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:
1. 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.
2. 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.
3. Patients must be absolutely committed to completing the annual follow-up visits.
410 Silicone Breast Implants
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.
410 Silicone Breast Implants
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.
MRI of 410 Silicone Breast Implant
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.
MRI of 410 Silicone Breast Implant
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 reimbursement 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.