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«MENTOR MEMORYGEL™ SILICONE GEL-FILLED BREAST IMPLANTS 102872-001 -Rev. Cev A effective June 2006 102872 001 R Effective November 2006 CAUTION: ...»

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Product Insert

Data Sheet

MENTOR MEMORYGEL™ SILICONE GEL-FILLED BREAST IMPLANTS

102872-001 -Rev. Cev A effective June 2006

102872 001 R Effective November 2006

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a

physician.

INTRODUCTION - DIRECTIONS TO THE PHYSICIAN

The information supplied in this physician labeling document is intended to provide an

overview of essential information about Mentor’s MemoryGel Silicone Gel-Filled Breast Implants, including a device description, the indications for use, contraindications, warnings, precautions, important factors to discuss with a patient, adverse events, other reported conditions, a summary of clinical study results, returned devices, product evaluation, medical device reporting, and returned goods authorization.

Patient Counseling Information You should review this document and patient labeling prior to counseling the patient about Mentor’s MemoryGel Silicone Gel-Filled Breast Implants and breast implant surgery. MemoryGel implant labeling materials are part of physician training, a requirement described below in this Introduction. Please familiarize yourself with the content of this document and resolve any questions or concerns prior to proceeding with use of the device. As with any surgical procedure, breast implantation is NOT without risks. Breast implantation is an elective procedure, and the patient must be well counseled and understand the risk/benefit relationship.

Before making the decision to proceed with surgery, the surgeon or a designated patient counselor should instruct the patient to read Important Information for Augmentation/Reconstruction Patients About Mentor MemoryGel™ Silicone GelFilled Breast Implants (patient labeling) and discuss with the patient the warnings, contraindications, precautions, important factors to consider, complications, Mentor Core Study results, and all other aspects of the patient labeling. The physician should advise the patient of the potential complications and that medical management of serious complications may include additional surgery and explantation.

Informed Decision Each patient should receive Mentor’s Important Information for Augmentation/Reconstruction Patients About Mentor MemoryGel™ Silicone GelFilled Breast Implants during her initial visit/consultation, to allow her sufficient time to read and adequately understand the important information on the risks, follow-up recommendations, and benefits associated with silicone gel-filled breast implant surgery.

Allow the patient atleast 1-2 weeks after reviewing and considering this information before deciding whether to have primary breast augmentation surgery. In the case of a revision-augmentation and revision-reconstruction, it may be medically necessary to perform surgery sooner.

In order to document a successful informed decision process, the patient labeling includes an Acknowledgment of Informed Decision form at the end of the document, which is to be signed by both the patient and the surgeon and then retained in the patient’s file.

PHYSICIAN TRAINING - Completion of Mentor’s Device Access Education Course is required for all physicians in order to gain access to Mentor’s MemoryGel Silicone GelFilled Breast Implants. The Food and Drug Administration (FDA) will allow a 90-day transition period for all current Mentor Core Study and Adjunct Study investigators, after which these physicians/surgeons must also have completed the training program in order to have access to the Mentor product. Physician certification provides documentation of training in the use of these devices. Mentor has developed an online training and certification of participation process (The Device Access Education Course) that may be accessed via MemoryGel.com, or you may obtain a DVD of the training and certification material by contacting your Mentor sales representative.

DEVICE TRACKING - Silicone gel-filled breast implants are subject to Device Tracking by Federal regulation. Your compliance with this requirement is mandatory. This means that you will be required to report to Mentor the serial number of the device(s) you implant in a patient, the date of her surgery, her social security number, her personal contact information, and information relating to your practice. This information will be recorded on a Device Tracking Form supplied by Mentor with each silicone gel-filled breast implant.

Mentor strongly recommends that all patients receiving silicone gel-filled breast implants participate in Mentor’s device tracking program. This will help ensure that Mentor has a record of each patient’s contact information so that patients can be contacted in the event of a recall or other problems with the implants that they should be made aware of. If a patient declines to provide personal, identifying information, you must still provide all other non-patient specific information.

DEVICE DESCRIPTION

Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. The shell is filled with MemoryGel™, Mentor’s proprietary formulation of silicone gel. The shell is constructed of successive cross-linked layers of silicone elastomer, which give the prosthesis its elasticity and integrity. There are two styles of shell: smooth and textured.





Prior to receiving Mentor’s MemoryGel breast implants, a surgeon must complete a Device Access Education Course, which consists of 3 modules specific to these products and breast implant surgery.

The following lists the catalog numbers and styles of Mentor MemoryGel round implants:

350-7100BC/7800BC: Moderate Profile, smooth shell surface 354-1007/8007: Moderate Profile, textured shell surface 350-1001BC/8001BC: Moderate Plus Profile, smooth shell surface 354-1001/8001: Moderate Plus Profile, textured surface 350-1254BC/8004BC: High Profile, smooth shell surface 354-4125/4800: High Profile, textured surface The following diagrams illustrate the Moderate, Moderate Plus, and High Profiles.

Moderate Profile Moderate Plus Profile High Profile

INDICATIONS

Mentor MemoryGel Silicone Gel-Filled Breast Implants are indicated for females for the

following uses (procedures):

• Breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

• Breast Reconstruction. 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 results of a primary breast reconstruction surgery.

CONTRAINDICATIONS

Patient Groups in which the product is contraindicated:

• Women with active infection anywhere in their body.

• Women with existing cancer or pre-cancer who have not received adequate treatment for those conditions.

• Women who are currently pregnant or nursing.

WARNINGS

1. 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 range, mean, and mode of incision sizes

used in Mentor’s Core Study were as follows:

–  –  –

• 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 treat capsular contracture by closed capsulotomy or forceful external compression, which will likely result in implant damage, rupture, folds, and/or hematoma.

• 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. Re-positioning of the implant during subsequent procedures should be carefully evaluated by the medical team and care taken to avoid contamination of the implant. Use of excessive force during any subsequent procedure can contribute to localized weakening of the breast implant shell potentially leading to decreased device performance.

• 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 alter the implants or attempt to repair or insert a damaged implant.

• Do not re-use or resterilize any product that has been previously implanted. Breast implants are intended for single use only.

• Do not place more than one implant per breast pocket.

• Do not use the periumbilical approach to place the implant.

2. Microwave Diathermy Do not use microwave diathermy in patients with breast implants, as it has been reported to cause tissue necrosis, skin erosion, and implant extrusion.

PRECAUTIONS

1. Specific Populations

Safety and effectiveness has not been established in patients with:

• Autoimmune diseases (e.g., lupus and scleroderma).

• A compromised immune system (e.g., currently receiving immunosuppressive therapy).

• Patients with conditions or medications which interfere with wound healing ability (e.g., poorly controlled diabetes, or corticosteroid therapy) or blood clotting (such as concurrent coumadin therapy).

• Reduced blood supply to breast or overlying tissue.

• Patients undergoing radiation therapy.

• Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please advise the patient to discuss any history of mental health disorders with you prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

There may be other patients with complicated medical histories, who in the surgeon’s judgment present risk factors such that breast implant safety and effectiveness have not been established. As with all surgery, you should review your patient’s medical history to ensure that she is an appropriate candidate for breast implant surgery.

2. Surgical Precautions

• 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 be consistent in size with the patient’s chest wall dimensions, including base width measurements, bearing in mind the laxity of the tissue and the projection of the implant.

➢ 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 implant extrusion, hematoma, infection, palpable implant folds, and visible skin wrinkling requiring surgical intervention to correct these complications.1



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