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“The Keller Funnel™ definitely makes the process of inserting a silicone implant easier, permitting a smaller incision, and less trauma to the implant shell and surrounding patient tissue.”
— Alan Gold, MD Great Neck, NY

Frequently Asked Questions

How many times can a Keller Funnel™ be used?

The Keller Funnel™ is intended for single use only. A single use includes a testing before insertion and both breast implantations of the same patient. It is not to be re-sterilized by any means and no testing has been performed to assure re-sterilization would be effective.

Can I speak with a surgeon who has used the device?

A Keller Medical representative will gladly assist you with your request. Please contact us via email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it or by phone: (772) 219-9993.

How can I learn how to use the device?

Please access our online training video and certification test to learn the specifics about using the Keller Funnel™.

Explain how the product uses a no-touch technique.

Open the sterile, double-pouched packaging of the Keller Funnel™ and submerge the device in saline or antibacterial solution. We recommend surgeons keep breast implants in their original packaging, submerged in saline or an antibacterial solution. While the surgeon holds open the wide end of the Keller Funnel™, the nurse can pour the implant from its original packaging directly into the funnel. Once tested and loaded properly, the surgeon places the funnel tip into the breast pocket and propels the implant into place using a no-touch technique.

How do hydrophilic coatings work?

The supporting polymer network is cross-linked and covalently bound to the substrate. This network is normally non-swellable in water. In LubriLAST™, a long chain, biocompatible hydrophilic polymer is incorporated into the coating. Part of this long hydrophilic polymer becomes entangled with the supporting network while other part remains exposed and able to become hydrated. When in the presence of water or body fluids, the hydrophilic polymer LubriLAST™ absorbs water molecules to create a watery interface at the surface of the device. The water cushion reduces wet friction, protein adsorption and cell adhesion.

Where can I find the Instructions for Use for the Keller Funnel™?

Keller Medical, Inc. has created an Instructions for Use PDF to ensure information on proper usage is available. Also available in Spanish.

Where can I find hospital ordering information, FDA registration, etc.?

Keller Medical, Inc. has compiled information to help facilitate discussions that hospital product board review committees may conduct. You can find it here.

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!

 
Upcoming Funnel
Demo Opportunities
Amelia Island, FL
June 3-6, 2012
 
Los Vegas, NV
June 6-10
 
St. Louis, MO
June 21-23, 2012
 
Santa Fe, NM
August 22-25, 2012
 
Jackson Hole, WY
August 30-Sept. 4, 2012