What You Should Know About Hernia Mesh Devices & FDA Recalls

The Food and Drug Administration (FDA) is responsible for issuing recalls on medical devices when it believes that a device is defective in some way or otherwise a danger to consumers. For instance, it has recalled hernia mesh devices that have presented a risk of injury to consumers. The FDA, however, does not always make recalls when it seems obvious it should. In many hernia mesh cases, the FDA has recalled some but left others -- considered defective and dangerous by many physicians and consumers -- untouched.

Here, we try to identify and provide an overview of the FDA processes that matter to you and your potential hernia mesh lawsuit.

Hernia mesh operating room
The Food and Drug Administration (FDA) is responsible for issuing recalls on medical devices when it believes that a device is defective in some way or otherwise a danger to consumers, including hernia mesh devices.

1. What is a recall?

A recall is a removal or correction of a medical device on the market in the United States. The FDA designates a class corresponding to the degree of potential harm to each recall items. There are three classes of recalls based on the potential danger the hernia mesh poses to the consumer. 1

1.1 Class I FDA Recall

A Class I recall means a medical device poses the highest level of concern for consumer safety. When the FDA issues a Class I recall, “a reasonable probability that the use of or exposure to” a particular “product will cause serious adverse health consequences or death.”

In a Class I situation, the company's who product is recalled must notify all customers and advise them to notify intended recipients of the recall. In addition to the notification, a press release to inform the public is necessary when appropriate to reduce health consequences.

1.2 Class II FDA Recall

A Class II recall means a medical device poses a risk to consumer safety. Specifically, a Class II recall means it has been determined that the subject medical device “may cause temporary or medically reversible adverse health consequences” or that a likelihood of “serious adverse health consequences is remote.”

Most hernia mesh recalls have been designated with Class II status. Under this designation, the company whose product is recalled must notify customers and advise them to notify intended recipients of the recall. A press relate is also required only when there is a specific need -- like if there are a large number of people who may have been or could be affected.

1.3 Class III FDA Recall

A Class II recall means the FDA has determined the medical device is “not likely to cause adverse health consequences.” In these cases, a notice is sent to all customers, but a press release is not necessary.

2. How are medical devices like a hernia mesh implant recalled?

There are three ways a recall can be made of a hernia mesh device. These three ways are:

  1. The manufacturer voluntarily recalls the hernia mesh.
  2. The FDA request the manufacturer to recall the device.
  3. The FDA orders the manufacturer to recall the device “under statutory authority.”

2.1 Manufacturer Voluntary Recall

When a company is aware that its medical device is manufactured is defective in some way that poses a risk to consumers' health, it should take upon its own initiative a recall of the item. This awareness may come about upon its own recognition or by FDA notice. The recall is meant to remove the marketed item so that the manufacturer can correct the issue.

Reasons for recalls by the company include:

  • A medical device was misbranded, meaning in part it was accompanied by false or misleading claims or the labeling was incorrect or inaccurate. 2
  • A medical device was adulterated, meaning the device does not meet the performance standard established under the FD&C Act. 3
  • The company violated the FD&C Act in some way and that violation is associated with the product in some way. 4

When a company recalls a medical device, it has certain responsibilities to the FDA. It must report a health risk immediately to the company's FDA district office. It must also submit a written report within 10 days of the correction or removal. The written report must include specific information, including but not limited to:

  • Report number of the correction or removal
  • Manufacturers name, contact person, contact number
  • Importers name, contact person, contact number -- if applicable
  • Brand name of the device, common name of the device -- if relevant, and the device's intended use
  • Marketing status and related information, like lot and serial numbers
  • Description of event(s) initiating the recall
  • Actions to be taken to correct the issue (both already taken and anticipated to be taken)
  • Any illnesses or injuries related to the event giving rise to the recall or to the use of the product
  • Total number and dates of manufactured devices affected by the recall
  • Names and contact information of all consignees and total number of devices sold to each
  • Copies of all related communications. 5

If any of the required information is not available at the time the report is submitted to the FDA, a statement must be included that explains the absence of the data. The company must also provide status report to the FDA to keep the agency abreast of any progress with the recall effort.

2.2 FDA Request for Recall

When the manufacturer does not recall a product that could be a risk to consumers, then the FDA steps in with a more active role. The FDA will consider if a recall is necessary to protect the public's health and welfare.

The Center for Devices and Radiological Health (CDRH) arm of the FDA will conduct a health risk assessment. This assessment is used to evaluate and/or confirm the risk. The CDRH discusses the findings with the company before requesting a recall.

2.3 FDA Order for Recall

When a manufacturer of a medical device refuses to respond to an FDA request for a recall, the FDA can order the same. A recall ordered by statute is mandatory. 6

3. Are there alternatives to an FDA Recall?

When the manufacturer is reluctant to conduct a recall, the FDA will pursue a recall on its own. But that is not the FDA's only recourse. It can take other action, especially when the consumers' health is at stake.

As alternatives to a recall, the FDA can:

  • Seize the medical devices.
  • File a Complaint for an injunction.
  • Place the manufacturer on import alert -- if it imports its devices, which most hernia mesh manufacturers do.

4. When does the FDA terminate a recall?

The FDA terminates recalls

when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.

When the FDA terminates a recall, it issues notification to the manufacturer.

The manufacturer may also request termination by written request to its district FDA recall office. This request should include:

  • A statement that the recall has been effective and has been in accordance with the criteria established by the FDA;
  • The most current recall status report; and
  • A description of the current nature of the recalled medical device -- in this case, hernia mesh implant.

If the FDA concurs, it will issue a written notice to the company and terminate the recall. 7

5. What are recent hernia mesh recalls that could have or could be affecting you?

The below table provides an overview of the most recent recalls of hernia mesh products.

Date Posted

Recall
Class

Mesh Product

FDA Reason

Termination Date

2/23/18

2

Atrium ProLite

Under investigation for incorrect configuration

Open

8/9/13

2

Atrium C-QUR Edge

Package design/selection
(adherence)

3/18/16

8/9/13

2

Atrium C-QUR TacShield

Package design/selection
(adherence)

3/18/16

8/9/13

2

Atrium C-QUR

Package design/selection
(adherence)

3/18/16

8/9/13

2

Atrium C-QUR V-Patch

Package design/selection
(adherence)

3/18/16

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 8" Circle

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS™ 7"X9"

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 6"X8"

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 6"X10"

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 6" Circle

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 8"X10"

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 4.5" Circle

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 12"X14"

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight ST Mesh with Echo PS" 10"X13"

Packaging process control

12/23/15

6/2/14

2

Bard Composix L/P Mesh with Echo PS" 8"X10"

Packaging process control

12/23/15

6/2/14

2

Bard Composix" L/P Mesh with Echo PS" 7"x9"

Packaging process control

12/23/15

6/2/14

2

Bard Ventralight" ST Mesh with Echo PS" 4"x6"

Packaging process control

12/23/15

1/23/14

2

Bard Composix L/P with Echo PS 10" X 13"

Labeling Change Control

12/23/15

1/23/14

2

Bard Composix L/P with Echo PS 6" X 8"

Labeling Change Control

12/23/15

9/20/12

2

Bard Ventralight ST Mesh. - Ellipse 8" x 10"

Mixed-up of materials/components

9/3/13

9/20/12

2

Bard Ventralight ST Mesh. - Ellipse 7" x 9"

Mixed-up of materials/components

9/3/13

5/23/11

2

Bard Soft Mesh 4"x6" Flat

Labeling mix-ups

10/28/11

5/2/11

2

Bard Ventralex" Hernia Patch Medium Circle

Labeling mix-ups

10/27/11

11/23/10

2

Bard Mesh Pre-shaped

Process Control

10/27/11

5/4/10

2

Bard Ventrio Small Oval Hernia Patch 8cm X 12cm

Labeling mix-ups

10/27/11

1/28/09

3

Bard 3D Max Mesh, Pre-formed Knitted Polypropylene

Mixed-up of materials/components

5/2/12

2/22/06

1

Bard Composix Kugel Mesh X-Large Patch

Oval with ePTFE, 7.7'' x 9.7''

Memory recoil ring could break & lead to bowel perforation, chronic enteric fistula

Completed

2/22/06

1

Bard Composix Kugel Mesh X-Large Patch

Oval with ePTFE, 10.8'' x 13.7''

Memory recoil ring could break & lead to bowel perforation, chronic enteric fistula

Completed

2/22/06

1

Bard Composix Kugel Mesh X-Large Patch

Oval with ePTFE, 8.7'' x 10.7''

Memory recoil ring could break & lead to bowel perforation, chronic enteric fistula

Completed

4/3/14

2

Ethicon Proceed

Under investigation by firm for incomplete seal & sterility

Open

1/14/11

2

Ethicon Proceed

Nonconforming material/component (delamination)

Open

1/26/06

2

Ethicon Proceed

Delamination & polypropylene concerns

9/28/06

2/1/11

2

Covidien AutoSuture SURGIPRO Polypropylene Mesh Clear 3" x 5"

Packaging process control (sterility issue)

1/10/13

 

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6. What to do if you want to file a complaint with the FDA? Or file a claim against the manufacturer?

If you or your physician believe you have been injured by a defective mesh product, it is in your best interests to alert the FDA of the same via a formal complaint or adverse report. To file a report, you can:

  • Report the event or injury online. 8
  • Complete Consumer Reporting Form FDA 3500B and either fax or mail it to the FDA per the instructions. 9
  • Call the FDA at 1-800-FDA-1088, or
  • If a doctor or healthcare professional reporting the event, completed Form FDA 3500 and either fax or mail it to the FDA per the instructions. 10

Your second option is to file the lawsuit for compensatory damages. Once a lawsuit is filed and the manufacturer and/or other defendants learn of the lawsuit, the manufacturer must report the lawsuit to the FDA.

At Shouse Law Group, we are accepting hernia mesh cases regardless where you live in the United States. Our personal injury law offices are located locally in California, but we represent clients who have been injured by hernia mesh products throughout the United States. Our personal injury attorneys are available to review your case and provide a detailed assessment. Contact our office today by completing the below online form or calling us at (855) 396-0370.

References

  1. U.S. Food & Drug Administration. Recalls Background and Definitions. See also, U.S. Food & Drug Administration Regulatory Procedures Manual (May 2018 - Chapter 7: Recall Procedures).
  2. U.S. Food & Drug Administration. General Controls for Medical Devices. See also, 21 CFR Part 502. Food, Drug & Cosmetic Act.
  3. U.S. Food & Drug Administration. General Controls for Medical Devices. See also, 21 CFR Part 501. Food, Drug & Cosmetic Act.
  4. Id.
  5. U.S. Food & Drug Administration. Compliance Program Guidance Manual, Attachment $, Summary of Corrections and Removals - 21 CFR 806 Requirements.
  6. 21 CFR Part 810.13 and 518e of the Food, Drug & Cosmetic Act.
  7. U.S. Food & Drug Administration. Recalls, Corrections and Removals (Devices). Last updated 07/09/2018.
  8. U.S. Food & Drug Administration. MedWatch Voluntary Reporting Form.
  9. U.S. Food & Drug Administration. MedWatch Consumer Voluntary Reporting, Form FDA 3500B.
  10. U.S. Food & Drug Administration. MedWatch: For VOLUNTARY reporting of adverse events, product problems and product use errors. Form 3500.

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