Device Access Education | MemoryGel™ Implant PAS | MemoryGel™ Implant Starter Kit | Labeling | Forms
Device Access Education | MemoryGel™ Implant PAS | MemoryGel™ Implant Starter Kit | Labeling | Forms
Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery.
Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of an original primary breast reconstruction surgery. (A separate patient brochure is available for and should be read for breast reconstruction.)
Avoiding Implant Damage During Surgery and Medical Treatment or Procedures: Iatrogenic events inadvertently induced by a physician or surgeon, or by medical treatment or procedures, may contribute to premature implant failure. Do not allow sharp instruments, such as scalpels or needles, to contact the device during the implantation or other surgical procedures. Patients should be instructed to inform other treating physicians to observe this warning. The technique for inserting a gel device is significantly different than for a saline implant. Ensure that excessive force is not applied to a very small area of the shell during insertion of the device through the incision. Instead, apply force over as large an area of the implant as possible when inserting it. Avoid pushing the device into place with one or two fingers in a localized area, as this may create an area of weakness on the shell. An incision should be of appropriate length to accommodate the style, size, and profile of the implant. The incision will be longer than the one typically made for a saline breast augmentation. This will reduce the potential for creating excessive stress to the implant during insertion. The mean incision sizes used in Mentor’s Core Study were as follows: Augmentation: 4.3 cm; Revision-Augmentation: 5.2 cm; Reconstruction: 6.9 cm; and Revision-Reconstruction: 6.5 cm. The anatomical limitations of periareolar and axillary incision sites may make insertion of the implant more difficult, increasing the risk of damage to the implant. Avoid creating wrinkles or folds in the device during the implantation or other procedures (e.g., revision surgery). A typical practice is to run your finger around the implant before closing to ensure the implant is lying flat and has no folds or wrinkles. Submuscular placement of the device makes the inspection for wrinkles or folds more difficult. Do not alter the implants or attempt to repair or insert a damaged implant. Use care in subsequent procedures such as open capsulotomy, breast pocket revision, hematoma/seroma aspiration, biopsy, and lumpectomy to avoid damage to the implant shell. Do not contact the implant with cautery devices. Do not immerse the implant in Betadine® solution. If Betadine is used in the pocket, ensure that it is rinsed thoroughly so no residual solution remains in the pocket. Do not use microwave diathermy in patients with breast implants, as it has been reported to cause tissue necrosis, skin erosion, and extrusion of the implant.
Safety and effectiveness have not been established in patients with the following: autoimmune diseases such as lupus and scleroderma; conditions that interfere with wound healing and blood clotting; a weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease); and reduced blood supply to breast tissue.
Device integrity – The device should be tested for patency and shell integrity immediately prior to use. This can be accomplished by gently manipulating the prosthesis with hand and fingers, while carefully examining for rupture or leakage sites.
Surgical technique – The implantation of silicone gel-filled breast implants involves a variety of surgical techniques. Therefore, the surgeon is advised to use the method which her/his own practice and discretion dictate to be best for the patient, consistent with this product insert data sheet. It is advisable to have more than one size breast implant in the operating room at the time of surgery to allow for flexibility in determining the appropriate size implant to be used. A backup implant should also be available.
Implant Selection -- Some of the important surgical and implant sizing variables that have been identified include the following: The implant should not be too small or too large in comparison to the patient’s chest wall dimensions, including base width measurements. A thorough discussion should be conducted with the patient, employing appropriate visual aids such as imaging, sizing implants, or other options to clarify their objectives and reduce the incidence of reoperation for size change. The following may cause implants to be more palpable: textured implants, larger implants, subglandular placement, and an insufficient amount of skin/tissue available to cover the implant. Available tissue must provide adequate coverage of the implant. A recent report indicates that larger sized implants (>350cc) may increase the risk of developing complications such as extrusion, hematoma, infection, palpable implant folds, and visible skin wrinkling requiring surgical intervention to correct these complications.
Incision Site Selection -- The periareolar site is typically more concealed, but it is associated with a higher likelihood of difficulties in successfully breast feeding as compared to other incision sites. A periareolar incision may result in changes in nipple sensation. The inframammary incision is generally less concealed than the periareolar, but it is associated with less breast feeding difficulty than the periareolar incision site. The axillary incision is less concealed than the periaeolar site.
Implant Placement Selection -- A well-defined, dry pocket of adequate size and symmetry must be created to allow the implant to be placed flat on a smooth surface. Submuscular placement may make surgery last longer, may make recovery longer, may be more painful, and may make it more difficult to perform some reoperation procedures than subglandular placement. The possible benefits of this placement are that it may result in less palpable implants, less likelihood of capsular contracture, and easier imaging of the breast for mammography. Also, submuscular placement may be preferable if the patient has thin or weakened breast tissue. Subglandular placement may make surgery and recovery shorter, may be less painful, and may be easier to access for reoperation than the submuscular placement. However, this placement may result in more palpable implants, greater likelihood of capsular contracture, and increased difficulty in imaging the breast with mammography.
Maintaining Hemostasis/ Avoiding Fluid Accumulation -Careful hemostasis is important to prevent postoperative hematoma formation. Should excessive bleeding persist, implantation of the device should be delayed until bleeding is controlled. Postoperative evacuation of hematoma or seroma must be conducted with care to avoid breast implant contamination, or damage from sharp instruments, retraction, or needles.
Recording Procedure -- Each breast implant is supplied with two Patient Record Labels showing the catalog number and lot number for that device. Patient Record Labels are located on the internal product packaging attached to the label. To complete the Patient ID Card, adhere one Patient Record Label for each implant on the back of the Patient ID Card. The other label should be affixed to the patient’s chart. The implanted position (left or right side) should be indicated on the label. If a Patient Record Label is unavailable, the lot number, catalog number, and description of the device may be copied by hand from the device label. The patient should be provided with the Patient ID Card for personal reference.
Postoperative Care -- You should advise your patient that she will likely feel tired and sore for several days following the operation, and that her breasts may remain swollen and sensitive to physical contact for a month or longer. You should also advise her that she may experience a feeling of tightness in the breast area as her skin adjusts to her new breast size. For at least a couple of weeks, the patient should avoid any strenuous activities that could raise her pulse and blood pressure. She should be able to return to work within a few days. Breast massage exercises may also be recommended as appropriate.
Breast implant surgery should not be performed in: women with existing malignant or pre-malignant cancer of their breast who have not received adequate treatment for those conditions; women with active infection anywhere in their body; and women who are currently pregnant or nursing. The following surgical practices are contraindicated and should not be performed: an implant may not be explanted and re-used, nor may it be resterilized; physicians should not place more than one implant in each breast; the implant should not be altered; capsular contracture should not be treated by forceful external compression (capsular contracture), which will likely result in implant damage, rupture, folds, and/or hematoma; and the implant should not be placed using the umbilical approach.
Mental Health and Elective Surgery – It is important that all patients seeking to undergo elective surgery have realistic expectations that focus on improvement rather than perfection. Complications or less than satisfactory results are sometimes unavoidable, may require additional surgery, and are often stressful. Request that your patient openly discuss with you, prior to surgery, any history that she may have of significant emotional depression or mental health disorders.
Rupture – If there is a clinical suspicion of rupture, an MRI examination is recommended. If rupture is confirmed by any means, explantation is recommended. If a rupture is identified through an MRI scan, patients should be advised to have their ruptured implant removed. To screen for silent ruptures, MRI scans are recommended to evaluate implant integrity at 3 years post-operatively and every 2 years thereafter. Diagnostic procedures will add to the cost of having breast implants, and patients should be told that these costs may exceed the cost of their initial surgery over their lifetime.
Reoperation – Additional surgeries to the patients’ breasts and/or implants will likely be required, either because of rupture, other complications, or unacceptable cosmetic outcomes. Patients should be advised that their risk of future complications increases with revision surgery as compared to primary augmentation or reconstruction surgery. There is a risk that implant shell integrity could be compromised inadvertently during reoperation surgery, potentially leading to product failure.
Explantation – Implants are not considered lifetime devices, and patients likely will undergo implant removal(s), with or without replacement, over the course of their life. When implants are explanted without replacement, changes to the patient’s breasts may be irreversible.
Long-Term Effects The long-term safety and effectiveness of Mentor implants continues has not been established. Mentor’s Core Study is ongoing and is not concluded. The Core Study will continue to evaluate the long term (i.e., 10 years) performance of these products. Unanswered questions remain regarding breast implants long term. Mentor will continue to further address other long-term issues postapproval.
Lactation – Breast implant surgery may interfere with the ability to successfully breast feed, either by reducing or eliminating milk production.
Infection – Signs of acute infection reported in association with breast implants include erythema, tenderness, fluid accumulation, pain, and fever. In rare instances, as with other invasive surgeries, Toxic Shock Syndrome (TSS) has been noted in women after breast implant surgery, and it is a life-threatening condition. Symptoms of TSS occur suddenly: a high fever (102°F, 38.8°C or higher), vomiting, diarrhea, a sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches and drops in blood pressure which may cause fainting. Patients should contact a physician immediately for diagnosis and treatment for any of these symptoms.
Smoking – Smoking may interfere with the healing process.
Cosmetic Dissatisfaction – Dissatisfaction with cosmetic results related to such things as scar deformity, hypertrophic scarring, asymmetry, displacement, incorrect size, unanticipated contour, and palpability may occur. Careful surgical planning and technique can minimize, but not preclude, the risk of such results. Preexisting asymmetry may not be entirely correctable by implant surgery. Physiological and behavioral differences among patients and variations in surgical techniques and medical treatments account for a wide variety of responses to silicone gel-filled breast implant surgery. Revision surgery may be indicated to maintain patient satisfaction, but carries additional considerations and risks.
Breast Examination Techniques – Patients should perform breast self-examinations monthly and be shown how to distinguish the implant from their breast tissue. The patient should not manipulate or squeeze the implant excessively. The patient should be told that the presence of lumps, persistent pain, swelling, hardening, or change in the implant shape may be signs of symptomatic rupture of the implant. If the patient has any of these signs, they should be told to report them, and possibly have an MRI evaluation to screen for rupture.
Follow-up Examinations – Patients should have follow-up physical examinations on an annual basis by a physician familiar with breast implants. The patient should be instructed that these annual visits should not replace having screening MRI to look for implant rupture or performing monthly examination of their breasts and implants.
Mammography – Patients should be instructed to inform their mammographers about the presence, type, and placement of their implants. Patients should request a diagnostic mammography, rather than a screening mammography. Breast implants may complicate the interpretation of mammographic images by obscuring underlying breast tissue and/or by compressing overlying tissue. Accredited mammography centers, technicians with experience in imaging patients with breast implants, and use of displacement techniques are needed to adequately visualize breast tissue in the implanted breast. The current recommendations for preoperative/screening mammograms are no different for women with breast implants than for those women without implants. Presurgical mammography with a mammogram following the procedure may be performed to establish a baseline for routine future mammography in augmentation patients.
Avoiding Damage During Treatment – Patients should inform other treating physicians of the presence of implants to minimize the risk of damage to the implants.
Radiation to the Breast – Mentor has not tested the in vivo effects of radiation therapy in patients who have breast implants. The literature suggests that radiation therapy may increase the likelihood of capsular contracture, necrosis, and extrusion. Insurance coverage – Patients should be advised that health insurance premiums may increase, insurance coverage may be dropped, and/or future coverage may be denied based on the presence of breast implants. Treatment of complications may not be covered as well. Patients should check with their insurance company regarding coverage issues before undergoing surgery.
The following is a list of potential complications that may occur with implant surgery. These include: rupture; capsular contracture; additional surgeries; implant removal; dissatisfaction with cosmetic results; pain; changes in nipple and breast sensation; infection; hematoma/seroma; breast feeding; calcium deposits in the tissue around the breast; extrusion; necrosis; delayed wound healing; breast tissue atrophy/chest wall deformity; and lymphadenopathy. Please refer to the full product insert data sheet for a discussion of complications.
There have been reports of other conditions in women with breast implants. Although no cause and effect relationship has been established between breast implants and these conditions, you should be aware of reports of connective tissue disease; rheumatological signs and symptoms; cancer (breast, brain, respiratory/lung, cervical/vulvar, other); suicide; and second generation effects. Please refer to the full Product Insert Data Sheet for a discussion of these other reported conditions.
You should advise your patient that she must read the patient brochure for either augmentation or reconstruction, as applicable. You must read the patient brochures in their entirety. The brochures are intended as the primary means to relate uniform risk and benefit information to assist your patient in making an informed decision about primary breast augmentation and revision-augmentation, or primary reconstruction and revision-reconstruction surgery (as applicable), but are not intended to replace consultation with you. The patient should be advised to wait at least 1-2 weeks after reviewing and considering this information, before deciding whether to have this surgery, unless an earlier surgery is deemed medically necessary. Both you and your patient will be required to sign the “Acknowledgement of Informed Decision” form prior to surgery. The form can be found on the last page of each brochure. The form, once signed, acknowledges the patient’s full understanding of the information provided in the brochure. The form should be retained in the patient’s permanent clinical record.