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Emory University
researchers find the
Keller Funnel reduces
chances of contamination
in silicone breast
augmentations -
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Frequently Asked Questions

What is the Keller Funnel™?

The Keller Funnel™ is a single use, cone-shaped device that assists in the delivery of pre-filled implants during breast augmentation procedures. Surgeons who use the Funnel can offer patients a no-touch technique to prevent contamination. Made of nylon, the interior of the Keller Funnel™ is lined with a hydrophilic coating which becomes extremely lubricious when submerged in a saline or sterile solution.

How and why is the Keller Funnel™ used?

The Keller FunnelTM is used to allow surgeons to deliver the silicone gel implant into the surgical pocket of the patient while offering a minimal or no-touch technique. 

The surgeon opens the sterile, double-pouched packaging of the Funnel and activates the hydrophilic coating by submerging or wetting it with saline or antibacterial solution, which makes the interior of the Funnel very slippery.  The implant is then poured directly into the Funnel, which has been trimmed to size according to the volume of the implant.  The surgeon then places the distal,or small, end into the prepared breast pocket and with a squeezing or pushing motion, propels the implant easily into place.

 

Surgeons experienced in using the Keller FunnelTM report that the device:

  •  Employs a no-touch delivery techinique

  •  Decreases surgery time

  •  Decreases physician fatigue

  •  Limits local stress on implant shell, which may lead to rupture

  •  Reduces incision lengths

  •  Lessens trauma to patient tissue

  •  Reduces amount of skin contact and possible tissue contamination

How do implants become contaminated during the augmentation procedure?

The breast is not a sterile organ; it has colonized bacteria living within nipple ducts which run deep into the breast tissue, which if violated, can lead to contamination.  More importantly, a patient's skin may not be sterile at the time of implantation - even with proper surgical preparation at the beginning of an operation, there is no guarantee of a completely sterile surgical field.

 

In the traditional augmentation surgery, vigorous finger pushing required by surgeons to insert silicone implants through small incisions can increase the contamination of the implant surface with breast skin florae, elevating the risk of contamination and subsequent capsular contracture.

Why was the Keller Funnel recently involved in an Emory University study?

Lead Emory researcher, Hunter Moyer, M.D. wanted to find out if using the Keller Funnel would reduce the amount of skin contact at the incision site and potential skin tissue contamination during breast implantation.  He found the Funnel demonstrated a 27-fold decrease in skin contact compared to the traditional finger insertion technique.  Also, bacterial transfer to the implant shell was reduced by nearly 50 percent.  Dr. Moyer believes that the use of the Funnel may help reduce overt infections and capsular contracture.

 

Can the device be used with all varieties of gel implants?

Yes, both smooth round, textured round, and anatomical (form stable) implants up to 800cc have been used successfully with the Keller Funnel™.  Note: textured implants or form stable implants require using slightly more force than smooth gel implants, and will require larger trim sizes.  See training video for additional information.  Additionally, the Keller Funnel™ has been used successfully in pectoral and gluteal implant procedures.

Is the Keller Funnel™ reusable?

No. The Keller Funnel is approved as a disposable device intended for single patient use. There is no data to indicate the device can function effectively under reprocessed conditions and whether resterlization could harm the integrity of the interrior hydrophilic coating.

Can the Keller Funnel™ be used in transaxial, periareolar and mammary fold procedures?

Yes, the Keller Funnel™ can be used in all three procedures. Keller Medical, Inc., however, recommends that surgeons using the product for the first-time try inserting with an inframammary fold or periareolar approach.

Can the Keller Funnel™ be used in pectoral and gluteal implant procedures?

Yes, the Funnel has been successfully used in both pectoral and gluteal implant procedures.  For more detailed information about the techniques, please email This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call (772) 219-9993.

Are there any biocompatibility issues with the hydrophilic coating and the surface of the gel implant?

No, the company uses Lubrilast™, a proprietary hydrophilic coating manufactured and applied by AST technologies of Billerica, MA. LubriLAST™ passes all stringent biocompatibility tests associated with tissue and blood contacting devices.

For more information about LubriLAST™, please visit http://www.astp.com/coating/lubrilast.html.

How can I get more information about the Keller Funnel™?

Contact Keller Medical, Inc. with any questions or comments - This e-mail address is being protected from spambots. You need JavaScript enabled to view it .  Call us at 772.219.9993.  Review the research and data on our website, see what surgeons are saying about the Funnel!

What is Capsular Contracture?

Capsular contracture is an abnormal response of the immune system to foreign materials in the human body, and is the leading cause for revisional breast surgery.  Medically, it occurs mostly in context of the complications from breast implants and artificial joint prosthetics.

 

Capsular contracture occurs when the collagen-fiber capsule tightens and squeezes the breast implant; as such, it is a medical complication that can be very painful and discomforting, and might distort the aesthetics of the breast implant and make the breast appear and feel hardened.  Although the cause of capsular contracture is unknown, factors common to its incidence include bacterial contamination, rupture of the breast-implant shell, leakage of the silicone-gel filling, and hematoma.

 
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“One is not born a woman, one becomes one.”
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