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MENTOR® SPECTRUM® Adjustable Saline Breast Implants
IMPORTANT SAFETY INFORMATION: See reference section below for a Black Box Warning for breast implants and important safety information
The innovative line of MENTOR® SPECTRUM® Adjustable Saline Breast Implants makes the decision-making process easier than ever. Exclusive to Mentor, it is designed with proprietary technology that consists of a removable fill tube that offers the option for physicians to increase or decrease the size of the implant for up to six months after surgery.
Features & Benefits
Highly Versatile
As the only post-operatively adjustable saline filled breast implant in the United States, the SPECTRUM® family of breast implants offer surgeons flexibility and control over their patient’s final aesthetic outcome for up to six months post-surgery. This control allows the clinician to customize the final result to satisfy patient preference and need.
Supporting Documentation
SPECTRUM® Smooth Round Implants
|
Catalog # |
Temp Vol. |
Min. Vol. |
Min. Final Vol. |
Min. Diam. |
Min. Proj. |
Max. Final Vol. |
Max. Diam. |
Proj. |
|
350-1410 |
125 cc |
105 cc |
125 cc |
9.4 cm |
2.7 cm |
150 cc |
9.3 cm |
3.2 cm |
|
350-1420 |
175 cc |
150 cc |
175 cc |
10.3 cm |
3.1 cm |
210 cc |
10.2 cm |
3.8 cm |
|
350-1430 |
225 cc |
190 cc |
225 cc |
10.8 cm |
3.5 cm |
270 cc |
10.9 cm |
4.3 cm |
|
350-1440 |
275 cc |
230 cc |
275 cc |
11.6 cm |
3.8 cm |
330 cc |
11.5 cm |
4.6 cm |
|
350-1450 |
325 cc |
275 cc |
325 cc |
12.4 cm |
4.0 cm |
390 cc |
12.1 cm |
4.9 cm |
|
350-1460 |
375 cc |
320 cc |
375 cc |
13.5 cm |
4.1 cm |
450 cc |
13.0 cm |
4.9 cm |
|
350-1470 |
425 cc |
360 cc |
425 cc |
14.0 cm |
4.2 cm |
510 cc |
13.7 cm |
4.8 cm |
|
350-1480 |
475 cc |
405 cc |
475 cc |
14.3 cm |
4.4 cm |
570 cc |
13.8 cm |
5.4 cm |
|
350-1485 |
525 cc |
450 cc |
525 cc |
15.0 cm |
4.4 cm |
630 cc |
14.4 cm |
5.6 cm |
|
350-1490 |
575 cc |
490 cc |
575 cc |
14.7 cm |
4.8 cm |
690 cc |
14.2 cm |
6.0 cm |
Product Insert Data Sheets
Single Use Sterile Saline Sizer Product Insert Data Sheet
Saline Breast Implant Product Insert Data Sheet
Important Information for Your Patients to Consider
Important Information for Women Considering Breast Implants
References
No applicable peer-reviewed references for this page.
Important Safety Information
WARNING:
- Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
- Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
- Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
Caution: US law restricts this device to sale by or on the order of a physician.
The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.
MENTOR® Saline-filled Breast Implants are indicated for breast augmentation in women at least 18 years old or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing.
Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery. The chance of developing complications increases over time. The most common complications with Saline- filled Breast Implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and deflation. Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual's risk of developing BIA-ALCL with MENTOR® Breast Implants is low based on the incidence of worldwide cases.
Patients should receive a copy of Saline-Filled Breast Implants, Making an Informed Decision. Your patient needs to read and understand the information regarding the risks and benefits of breast implants, with an opportunity to consult with you prior to deciding on surgery.
For detailed indications, contraindications, warning and precautions associated with the use of Saline-filled Breast Implants please refer to the Instructions for Use (IFU) provided with each product, or online at www.mentorwwllc.com.
157833-201102
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It is intended for visitors from the United States.
© Mentor Worldwide LLC 2021 Last Updated on 2/5/2021.