DO NOT LET YOUR SURGEON PICK YOUR DESIRED SIZE

I perform about 450 such procedures annually. Let me tell you what I have learned. The best way to choose your implant is to forget about cc's. Let the surgeon do that...it’s his job. What you should do is be able to communicate the look you are trying to achieve and often pictures of other people is a good place to start. There have been many times when a patient has told me they wanted to be a full c and then I see pictures depicting a d cup. It’s not exact but a good place to start. Take a look at the surgeon's before and after pictures to se if there are sizes which you find appealing. The measurements which we take are guidelines for some of the decisions which we make. They are not exact criteria for the size you should get and neither are the implant dimensions. There are certainly people who have chosen implants smaller than what their chest could accommodate and the corollary has occurred very often, as well. We are not the ones living with it. Unless there is a definite anatomic restriction it may be the time to get another opinion.

Now a few words about implants. Saline are still the most common in the U.S. but are they the best choice? Not in my humble opinion. I believe them to have too much rippling upon palpation. The only positive aspect is that they require a much smaller incision for placement. As for silicone, I find them to feel the most natural. Silicone implants are much different than the ones which were taken off the market in the early 90's. The shells are much thicker and the silicone gel is much thicker (cohesive). Cohesive is a term for all silicone and is confusing because there are varying degrees of cohesiveness. The old implants were cohesive but in such a state that they would leak. The new implants (cohesive I) will not leak but if cut in half and squeezed it will not return to the original shape. Cohesive II (Mentor Lumera) are much thicker such that they have a jello appearance when cut and will return to their original form after being squeezed. These are available only in textured and tear drop shape. They offer a bit less rippling than the cohesive I but are also a bit firmer and I believe less of an option for purely cosmetic reasons. The last is cohesive III (gummie bear) which are the thickest. I have not had as much experience with these but am a little discouraged by the feel (too firm) and the incision required (long and inframmamary position). The cohesive II and III are much less pliable and require a larger incision as they are not pliable and have memory of form. My last point...there is never a reason to put an implant above the muscle (subglandular) position. It is a setup for problems. It appalls me that some surgeons still do it that way.--- written by Dr. Hochstein

BREAST IMPLANTS

There are various types of breast implants available for breast augmentation. During your consultation with Dr. Hochstein, you will learn which implant is most suitable for your body. The decision about which breast implant type to use is based upon numerous factors, and should be agreed upon between you and your surgeon. This includes the type of breast implant, method of insertion, and placement.

• MemoryGel (Gummy Bear) Breast Implants
  
  FDA  Approved
  
  filled with Mentor's Proprietary silicone gel --MemoryGel-- that holds together uniformly while retaining the natural give that resembles breast tissue
  
  Set fill volume
  
  
  
  
  Three projections: Moderate, Moderate Plus High Profile
  
  Two shell surfaces available: smooth and textured
  
  Slightly larger incision size with various options for incision placement. (Talk with your doctor about the different options)
• Saline Breast Implant
  
  
  FDA Approved
  
  Filled with salt water solution similar to the fluid that makes up most of the human body, slightly firmer
  
  
  
  Flexible fill volume allowing the surgeon to adjust volume during the procedure. Also helpful if one breast is bigger then the other
  
  Three projections: Moderate, Moderate Plus High Profile
  
  Two shell surfaces available: smooth and textured
  
  Smaller incision size with various options for incision placement

Types of Breast Implants: Saline and Silicone

SALINE IMPLANTS

Saline implants are the predominantly-used implant for breast augmentation. The implants are essentially empty prior to placement, with the silicone shell filled once they are underneath the skin and in place. Most methods of insertion allow for very short incisions to be used during this procedure. The two main advantages of saline breast implants are the fact that they carry little controversy and should they rupture or leak, a patient can easily detect the problem. Saline is a saltwater solution and generally considered safer than silicone; the body should absorb the fluid should it enter the bloodstream. The major disadvantages of saline implants are their appearance and quality; they tend to look and feel less natural than silicone implants.

WHAT ARE MemoryGel™ IMPLANTS?

MemoryGel™ is the brand name for all of Mentor’s silicone gel-filled breast implants. MemoryGel implants are also referred to as (Gummy Bears). These are the same products we have been distributing under the Adjunct Study since 1992 for reconstruction and revision patients. MemoryGel™ implants contain a proprietary cohesive gel formulation that acts as a unit rather than a liquid, and holds together uniformly.

These round gel-filled implants come in three different profiles (Moderate, Moderate Plus, and High Profile), and in both smooth and textured surfaces. Mentor has been making breast implants for over 20 years. Over two decades has given us enormous experience, and a global reputation for integrity and continuity.

MemoryGel™ Smooth Round Moderate Profile Implant

• Widest Base
• Lower Profile

MemoryGel™ Smooth Round Moderate Plus Profile Implant

• Aggressive fill
• Moderate base
• Higher profile
• Features a proprietary cohesive gel

MemoryGel™ Smooth Round High Profile Implant

• Narrow base
• Highest projection
• Features a proprietary cohesive gel

SILICONE IMPLANTS

In the early 1990's it was reported that silicone breast implants were possibly responsible for connective tissue diseases in some women. Since the controversy began over the potential risks of silicone breast implants, researchers have been conducting scientific studies to investigate the safety of silicone implants. In 1999, a landmark report, undertaken by the Institute of Medicine (IOM) concluded that silicone implants do not cause major health problems such lupus or rheumatoid arthritis. In fact, there have been a number of major studies failing to find an association between implants and autoimmune diseases or cancer. And while no one can ignore the fact that silicone – and saline – breast implants may cause localized problems for some patients, numerous scientific studies over the years have shown that silicone gel-filled implants are both safe and effective for breast augmentation and reconstruction.

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SILICONE (COHESIVE-GEL) Also known as "Gummy Bear Implants"

The word cohesive is a new term being used today to describe the nature of the fill compared to the more liquid fill that may have been used in silicone implants in the early 1970’s. This is not a new science, this is not new technology – cohesive is simply a word that’s being used today to describe the “sticking together” nature of the gel. The gel acts as a unit rather then a liquid – it holds together uniformly and retains the natural give that resembles actual breast tissue. Because the gel is thicker than traditional silicone, these implants are less likely to leak, rupture, or tear.

A great advantage of Cohesive breast implants is their natural feel, which may be especially noticeable when compared to saline-filled implants. Both implants have a possibility of rupturing, although some plastic surgeons will state that silicone implants are less likely to produce rippling and have a more natural feel then saline implants.

The Gummy Bear is used in Europe and other parts of the world but still has restrictions here is the US. Cohesive gel implants, or "Gummy Bear" implants, were developed to help reduce the rupture rate and prevent the rippling effect. They are the latest types of silicone implants available on a restricted basis.

They are textured, anatomically shaped, with a firm feel that has lead to their “gummy bear” nickname. Gummy bear implants typically create a firmer feel than traditional silicone. Yet they are still a relatively new breast implant on the market, with restrictions similar to traditional silicone. There are advantages and disadvantages to any silicone implant; it is import to talk with the doctor to find out what works best for you.

During an initial consultation with Dr. Hochstein, you can learn if you qualify for the use of silicone breast implants.

FDA Approves Silicone Gel Breast Implants

On November 17, 2008, the FDA approved silicone gel implants. Now that the products have been determined to be safe and effective, the FDA will continue to monitor them by requiring each breast implant manufacturer (Mentor and Inamed) to conduct a large post approval study following which will follow about 40,000 women for 10 years after receiving breast implants. The FDA often requires post market studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events.

The FDA’s decision to approve these implants was based on a through review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, the FDA conducted inspections of each company’s manufacturing facilities to determine that they comply with the FDA’s Good Manufacturing Practices. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants.

In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, these issues will be addressed further in the post approval studies conducted by the companies.

About Silicone Gel

Silicon is the second most abundant element on earth next to oxygen. Silicones are actually a family of chemical compounds. They are made of silicon, which is naturally occurring element found in sand, quartz and rock. When silicon is mixed with oxygen, hydrogen, and carbon, it becomes silicone. Silicone can be made in a variety of forms. Low molecular weight silicones form oils. Middle molecular weight forms gels, and high molecular weight forms elastomers and rubbers. Silicone is found in many other types of implants, such as facial implants, artificial joints, drainage systems, etc.

Currently, Mentor and Inamed silicone implants have 3 layers of shell surrounding the silicone gel. This reduces the amount of gel bleed. It does, however, make the implants a bit firmer than they were years ago, but this is attributed to the thicker shell. Silicone gel breast implants, the silicone implants of today are still very soft and natural feeling.

Silicone gel breast implants come pre-filled, meaning that there is no fill to be added. The only real drawback to a pre-filled implant is that the incision will have to be a bit longer, depending on the size of the implant to be inserted. This is especially true for textured silicone, which is a somewhat firmer than the smooth silicone, due to the thickness of the shell. Another reason that textured silicone requires a longer incision is the fact that the shell is textured. Because silicone gel breast implants come pre-filled, they cannot be inserted via TUBA incision (nor can any other type of pre-filled implant).

Silicone is used not only in breast implants but also in implants located literally throughout every part of the body. It has been used: to construct heart valves and other cardio-vascular prostheses; to fashion catheters which are used for purposes ranging from drug delivery to cardiac monitoring;, in dentistry; in the gastrointestinal tract; as a facilitator for nerve regeneration; in ophthalmology; in the ear, nose, throat, and respiratory tract; as a prosthesis of ingredient in prostheses for many parts of the skeletal system; as a tissue expander, as a cosmetic agent for treatment of scars, and wrinkles; in the urogenital tract, including penile prostheses; and in many other applications.

Information courtesy of National Library of Medicine.

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IMPLANT SHAPE

Breast implants come in more than one shape, depending on the patient’s goals and Dr. Hochstein’s suggestion. Each patient considering breast augmentation should be individually evaluated regarding which implant shape is best for them – round or anatomic.

Anatomic breast implants, which are also known as “teardrop” breast implants, are fuller in the lower half. They are designed to look as natural as possible. Yet while this shape may work well for a select group of patients undergoing breast augmentation surgery, the anatomic implant is used sparingly. Because this design has a distinct vertical orientation, should the implant rotate, the appearance may become distorted.

Round breast implants are the leading style used for breast enhancement today. They are known to create a fuller look throughout the breast. An advantage of this design as compared to anatomic breast implants is that there is generally no adverse consequence should the implant rotates. Because it is round, there is no vertical or horizontal orientation. Due to gravity alone, the bottom portion of the breast will look fuller once the filler settles in. This creates contour similar to that of the anatomic breast implant, but avoids the risk of possible distortion.

SELECTION OF IMPLANT SIZE

Determining the appropriate implant size is one of the critically important steps in breast augmentation. An implant that is too small or too large produces an unsatisfactory result. Dr. Hochstein believes that the best and most natural results are achieved by selecting an implant that is proportional to a woman’s anatomic features. During each consultation, Dr. Hochstein devotes much time to this process and together with his patients finds an appropriately sized implant to help them achieve their desired results.

The best way to determine what size you want and need is to bring your plastic surgeon a nude photo, preferably a straight on shot and side profile. Also bring pictures of what is too small and what is too large. Don't forget to discuss cleavage. Many women print photos from Playboy.com. If you find a good plastic surgeon they should be able to help you obtain your desired result.

In order to accomplish the appearance you see in a bra add 15-20% to get the same look after surgery, especially if you are going under the muscle. For example, if you like 300cc, you'll need 345 to 350cc implants. Also, projection after surgery is less than what you see in the bra. Implants tend to be rounder and fuller. This is particularly true with sub muscular placement. However, anatomicals do have more projection than rounds.

Don't get too set on an cc size. The exact same size implants will look different on different women. Factors to considers when picking a size:

• Chest shape
• Rib size
• Breast shape
• Breast base dimension
• Breast volume
• Breast Width
• Tissue stretch characteristics
• Sternal depth
• Pregnancy history
• Weight
• Other

LOCATION OF INCISION

There are several places where an incision can be placed for breast augmentation: in the axilla (armpit), under the areolas, or under the breasts. (Although Dr. Hochstein usually reserves using an incision under the breast for patients who have a preexisting scar in this location). Dr. Hochstein is fluent in the use of all of these approaches; during your consultation you can decide what works best for you.

LOCATION OF IMPLANT PLACEMENT

Breast implants can be placed either under the breast tissue and over the pectoralis muscle, or under both the breast tissue and the pectoralis muscle. The vast majority of patients who undergo breast augmentation today have implants placed under the muscle. The reasons for this include a more natural result by having more tissue cover the implant and a lower rate of complications.

RECOVERY

Recovering from breast augmentation, as with any surgery, is a gradual process. Some patients recover more quickly while others may be a bit slower. In general, the recovery following these procedures is not difficult. The typical patient will experience some pain and discomfort and use pain medication for 2 to 3 days following surgery. Depending upon the patient’s occupation, most patients will return to work 4 to 5 days after surgery. After 1 to 2 weeks patients can resume non-impact lower body exercise. Four weeks after surgery they can resume impact exercises and 6 weeks following surgery they can resume upper body exercise. Visit our Before Surgery Care for more information on pre and post operative care.

RESULTS

While patients will of course see results immediately after surgery, there is always swelling that develops. During the first week after surgery, the breasts and surrounding area are swollen, the implants appear high and your nipples point downwards, (this is all very normal). Over the course of several weeks the swelling subsides and the tissues stretch to accommodate the implant creating a more natural appearance. Also it is very common for the areola to stretch along with the rest of the breast so your areolas will be bigger after surgery. (If your areolas are all ready large you may wish to have them reduced at the time of surgery). Refer to pictures below.

• 
  Weeks after surgery
• 
  Months after surgery

COMPLICATIONS

As with any surgery, complications can develop following breast augmentation. Fortunately complications are unusual. Some of the complications which can occur following augmentation are: bleeding; infection; capsular contracture; and deflation. Dr. Hochstein will discuss these with you in detail.

FOLLOW UP

Dr. Hochstein and his staff is committed to his patient’s care and well-being. Dr. Hochstein follows his patient's progress for an extended period and is always willing to ease any concerns and answer any question that may arise.

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MENTOR ADVANTAGE & MENTOR ENHANCED ADVANTAGE

Breast Implant Warranty Information

Effective May 1, 2005

LIFETIME PRODUCT REPLACEMENT POLICY

• Automatically applies to all recipients of Mentor breast implant products.
• Provides that regardless of the age of the implant, when confirmed deflation or rupture occurs, you are eligible for 1 to 2 no-charge replacement breast implant products of any size in a similar style.

THE MENTOR ADVANTAGE WARRANTY

The Mentor Advantage is free of charge to all patients who are implanted with Mentor saline-filled and silicone-filled breast implant products.

• Lifetime product replacement policy1
• # 10 years and up to $1200 financial assistance for operating room, anesthesia, and surgical charges not covered by insurance2
• Free contralateral (opposite side) implant replacement upon surgeon request
• Non-cancelable terms

THE MENTOR ENHANCED ADVANTAGE WARRANTY

This optional warranty is available for both saline-filled and silicone-filled breast implant products and, to be eligible, must be purchased for an enrollment fee of $100 within 45 days from implantation.3

• Lifetime product replacement policy1
• 10 years and up to $2400 financial assistance for operating room, anesthesia, and surgical charges not covered by insurance from the date of implant.2
• Free contralateral (opposite side) implant replacement upon surgeon request
• Non-cancelable terms

With both Mentor Advantage and Mentor Enhanced Advantage it is important to maintain your own records to ensure validation of your enrollment, as it is possible your doctor may not retain your records for the entire duration of the warranty.

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PRODUCTS COVERED

The Mentor Advantage and Enhanced Advantage (if purchased) coverages apply to all Mentor breast implants that are implanted in the United States and Puerto Rico after May 1, 2005 4 provided implants have been:

• Implanted in accordance with the Mentor package insert, current to the date of implantation, and other notifications or instructions published by Mentor
• Used by appropriately qualified, licensed surgeons, in accordance with accepted surgical procedures

EVENTS COVERED

The Mentor Advantage and Enhanced Advantage coverages apply to the following:

• Deflation due to crease fold failure, patient trauma, or unknown cause
• Loss of valve integrity

Other loss-of-shell-integrity events also may be covered by this program. Mentor reserves the right to determine if specific, additional events should be covered.

EVENTS NOT COVERED

The Mentor Advantage and Enhanced Advantage coverages do not apply to the following:

• Removal of intact implants due to capsular contracture, wrinkling, or rippling
• Loss of implant shell integrity resulting from reoperative procedures, open capsulotomy, or closed compression capsulotomy procedures
• Removal of intact implants for size alteration

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FILING FOR FINANCIAL ASSISTANCE

To file a Mentor Advantage claim for product replacement and/or financial assistance, the surgeon must contact the Mentor Product Evaluation Department at 1-866-250-5115 prompt #1 prior to replacement surgery.

For financial assistance claims, a patient-specific Release form will be generated that the patient must sign and return.

For either replacement or financial assistance claims, the surgeon must send the explanation, decontaminated Mentor breast implant(s) within six months of the date of explanation to:

Mentor Product Evaluation
3041 Skyway Circle North
Irving, TX 75038-3540

Upon receipt, review, and approval of the completed claim, including receipt of the explanted product and patient completion of a full general release, financial assistance will be issued.

This is a summary of Mentor’s Advantage and Enhanced Advantage coverages. It is an overview only and not a complete statement of the program. You may obtain a copy of the complete Mentor Advantage and Enhanced Advantage Limited Warranties for Saline-Filled and Silicone-Filled Breast Implants by writing or calling:

Consumer Affairs Department
MENTOR
201 Mentor Drive
Santa Barbara, CA 93111
1-800-525-0245

Mentor reserves the right to cancel, change, or modify the terms of the Mentor Advantage and Enhanced Advantage coverages. Any such cancellation, change, or modification will not affect the currently stated terms of the Mentor Advantage and Enhanced Advantage coverages for those already enrolled.

This website provides an overview of the Mentor Advantage and Enhanced Advantage Limited Warranties for breast implants. However, it is not intended to replace any discussion between you and your surgeon.

THIS IS A LIMITED WARRANTY ONLY AND IS SUBJECT TO THE TERMS AND CONDITIONS SET FORTH IN THIS DOCUMENT AND EXPLAINED IN GREATER DETAIL IN THE APPLICABLE MENTOR LIMITED WARRANTY. ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS, ARE EXCLUDED.

THIS REMEDY IS THE SOLE AND EXCLUSIVE REMEDY AVAILABLE. MENTOR SHALL NOT BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL LOSS, DAMAGE, OR EXPENSE ARISING DIRECTLY OR INDIRECTLY FROM THE USE OF THESE PRODUCTS. MENTOR NEITHER ASSUMES, NOR AUTHORIZES ANY OTHER PERSON TO ASSUME FOR IT, ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.

The terms in effect when original implantation occurs will apply at the time of claim.

1. Lifetime Product Replacement Policy: Mentor will provide replacement Mentor product of any size in the same or similar style as the originally implanted product free of charge for the lifetime of the patient. Upon surgeon's request, a different implant style may be selected (subject to a charge of the difference between product list prices). Refer to the Mentor Advantage Limited Warranty for eligibility and program details.
2. Operating room and anesthesia charges to be given payment priority. In order to qualify for financial assistance, you will need to sign a Release form
3. One warranty payout per enrollment fee; enrollment in the program for replacement device will require additional $100 enrollment fee
4. For breast implants implanted prior to this date, contact Mentor Corporation for information regarding any applicable warranty terms

Capsular Contracture - Woman who have had either elective or reconstructive breast augmentation may develop a condition call Capsular Contraction. This rare condition is one in which the breast implant begins to form a hardened shell around itself. Those who notice either a hardening or difference in the position of their breast implants should contact their surgeon immediately.

External Ultrasound - Treatment for Capsular Contraction has no-surgical option with early intervention. The analogy for capsular contracture is like "soft glue" forming around the implant. Treatment initiated early allows for "mold ability" of the implant before it can fully harden. Once the "glue hardens" treatment effectiveness is lessened. http://www.aspenrehab.com/cosmetic.html

When any implant is inserted the body reacts by forming a lining of tissue around it called the capsule.  In some cases the capsule begins to shrink, squeezing the implant that it surrounds.  Though the exact causes of capsular contracture are largely unknown, there are factors that can contribute to this complication, including: 

• Germ contamination during implantation
• Seroma (the development of extra fluid around implant)
• Hematoma (internal bleeding)
• Infection
• Smoking
• Placement of implant above muscle (when placed bellow the muscle capsular contracture occurs with less frequency)

Depending upon the severity the breast can feel firm or hard, become distorted, and begin to cause pain.  To cure or treat capsular contracture there are both surgical and non-surgical options. 

Non-surgical

• Prescribed antibiotics and Vitamin E.  While this is not always effective as a cure, many surgeons will suggest that patients take a regular dose of Vitamin E (Vitamin E most not be taken 2 weeks before surgery or 2 weeks after surgery) For the first year after augmentation as it helps to keep tissue soft.
• External Ultrasound.  May help reduce swelling and inflammation and does not involve any major risks. http://www.aspenrehab.com/cosmetic.html
• Accolate.  This anti-inflammatory used in the treatment of asthma has shown, in minor studies, to help regress capsular contracture.  This is a relatively new and experimental treatment with no long-term statistical data.

Surgical

• Open capsulotomy.  The capsule surrounding the implant is surgically cut open in order to release the implant.  After this is done, however, there is a chance of contracture occurring again.
• Open capsulectomy.  This is generally the most successful, as well as the most intensive, form of treatment.  The entire capsule is removed, allowing new tissue to form around the implant.  In some cases, surgeons will change the implant for textured Siltex implants. placement: Also if the implant is placed above the muscle the surgeon may place it underneath the muscle during capsulectomy in the hopes of better results.

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