FDA NEWS RELEASE
For Immediate Release: March 11, 2010
Media Inquiries: Peper Long, 301-796-4671,
mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
The U.S. Food and Drug Administration today warned health care
providers and consumers about counterfeit surgical mesh being
distributed in the United States under the C. R. Bard/Davol brand
name. Surgical mesh products are used to reinforce soft tissue
where weakness exists.
The warning is of particular significance to health care
professionals and their patients with surgical mesh implants as
well as hospitals and surgical centers, operating room medical
professionals and staff, and purchasing and risk managers.
Investigations by the FDA and Bard show that the following
products, sizes and lots of counterfeit flat sheet polypropylene
surgical mesh are not manufactured by Bard. To date, four product
sizes have been identified:
0112650 – Bard Flat Mesh 2"x
4"
Lot 43APD007 |
Lot 48HVS036 |
0112660 – Bard Flat Mesh 10"x 14"
Lot HURL0336 |
Lot HUSD0629 |
| 0112680 – Bard Flat Mesh 3"x 6" |
Lot 43HPD027
Lot 43HPD032
Lot HUSG0540
Lot 43HDP027 |
| Lot HUSE0532 |
Lot 43LPD507
Lot HUSF0763
Lot 43IOD011
Lot 43IPD038 |
| 0112720 – Bard Flat Mesh 6" x
6" |
Lot 43FQD327 |
The FDA is recommending that health care professionals:
Do not use any counterfeit Bard surgical mesh from the lots
listed
Carefully examine all manufacturers' polypropylene surgical mesh
products and packaging for lot numbers and anything unusual that
might indicate counterfeit mesh
Contact Bard at 800-556-6275 if they think they have one of the
counterfeit products
Contact the particular manufacturer if they notice anything unusual
or suspicious with any other brand of surgical mesh product or
packaging.
The FDA also recommends that health care professionals continue
to monitor patients for adverse events as they would any patient
with an authentic polypropylene surgical mesh implant, if they
suspect or know that counterfeit mesh has been implanted.
Patients should contact their surgeon if they experience
problems that they think may be related to surgical mesh.
The FDA continues to gather information and data on the
counterfeit mesh to better understand its potential public health
impact. The agency also is working to determine who may be
responsible and how the counterfeiting and distribution
occurred.
At this time, the FDA does not know if the counterfeit surgical
mesh meets the authentic product's specifications, including its
strength, sterility, or clinical performance. The FDA assessment of
the counterfeit mesh and its potential risk to health is
ongoing.
Health care professionals who believe they have received
counterfeit or suspect product are asked to contact the FDA's
Office of Criminal Investigations at 800-551-3989 or by visiting
the Web site at http://www.fda.gov/OCI.
Prompt reporting of adverse events can help the FDA identify and
better understand the risks associated with medical devices. If you
suspect a problem with this or any counterfeit surgical mesh, the
FDA encourages you to file a voluntary report through MedWatch, the
FDA's Safety Information and Adverse Event Reporting Program.
Health care professionals and consumers are encouraged toreport
serious adverse events (side effects)that may be related to theuse
of these counterfeit products to the FDA's MedWatch Adverse Event
Reporting program either online, by regular mail, fax or phone.
Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500
available at:
www.fda.gov/MedWatch/getforms.htm . Mail to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-332-1088
Health care providers employed by facilities that are subject to
FDA's user facility reporting requirements should follow the
reporting procedures established by their facilities.
For more information:
FDA's Initial Communication: Safety Investigation of Counterfeit
Polypropylene Surgical Mesh
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm203886.htm