Mentor Device Data Sheets

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Mentor MemoryGel™ Silicone Gel-Filled Breast Implants

Description: 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.

Mentor Saline-Filled and Spectrum^® Mammary Prostheses

Description: Mentor’s Saline-Filled and Spectrum™ Mammary Prostheses are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. The silicone elastomer shell is inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation for the Spectrum implants. The implants are available with Siltex^®* textured or smooth surface shells.

Siltex^® and Smooth-Surface Low-Bleed Gel-Filled Mammary Prosthesis
(Reconstruction Adjunct Study)

Description: The Mentor Siltex^®* and Smooth-Surface Low-Bleed Gel-Filled Mammary Prostheses are silicone elastomer mammary devices. The gel-filled shell is constructed of successive cross-linked layers of silicone elastomer, which give the prosthesis its elasticity and integrity. The Siltex shell is textured to provide a disruptive surface for collagen interface.

Becker Expander/Mammary Prostheses
(Reconstruction Adjunct Study)

Description: Each implant in the Becker Expander/Mammary Prosthesis family of devices has a low-bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The resulting devices combine some of the advantages of tissue expanders with the feel of a gel mammary. In order to provide a prosthesis with elasticity and integrity, the outer and inner shells are made with successive cross-linked layers of silicone elastomer. The textured Siltex,* shell provides a disruptive surface for collagen interface. The silicone elastomer fill tube is pre-inserted into the dual self-sealing valve system at the time of manufacture and is adjoined to the injection dome by the connector system at the time of surgery. Two types of connector systems and injection domes are provided with each Becker product and either may be used. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube and injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.

The saline-filled inner lumen of the Becker Expander/Mammary Prosthesis provides the physician with the ability to control, within specified limits, the amount of expansion desired.

Contour Profile^® Tissue Expander With Bufferzone™ Area

Description: The Contour Profile® Tissue Expander is used for breast reconstruction following mastectomy. In order to provide a Tissue Expander with elasticity and integrity, the shell is made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detected, injection site, and incorporates a BufferZone™ area with self-sealing technology (containing silicone oil) to the front patch of the device in order to minimize and/or prevent device leakage in the event of an accidental needle puncture. The Siltex® textured shell provides a disruptive surface for collagen interface. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Identification of the injection port site can be accomplished by use of either the Centerscope™ magnetic detection device provided with the Tissue Expander, The Detector™, or by palpation of the raised outer ring of the injection port. To use the Centerscope™ magnetic detection device or The Detector, follow the instructions provided with the specific port detection device. Injections must be made using sterile, pyrogen-free Sodium Chloride U.S.P. Solution for Injection and into the area enclosed within the palpation ring. If injections are made on or outside this palpation ring, leakage can occur.

NeoForm™ TUTOPLAST® PROCESSED DERMIS

Description: Dehydrated Human Dermis Tutoplast processed Dermis consists of human collagen. All tissues are selected in compliance with stringent specifications governing donor selection and serological testing in order to minimize the risk of transmitting infectious diseases. Tutoplast processed Dermis is preserved by a defined, proprietary process consisting of meticulous cleaning of the tissue and gentle solvent dehydration monitored by continuous quality controls. The process does not result in chemical residues and reduces the antigenic properties of the original tissue. Preservation also includes sterilization of the finished product by gamma irradiation.

 

 

* Registered in the U.S. Patent and Trademark Office and other countries around the world.