WHAT? ME WORRY?
CURRENT EVENTSCongradulations to me! I am soooo lucky. Nothing like having a medical implant device that has been RECALLED....
I mean, how do you recall sumpin' like this? It's not like taking your car in for a replacement part. What do I do? Wait for the thing to malfunction and tear up my insides? SHEESH!
FDA Recalls Additional Bard Composix Kugel Hernia Patches
By Yael Waknine
April 3, 2006 (updated April 21, 2006) — The US Food and Drug Administration (FDA) and Davol, Inc (a subsidiary of C.R. Bard, Inc), have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device (Bard Composix Kugel Mesh Patch) to include all lots of the oval "midline" size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.
The recall is due to the potential for breakage of the "memory recoil ring" under the stress of placement into the intraabdominal space, leading to bowel perforation and/or chronic enteric fistulae, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.
Surgeons and hospitals are advised to cease using the products with codes and lots affected by the recall and to return unused units to the company. Patients who have received one of the recalled devices should seek immediate medical attention if they experience symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unusual symptoms potentially related to ring breakage.
Further information for customers is available by contacting the company by phone at 1-800-FOR-BARD (1-800-367-2273) or by e-mail to bard.helpline@crbard.com. Physicians may contact the company's medical services and support division by phone at 1-800-227-3357 or e-mail to medical.services@crbard.com. Additional information regarding patient management is also available online at http://www.davol.com/HTMLFiles/hernia/recall.htm.
The device is indicated for the repair of ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The "memory recoil ring" allows it to spring open and lie flat behind the defect after having been folded for insertion through a small incision.
Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Reviewed by Gary D. Vogin, MD
ON A HAPPIER NOTE:
So I jump ship in Hong Kong and make my way over to Tibet...and I get on as a looper at a course in the Himalayas. A looper? A looper. You know, a caddy, a looper... ...a jock.
So I tell them I'm a pro jock and who do you think they give me?
The Dalai Lama, himself. The son of the Lama. With flowing robes, grace, bald, striking. I'm on the first tee with him. I give him the driver. He hauls off and whacks one. Big hitter, the Lama. Long!
Into a 10,000 foot crevice right at the base of this glacier!
Do you know what the Lama says? "Gunga galunga. Gunga gunga da gunga." So we finish and he's going to stiff me. And I say, "Hey, Lama! "How about a little something, you know, for the effort?"
And he says, "There won't be any money... "...but when you die, on your deathbed... "...you will receive total consciousness."
So I've got that going for me... which is nice.
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