Dozens of defective hernia mesh medical devices have been recalled. Some were recalled by the Food and Drug Administration (FDA), although most were voluntarily recalled by the hernia mesh manufacturers after several patients reported injuries from having hernia mesh.

The table below provides the hernia mesh recall list updated for 2020:

People who sustained injuries from their recalled hernia mesh may be able to sue the device manufacturer for:

• negligence,
• defective design, and/or
• failure to warn

If your attorneys successfully prove that hernia mesh injured you, you may be able to recover sizable hernia mesh compensatory damages to cover the following expenses:

• medical bills,
• pain and suffering,
• lost wages (including tips and bonuses), and
• loss of future earnings

In this article, our medical device attorneys provide an overview of the FDA recall processes that matter to you and your potential hernia mesh lawsuit.

• 1. What is a recall?
  • 1.1 Class I FDA Recall
  • 1.2 Class II FDA Recall
  • 1.3 Class III FDA Recall
• 2. How are medical devices like hernia mesh implant recalled?
  • 2.1 Manufacturer Voluntary Recall
  • 2.2 FDA Request for Recall
  • 2.3 FDA Order for Recall
• 3. Are there alternatives to an FDA Recall?
• 4. When does the FDA terminate a recall?
• 5. What to do if you want to file a complaint with the FDA? Or file a claim against the manufacturer?

1. What is a recall?

A recall is 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 does a voluntary hernia mesh recall.
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, such as 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 the 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 a 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 a notification to the manufacturer.

The manufacturer may also request the 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 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. (Learn more about hernia mesh adverse events and hernia mesh warning letters to manufacturers.) 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.

The FDA 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.

At Shouse Law Group, we are accepting hernia mesh cases regardless of 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. If you or a loved one has been injured by or experienced serious complications from a surgical mesh defective product, contact our office today by completing the below online form or calling our law firm for a case evaluation.

Related articles

• Additional surgeries (revision surgery)
• Adhesions (such as to organs or to the abdominal wall)
• Atrium Medical (C-Qur mesh)
• Bowel obstruction (blockage)
• Ethicon Physiomesh flexible composite mesh
• Hernia mesh complications from implantation (such as shrinkage or seromas)
• Infections (including at the surgical site)
• Lawsuits (such as class actions and MDLs)
• Mesh migration following hernia repair surgery
• Side effects
• Types of surgical mesh implants
• Type of hernias (such as inguinal hernias and ventral hernias)

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 and 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.