courtesy www.free-animations.co.uk.comDear Ones:
The Triad Alcohol prep pads and swabs and Triad 'Sterile' jelly lube story will just not go away.
I recently came across a MAUDE Report (Manufacturer and User Facility Device Experience Database) implicating Triad 'Sterile' Jelly Lube in a number of unsatisfactory liposuction results.
The MAUDE Report is dated 2004, but the page it is on was recently UPDATED on Feb. 28, 2011.
"THE TRIAD GROUP, DIVISION OF H & P INDUSTRIES TRIAD LUBRICATION JELLY LINK: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=611249
Event Date 06/01/2004 Event Description:
There is an urgent need for fda to investigate a product that is currently being used by plastic surgeons during liposuction procedures that is creating tremendous wound problems that have never been seen before. Between one hundred to two hundred pts have been adversely affected with scarring and infected foreign body reactions from the use of a lubrication jelly produced by triad. The use of triad lubrication jelly started in june 2004 when the johnson and johnson k-y jelly was discontinued. The local distributors substituted the triad brand lubrication jelly. The jelly is used during the liposuction procedure to keep the wound edges from being traumatized by the metal liposuction cannula that moves in and out of the wound several hundred times at a quick pace. Most plastic surgeons started noticing unusual wound healing problems around the incision sites that typically healed without any problems. The healing problems started with severe redness and induration followed by opening of the wound at 2-4 months and chronic drainage with cellulitis in many cases. In all cases the resulting scarring is far worse than the normal small line that forms after liposuction. In dec 2004 a group of plastic surgeons who use the same surgical facility came to the conclusion that the triad gel was the only factor in their procedures that had been changed. This particular group started contacting other plastic surgeons in the ensuring months and several other surgeons reported similar problems in every liposuction pt where the triad jelly was used. At plastic surgery meetings more and more surgeons were reporting this wound healing problem with the only common factor being the triad jelly. Triad was initially contacted by a physician in dec. 2004, but no letters or measures were taken to notify physicians or distributors about the potential problems in using jelly during liposuction. In feb. Of 2005 an official letter from triad was released by their quality control division stating that the jelly had successfully passed all the necessary quality controls and that the triad jelly was similar to other equivalent jelly being used in the market place. Again no letter was issued to physicians or the distributor of the product about the potential problem with this type of usage. There is a list of board certified plastic surgeons who have used triad jelly and have numerous pts in their practices with ongoing wound and scar problems. Reporter has been contacted by pt's attorneys as well as several other physicians who have pending law suits based on infections and scarring. Fda should open an immediate investigation and in the very least have triad circulate a warning to all physicians and distributors of the product. The physicians are willing to cooperate in any way to assist the fda in collecting info in a timely fashion."
Perhaps this information will be of some help to you.
With Love in Christ
Reverend Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"