Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Initial Communication (March 11, 2010)

Updated information regarding the Class I Recall and safety investigation of counterfeit polypropylene surgical mesh is available as of June 10, 2010. The following is provided for historical purposes only.

Date Issued: March 11, 2010

Audiences: Healthcare Professionals, Patients, Hospitals and Surgical Centers, Operating Rooms, Operating Room Nurses, Purchasing Departments, Risk Managers

Medical Specialty: Surgery

Product:

Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes, specifically identified below, are NOT Bard-manufactured products. Surgical meshes of this kind are used to reinforce soft tissue where weakness exists in the repair of hernias and chest wall defects.

Summary of Problem and Scope:

FDA's and Bard's investigations show that the counterfeit product is labeled with the following product codes, sizes and lots of Bard Flat Mesh. To date four product sizes have been identified:

Although counterfeiting of surgical mesh has occurred in the past, we are not aware of any other counterfeit mesh products being distributed at this time.

Recommendations/Actions:

Healthcare professionals and facilities

• Do NOT use any surgical mesh, labeled as C.R. Bard, from the lots listed above.
• Carefully examine all manufacturers' polypropylene surgical mesh products, packaging and labeling for their lot numbers and anything unusual that might indicate they are counterfeit.
  • Contact Bard at 1-800-556-6275 if you think you have one of the counterfeit products.
  • Contact the manufacturer if you notice anything unusual or suspicious with any other brand of surgical mesh product, including its packaging or labeling.
• If you suspect that the counterfeit product was implanted in a patient, continue to monitor the patient for adverse events as you would any patient with an authentic polypropylene surgical mesh implant.
• Report any adverse events to FDA as instructed in the "Reporting Problems to FDA" section below.
• If you believe you have received counterfeit or suspect product, contact FDA's Office of Criminal Investigations by calling 800-551-3989 or by visiting the Office of Criminal Investigations web site.

Patients

• Contact your surgeon if you have been implanted with a surgical mesh product and are experiencing any problems with it.
• If you are scheduled for a procedure that may require the use of surgical mesh, talk to your surgeon before the operation so you are confident you are not receiving surgical mesh from any of the lots listed above.

FDA Activities:

FDA is gathering information about this situation to better understand its potential public health impact. The agency is also working to determine who may be responsible and how the counterfeiting and distribution occurred. At present we do not know if this counterfeit surgical mesh meets the authentic product's specifications, including its strength, sterility or clinical performance. We plan to test samples of the counterfeit mesh to better assess its potential risk to health, and we will issue updated information as it becomes available.

Reporting Problems to FDA:

Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect a problem with counterfeit surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

To help us learn as much as possible about the adverse events associated with counterfeit surgical mesh, please include the following information in your reports, if available:

• Manufacturer's name
• Product name (brand name)
• Date product was manufactured
• Expiration date
• Catalog number
• Lot number
• Size
• Date of implant
• Date of explant (if mesh was removed)
• Details of the adverse event and medical and/or surgical interventions (if required)

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@CDRH.FDA.GOV or 800-638-2041.

This document reflects FDA's current analysis of available information, in keeping with our commitment to promptly inform healthcare professionals and the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.