California Personal Injury Lawyers Blog
How Are Hernia Mesh Products Regulated?
Who Is Regulating the Manufacturing of Hernia Mesh Products?
Products that are used in the medical field on patients in the American population are monitored by the United States Food and Drug Administration or FDA. The FDA reviews all Group II medical devices for safety and clears the regulations to ensure that the product is indeed safe for use by the medical practitioners and healthcare workers. The problem with these clearances is that many medical products are “cleared” by the FDA with only a general demonstration of being equal to a similar medical product already on the market.1 This process is called Premarket Notification or 510(k), and the FDA’s minimal requirements in this area can cause problems for consumers who are patients who receive a hernia mesh product later on that is defective or damaged.1
Why Are Hernia Mesh Products Mass Produced Without Being Checked?
This may be a question that only the FDA can answer, but because of low staffing or capped budgets, the FDA often “drops the ball” when it comes to verifying the safety of hernia mesh products. This may account for the many hernia mesh products that are recalled each year. If a hernia mesh product is recalled or withdrawn from the medical device market, the FDA should publish a report to that effect. This gives the consumers and patients more information on why a product is taken off of markets, such as if the product was unsafe or otherwise unsuitable for use in the medical environment for a patient. If you have been injured by a hernia mesh product that was damaged or defective, you can talk to a Los Angeles hernia mesh lawyer from our law firm. Just call us today at 866-INJURY2 or 866-465-8792, and we can answer your questions to initiate a lawsuit on your behalf.
Are New Hernia Mesh Products Tested Before Being Unleashed on the Public?
Yes, hernia mesh products need to be tested extensively before being released to the medical community for use on the public. For example, new hernia mesh products under the 501k process need to undergo many trials, such as blind trials, pilot randomized controlled trials and other clinical trials before they can be released as safe for use with the patients in the public realm.1 If you are injured by a new hernia mesh product that is not clinically tested or properly reviewed as safe for use with patients, then you may have a lawsuit against the mesh product manufacturer for the personal injury and harm you sustained. We can sort this all out for you, but you must call us first.
How Do I Find a Los Angeles Hernia Mesh Lawyer?
In general, if you have questions regarding the worth, value or settlement procedures related to a hernia mesh product lawsuit, call our Los Angeles legal team today. We are here for you, and you can call our law office today to talk about your concerns. We are available to take your call at the Law Offices of Gary K. Walch, and you can call us at 866-INJURY2 or 866-465-8792.
References
1Olavarria, O. A., Shah, P., Bernardi, K., Lyons, N. B., Holihan, J. L., Ko, T. C., … & Liang, M. K. (2020). Lack of regulations and conflict of interest transparency of new hernia surgery technologies. Journal of Surgical Research, 247, 445-452.