruction, or revision
- Have adequate tissue available to cover the implant(s)
- Be willing to sign the Informed Consent document which gives you information about your breast implants and confirms your commitment to follow study requirements and acceptance of the potential risks involved.
You will also be asked to have a magnetic resonance imaging procedure (MRI) performed serially at 1, 3, 5, 7, and 9 years post-implantation and immediately prior to explantation.
A. Purpose and Background
The Food and Drug Administration (FDA) has issued a guidance document requiring that clinical studies be conducted to establish the safety and efficacy of silicone-filled breast implants ("Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses", October 5, 1999. The McGhan Medical Style 410 Silicone-Filled Breast Implant is an experimental device that is available to patients who participate in this clinical study. This study is designed to collect 10 year data on the safety and effectiveness of McGhan Medical Style 410 Silicone-Filled Breast Implants. A total of 940 patients will be enrolled into the study (approximately 500 augmentation patients, 200 reconstruction patients, and 200 revision patients). A subset of patients participating in this study will undergo serial MRI screenings throughout the duration of the study. The purpose of these MRI's is to determine the occurrence of asymptomatic or silent rupture, that is, implant rupture that exists with no noticeable symptoms to the patient.
B. Device Description
The Style 410 implant is constructed of an outer silicone elastomer envelope, featuring a textured surface, with a cohesive gel fill and shaped design.
C. Procedures
1. You will talk about your procedure and participation in this study with your surgeon in advance and you should take sufficient time to consider your decision.
2. If you agree to participate in this study, you will first have to be examined to determine if you are a good candidate and if you are eligible.
3. Description of Operation: The operation will be performed by a surgeon using accepted standards of practice. The operation may be performed in the physician's office, 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 management of complications may be needed.
4. Surgical Consent: In addition to this Informed Consent, you may be asked to sign a surgical consent form which addresses specific risks of the surgical procedure and risks of anesthesia.
5. Additional Follow-Up Visits / Extra Appointments with your Surgeon: In addition to normal post-operative appointments with your surgeon, there will be additional appointments which are required as part of the research. Your participation in the research will be for 10 years. The study schedule requires follow-up visits at 0-4 weeks, 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 years after your surgery. each visit will take about 30-60 minutes. If you have all of your study devices removed without replacement (either with a study or a non-study device) you will continue to be followed via telephone according to the same study schedule in order to obtain data on local adverse events. If you subsequently have a replacement with a study device, you will resume follow-up via an office visit. You are making a commitment to continue in the study for a full ten years and to complete all of the required follow-up visits within the time frame indicated. It is extremely important that you adhere to this follow-up schedule. If you move within the 10 years, arrangements will be made with your surgeon for follow-up with someone in your area. Refer to the incentive payment section for specific target periods in which each visit should be scheduled.
6. Quality of Life Questionnaire: All augmentation and reconstruction study participants are required to fill out a confidential quality of life questionnaire (Form QL). This questionnaire must be completed during your office visit. This questionnaire will be completed prior to primary breast implant surgery and at the 1 and 2 year follow up intervals. These forms have been developed to assess why women choose to have implant surgery and how having implants affects their quality of life and self-perception. This questionnaire is confidential and at no point is it evaluated on an individual basis, nor is it intended for use as a screening or counseling tool. This form should be completed during your scheduled office visit. Patients who are being followed by telephone due to explant of all devices will complete this questionnaire via mail. You are advised o discuss with your surgeon any questions or concerns that you may have with this questionnaire.
7. Connective Tissue Disease Screening: The relationship, if any, between implants and the development of connective tissue disease (CTD) has not been established. The FDA has recommended that manufacturers of breast implants obtain information on patients' signs, symptoms and diagnoses of connective tissue disease. All study participants are required to fill out an Activities and Lifestyle Index (Form A&L) at periodic intervals. This form has been designed to follow signs and symptoms of connective tissue disease. You will complete the Activities and Lifestyle Index before primary implant surgery and at the 1, 2, 4, 6, 8, and 10 year follow-up visits. This form should be completed during your scheduled office visit. Your surgeon will review the completed questionnaire with you. He/she will let you know whether or not you should consider visiting a rheumatologist for further evaluation.
In addition, if you indicate that you have a connective tissue disease, the doctor who diagnosed your condition or your attending doctor will need to be contacted to provide confirmation of the diagnosis. Your surgeon will contact your diagnosing/attending physician for information regarding any connective tissue disease you may have.
8. Photographs: Photographs of your breast/chest area will be taken by your surgeon or his/her staff prior to surgery and one year after surgery. These photos will remain confidential and may be viewed by your surgeon, office staff, and McGhan Medical personnel or representatives of McGhan Medical. The FDA also may have access to these photos, as with other study records.
9. Magnetic Resonance Imaging (MRI): You will be asked to undergo a magnetic resonance imaging procedure (MRI) serially at 1, 3, 5, 7, and 9 years post-implantation to evaluate the occurrence of asymptomatic rupture. If you have all of your original study implants removed (with or without replacement), you are no longer eligible to participate in the serial MRI portion of this study.
Additionally, if you are scheduled for explantation of your study implants for any reason, you will be asked to obtain an MRI immediately prior to explant surgery. The purpose of the pre-explant MRI is to determine the effectiveness of MRI for detecting possible implant rupture.
At any time of study enrollment, you will be evaluated for eligibility and willingness to undergo MRI. You will be excluded from the MRI portion of the study if you have any metal devices or metal implanted or a past history of severe claustrophobia. Please inform your surgeon if you may be ineligible to participate in the MRI portion of the study. He/she will let you know if you are eligible.
MRI is a medical diagnostic technique that has been used to determine if an implant has ruptured. However, it is not a routine procedure for determining whether a breast implant is ruptured and may not always be able to detect a rupture. MRI uses no x-rays and the magnetic fields MRI uses are not known to be harmful; that is, though the use of magnetic fields is not thought to be harmful, short- and long-term side effects are unknown.
MRI involves a painless scan. For the MRI scan, due to the magnetic field, you will be required to remove all metal objects (e.g., jewelry, eye glasses) prior to scanning. A surface coil will be attached to the breast/chest area. Scanning involves being placed on a scanning tunnel, open at both ends. You will be required to stay still during the scan. Total scanning usually ranges from 30-90 minutes. If you are uncomfortable being in a small, enclosed place, a physician may give you a sedative. In such cases, someone should attend the MRI with you to assist you.
Please discuss any questions about MRI with your surgeon. You will be required to attend an MRI clinic in which the appropriate MRI technique will be utilized. At the MRI facility where the MRI will be performed, you should also be informed about MRI and sign an informed consent. The local MRI facility will also evaluate you to determine if you are eligible for MRI.
Your surgeon's office will assist you in scheduling the MRI.
In order to allow for an unbiased evaluation of your MRI, please do not indicate to the MRI staff performing your MRI screening whether you or your surgeon suspect that your implant(s) may be ruptured. Your results from the local MRI facility will be forwarded to your surgeon. Additionally, the MRI images on disk, without the report, will be sent to a second MRI reviewer (MRI Central Reviewer), who will review all MRI results obtained in the study. The MRI Central Reviewer will perform an independent evaluation of your MRI; that is, the results from the local facility will not be known to the MRI Central Reviewer. The MRI Central Reviewer will provide a detailed report to your surgeon and McGhan Medical. Your surgeon will review the findings of both the local facility and Central Reviewer reports and consult with you as to the appropriate treatment, if necessary.
10. Removed Implants: If during the course of the study both of your implants (or one if implanted on one side only) are removed and replaced with a non-study device, you will be discontinued from this study. If you have your study devices removed without replacement, either by a study or non-study device (i.e., you no longer have any breast implants), you will continue to be followed via telephone in order to obtain data on local adverse events.
11. Analysis of Removed Implants: If there is a problem resulting in a medical need to remove your breast implants, McGhan Medical and the FDA believe there is a scientific benefit to testing an explanted implant Should McGhan Medical perform an evaluation of the removed implants, the testing could alter or destroy the implant.
12. Implant Identification: After your surgery, your surgeon will provide you with identification information regarding the type of implant you have. This information should be kept with your important papers for future reference.
13. Second Opinions: If any problems or complications occur, you may be asked for with to obtain a second opinion. You have the right to consult with a physician of your choice.
D. Benefits of Breast Implants
The major effect of breast implants is to enhance or restore the appearance of a woman's breasts. Breast implant surgery may benefit you by providing a successful breast reconstruction or augmentation. There may be psychological benefits to having breast reconstruction or augmentation with silicone-filled implants. Each individual woman has her own private sense of how she wishes to look and whether she wishes to go through surgery o achieve this appearance. Ongoing studies will help evaluate whether breast implants improve a woman's quality of life.
Participating in the study also may benefit other women in future by providing scientific information about breast implants.
E. Risks
1. Risks, Complications, and Discomforts of the Operation : Breast surgery requires an incision into the breast under anesthesia. As with any surgical procedure, there are risks, such as infection, delayed wound healing, hematoma formation, seroma, bleeding, and possible reactions from anesthesia. These complications are uncommon. Surgical risks may include but are not limited to:
a. Infection: 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 on rare occasions may appear at any time after your surgery. If you get a serious infection which does not go away with antibiotics, your implants may need to be removed.
b. Hematomas / Seromas: Hematoma is a collection of blood inside the body in and round where the incision is made. Seroma is an accumulation of fluid around the implant. Post-operative hematoma and seroma may contribute to infection and/or capsular contracture. Any post-operative evacuation of hematoma or seroma must be conducted with care to avoid damage to the imp ant.
c. Toxic Shock Syndrome (TSS): TSS is a rare but serious risk from any surgical procedure. Symptoms include, but are not limited to, sudden fever (102? or above), vomiting, diarrhea, fainting, dizziness, and/or sunburn-like rash. If TSS symptoms occur, seek medical attention immediately.
d. Delayed Wound Healing: Your physical condition and overall health at the time of your surgery can influence how you heal. Other factors that may interfere with the ability of a wound to heal correctly are chronic illness, smoking, and certain medications that affect tissue or blood. Any incision in the skin will leave a scar. Surgical techniques under most circumstances can minimize, though not eliminate, scarring.
e. Bleeding or Anesthesia Reactions: These complications are uncommon. Through screening before surgery by the surgeon and anesthesiologist greatly minimize these risk factors associated with surgery.
f. Iatrogenic Injury: Iatrogenic injury is an injury to you, or your implants, caused by your surgeon or by medical procedures performed on you. Any surgical procedure involves the potential for accidental injury to you or your breast implants. Any invasive surgical procedure involving general anesthesia also carries certain risk.
2. Risks, Complications, and Discomforts of the Breast Implants :
Breast implants have certain specific risks and complications which may include:
a. Capsular Contracture: Scar tissue, referred to as a capsule, typically forms around the implant. This is a natural response to having any foreign object implanted in the body. The scar tissue that forms around the implant can contract or tighten and squeeze the implant making it feel firm. This firmness can range from slight to hard and can cause varying degrees of discomfort or pain. Radiation therapy subsequent to breast implant surgery may increase the risk of capsular contracture.
The scar tissue can be released or removed altogether by a procedure called Capsulectomy.
Your surgeon may recommend a technique called Closed Capsulotomy in which he/she will apply forceful external pressure to the breasts to "break up" the scar tissue. This technique is not recommended by the manufacturer. However, your surgeon may feel this is the best method for correcting the firmness because, if it works, it is quick, simple, and avoids surgery, although it may be painful. If your surgeon uses this technique, several complications may occur, including bleeding and displacement of the implant which may result in asymmetry, distortion, and breakage of the implant.
Your surgeon should explain the possible complications as well as help you determine your choice for correcting capsular contracture.
b. Calcium Deposits: Any surgery or injury to the breast can produce small spots of calcium in the breast tissue which can e seen on X-rays (mammography). These deposits may not occur until years after 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 calcium spot from a malignant one but occasionally a biopsy may be necessary to be absolutely sure. 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 problem.
c. Rupture: 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 surgery.
When silicone gel-filled implants rupture, some women may notice a 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 leaking 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 and the implantation of another one, be sure to discuss the benefits and risks with 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. A summary of the findings of this study is also available on the FDA's website at:
http://www.fda.gov/cdrh/breastimplants/studies/biinterview.pdf
http://www.fda.gov/cdrh/breastimplants/studies/birupture.pdf
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.
d. Silicone diffusion: Some silicone may also diffuse or "bleed" through the shell of the implant into the fibrotic capsule surrounding the implant. See above for discussion of silicone gel which then escapes the fibrotic capsule.
e. Complications with healing: Some potential complications with healing are extrusion, skin erosion, and necrosis. Extrusion occurs when the implant(s) pushes through the incision site or skin. This is rare but can occur. Skin erosion is the destruction of tissue that can have either a physical cause (e.g., the implant) or an inflammatory cause (e.g., infection). Necrosis is tissue death which can be caused by a variety of reasons associated with your surgery or your physical condition such as insufficient blood supply, radiation, and trauma.
f. Revision Surgery: Your implant(s) is not a lifetime device. Revision surgery, consisting of removal and replacement of your implant(s), may be required at any time. Medical management of adverse reactions may include subsequent surgeries, and possibly, revision surgery. Revision surgery may also be indicated to achieve satisfaction with cosmetic results. Second opinion: If any problems or complications occur, you may wish to obtain a second opinion. You have the right to consult a physician of your choice. However, you will be financially responsible for any second opinion.
g. Breast Tissue Atrophy / Chest Wall Deformity: Removal of implant(s) without replacement may cause tissue atrophy. In the event of explantation (permanent implant removal), the tissue that originally surrounded the implant may over time shrink and diminish. It also has been reported in rare cases that the chest wall at the site of the implant may appear deformed upon explantation (removal of implant).
h. Changes in Nipple and Breast Sensation: Any surgery on the breast, including a biopsy or breast implant surgery, can result in increased or decreased sensation of the breast and/or the nipple. This change can vary in degree and may be temporary or permanent. It may affect sexual response or comfort while nursing.
i. Interference with Mammography: An implant can interfere with the detection of early breast cancer because it may "hide" suspicious lesions in the breast during an x-ray exam. It is especially important for women who are at high risk for developing breast cancer to consider this before having implants. The earlier cancer is detected, the better the chance for a cure. You should discus with your physician the potential risks and benefits of pre-operative and post-operative mammography as baselines for future reference.
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 making sure the mammography facility is accredited by the American College of Radiology (ACR) and asking if the personnel at the facility are experienced in performing mammography on women with implants. The telephone number for the American College of Radiology is 800-227-6440. The ACR will be able to give listings of accredited facilities by state. Please note the accreditation does not imply expertise in performing mammography on women with implants.
Before the mammography exam, you should tell the technologist that you have breast implants. The technologist should take special care when compressing the breast to avoid implant 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 X-ray. Also, women with implants are subject to additional radiation and higher costs because more x-ray views are needed.
The small amount of additional radiation should not deter you from having mammograms when needed. The risk of a missed cancer is far greater than the risk associated with a slight amount of extra x-ray exposure.
j. Cosmetic Complications: You may not be satisfied with the appearance of your breast implants. Incorrect implant size, inappropriate scar location or appearance, and misplacement of implants may interfere with a satisfactory appearance. Asymmetry (unequal breast size or shape) may occur. The implanted breast may sag or droop (ptosis) over time, much like a natural
