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McGhan Style 410 Implant Study
Steven Teitelbaum, M.D., April 21, 2003

Dr. Teitelbaum is pleased to announce new enrollment opportunities for
patients interested in receiving the McGhan Style 410 implant.

Only about 30 surgeons participated in the initial FDA approved core
clinical study of 960 patients, which took place in 2001 and 2002.

The FDA has recently approved enrollment of an additional 480
patients, to be completed over the next six months by an even more
select group of surgeons.

Eligibility can only be determined after a thorough in-person history
and physical examination and discussion. Interested patients should
consider the following:


Dr. Teitelbaum will offer this only to patients who live in the
Southern California Area. Contact Inamed directly if you live
elsewhere and need the name of a participating surgeon.


Though this is a study, the usual breast augmentation charges apply.
However, the company gives patients a stipend for completing their
annual follow-up, which, after ten years, comes close to covering the
cost of the device itself.


Patients must be absolutely committed to completing the annual
follow-up visits.


Style 410 Breast Implants.


This implant has been sold in Europe since 1994, where it is now
McGhan's most popular implant. It has the same outer shell as the
McGhan 468, a textured teardrop shaped implant. But instead of being
filled with saline, or with the usual liquid silicone gel, it is
filled with a "cohesive" silicone gel, which is more like a soft
solid. As a consequence, it is purported to not be able to leak, and
to be much more resistant to developing folds or ripples than
"non-cohesive" fillers, such as the typical silicone gel or saline.

What makes this implant different? The shell is McGhan's biocell
textured shell, the same shell that McGhan has used for more than a
decade, in a variety of both saline and silicone gel implants. The
ingredients of the silicone gel filler are also identical to what
McGhan has used for years in its silicone gel implants. What changes
is only the ratio of ingredients in the mix, but the cohesive gel
filler in the 410 involves no new compounds. What is different is that
only a greater amount of "crosslinker" is used, which is essentially
the catalyst that gives the desired degree of liquidiness or solidness
to the gel.


The Style 410 Silicone-Filled Breast Implants were created by McGhan
Medical to provide another shaped alternative to the round breast
implant. These breast implants defy the one-shape fits all limitation
associated with traditional round breast implants. Style 410
Silicone-Filled Breast Implants are available in an innovative
combination of height, width, and projection options, ultimately
resulting in the largest selection of uniquely different breast
implants from which the plastic surgeon can choose. Each profile is
available in a full range of sizes designed to accommodate a wide
range of patient anatomies and personal preferences. The Style 410
represents a significant increase in shaped implant options in the
McGhan Medical product line.

Notice how the implant augments the breasts naturally and
proportionally, without any folds or ripples. The lower pole is
augmented more than the upper, yet the upper is naturally projected,
and the implant does not collapse.


Style 410 Breast Implant with a wedge cut out of it, demonstrating
how the CoheSIL® silicone gel fill does not leak.
Even under substantial pressure, the CoheSIL® silicone gel fill does
not leak.
Corner of a Style 410 Breast Implant being squeezed.
After pressure is released, the silicone gel fill returns to its
normal shape.
The shell of the 410 is the same "textured biocell" durable shell
that McGhan has used for years. Here it is shown held flat, after
being cut away from an implant.
Even under this great stress, the shell remains pliable and intact.

The CoheSIL® gel fill used in the Style 410 improves the ability to
design and manufacture shaped breast implants. The cohesive nature of
the Cohesil® gel fill serves to maintain implant shape with a single
lumen construction. The potential for reduced silicone migration of
Cohesil® gel in the event of implant rupture remains to be
established.

As already shown, the shell is extremely strong and resistant to
damage. But here, it is actually shown in the artificial condition of
having been totally stripped of its shell. It maintains its shape,
sitting upright like a peeled jelly bean, with the implant gel
remaining undistorted, neither rippling, folding, nor running. This is
the result of the "cohesive filler."

Participation in the study will require the patient to make annual
office visits for ten years. Limited compensation will be provided for
each scheduled office visit. Compensation from McGhan will be $100.00
per visit, increasing gradually to $200.00 for the 10TH year visit.
All other fees, including the services of the plastic surgeon and
products, are the responsibility of the patients participating in the
study.

Summary of 410 Style Breast Implant design innovations:


The CoheSILTM silicone fill is more cohesive than standard silicone
gel fills.

McGhan Medical Style 410 Breast Implants consist of CoheSILTM silicone
fill encased in a silicone elastomer shell. The shell features the
BIOCELL® textured surface and INTRASHIEL® barrier.

The CoheSILTM silicone fill is more cohesive than standard silicone
gel fills;

The BIOCELL® textured surface is designed to promote tissue adherence
which helps maintain the proper position within the surgical pocket,
and may reduce capsular contracture;

The INTRASHIEL® shell features a patented design to minimize silicone
diffusion;

Choice of uniquely different breast implant configurations provide the
capability for the plastic surgeon to optimize aesthetic results.

ConfidencePlusTM Breast Implant Replacement Program

The McGhan Medical ConfidencePlusTM Breast Implant Replacement Program
applies to all McGhan breast implants sold and implanted in the United
States, including the new 410 Style Breast Implants. ConfidencePlusTM
provides lifetime replacement and limited financial reimbur*****t in
the event of loss of product integrity, subject to certain conditions
as fully discussed in the ConfidencePlusTM literature. For more
information, please contact the McGhan Medical Customer Affairs
Department at 800.624.4261.


Contact us at 310.315.1121 for more information about the Style 410
Breast Implants Study.


Article Courtesy of Steven Teitelbaum, M.D. - Santa Monica, California


"Because there are things women need to know about breast implants and
augmentation"

http://www.breastimplants411.com/dbii/articles.asp?Article_ID=32