04162014Headline:

West Palm Beach, Florida

HomeFloridaWest Palm Beach

Email Armand Rossetti Armand Rossetti on LinkedIn Armand Rossetti on Twitter Armand Rossetti on Facebook
Armand Rossetti
Armand Rossetti
Contributor •

The FDA Transvaginal Surgical Mesh Placement Complications Notification: Manufacturer Identification, and MAUDE Report Breakdown by Device

Comments Off

On October 20, 2008, The FDA issued a dear healthcare practitioner notice, concerning complications associated with transvaginal placement of surgical mesh for certain procedures. The notification indicated that the FDA had received over 1,000 reports from nine surgical mesh manufacturers. However the FDA did not identify the manufacturers or devices, and the FDA did not provide time ranges for the MAUDE reports. Therefore, I have made an attempt to identify the manufacturers and to provide further information concerning the MAUDE reports. The following chart contains the information that I have found:

Manufacturer

Product Name (Device)

Number of MAUDE Events

Date Range

American Medical Systems

SPARC

65

02/21/2002 to 06/21/2007

Bard

Pelvicol

64

10/15/2001 to 05/08/2008

Pelvisoft

1

Boston Scientific Scimed

Prefyx PPS

23

08/11/2006 to 9/3/2008

Obtryx Curved Single

1

On 01/10/2006

Obtryx Mesh Sling

62

08/24/2005 to 09/18/2008

Advantage Sling System

29

07/25/2006 to 09/19/2008

Prefyx System Mid U

23

08/11/2006 to 09/03/2008

Mesh Sling System

78

08/19/2004 to 09/18/2008

Caldera

T-Sling

2

06/15/2004 to 11/26/2007

Ethicon

Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor

123

04/14/2004 to 03/02/2008

Prolene Polypropylene Mesh

72

01/28/2002 to 09/18/2008

Gynecare

Secur

1

Single Report on October 4, 2007

TVT (See Ethicon, Inc. and Johnson & Johnson) (K974098)

4

07/21/2003 to 10/04/2007

Johnson & Johnson

Tension-Free Vaginal Tape (K974098) Also Medscand Medical Lab (Sweden), Ethicon, Inc., Ethicon Sarl (Switzerland),

495

05/12/1999 to 02/27/2007

Mentor

ObTape (K031767)

236

11/01/2002 to 10/19/2007

Sofradim

Uretex TO

64

10/23/2002 to 05/08/2008

Avaulta Biosynthetic

0

Uretex Pubovaginal Sling/support kit

27

10/24/2002 to 04/22/2008

Bard Posterior Biosynthetic Support System

3

06/14/2007 to 09/14/2007

Pelvetex Polypropylene Mesh

0

In the event that I have not reported information correctly, I welcome readers to email me with more accurate information if it is available.