Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

JANUARY 9, 2012 ~ The following is a list of the companies who received the letters from the Food and Drug Administration (FDA) January 3, 2012, requesting three years of followup studies on the complications associated with synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence.

This is unprecedented in that the FDA has not required mesh makers to conduct any studies on safety and efficacy either prior to marketing or afterward. See the background story here.

See a PDF link to two letters:

Letter - POP 522 Order - final - generic (2)-3 (pdf)

Letter - SUI 522 Order - final - generic (2)-1 (pdf)

FDA issued the following orders for Postmarket Surveillance Studies:

• 88 orders for postmarket surveillance studies to 33 manufacturers of urogynecologic surgical mesh for POP.
• 11 orders for postmarket surveillance studies to seven manufacturers of single-incision mini-slings for SUI.
• All manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh for POP and single-incision mini-slings for SUI devices. Data from these studies will enable the agency to better understand these devices and their safety profiles.

• Manufacturers that received the order(s) are listed below:

Pelvic Organ Prolapse

ACELLAMERICAN MEDICAL SYSTEMS INC.BIO-VASCULAR INC.BOSTON SCIENTIFIC CORP.BRENNEN MEDICAL INCC.R. BARD INC.CALDERA MEDICAL INC.COLOPLAST A/SCOOK BIOTECH INC.COUSIN BIOTECH S.A.R.LCRYOLIFE INC.ETHICON INC.GFE MEDIZINTECHNIK GMBHHERNIAMESH SRLKENSEY NASH CORPORATIONMACROPORE BIOSURGERY INC.MAST BIOSURGERY INC.MPATHY MEDICAL DEVICES, LTDNEOMEDIC INTERNATIONALORGANOGENESIS INC.OSTEOBIOLOGICS INC.PEGASUS BIOLOGICS INC.PROMETHEAN SURGICAL DEVICES INC.PROXY BIOMEDICAL LTD.RTI BIOLOGICS INC.SHELHIGH Inc.SOFRADIM PRODUCTIONSYNOVIS SURGICAL INNOVATIONSTEI BIOSCIENCES INC.TEPHA INC.COVIDIAN (TISSUE SCIENCE LABRATORIES PLC)W.L. GORE & ASSOCIATES INCXYLOS CORPORATION

Mini-slings

AMERICAN MEDICAL SYSTEMS INC.BOSTON SCIENTIFIC CORP.C.R. BARD INC.ETHICON INC.GYNE IDEAS LTD.MPATHY MEDICAL DEVICES LTD.PROSURG INC.

• Please note, these 522 orders do not cover abdominal sacrocolpopexy (ASC) for treatment of POP or Multi-Incision Retropubic or Transobturator SUI Slings