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FDA warns of defects caused by Minnesota company


Minnesotans trust their doctors to give them the best available treatment for illnesses and diseases that are available. Medical devices have come a long way in the past few decades in making peoples' lives more comfortable and healthy. However, not every medical product created is safe. Some defective products have the potential to cause serious injuries and even death.

The U.S. Food and Drug Administration has recently issued a warning about a certain type of medical device created by a Minnesota company. In this warning, the FDA warns doctors and consumers about possible issues with Endo International PLC's urological devices. These devices - similar to the vaginal mesh products that have subject to recalls and lawsuits - are mainly for males with urological issues.

The FDA warns that the company has failed to validate the process it uses to create these products. The FDA also warns that the company has not done enough risk analysis on the design of the products to ensure that they work how they are designed. Finally, the FDA says that the company has been too slow in responding to complaints about the products with preventative and corrective changes.

While the FDA is willing to fine the company if these violations are not resolved, this type of action will not help people who are hurt by the products that are already in use. Consumers need to be able to trust that companies are doing everything they can to keep their products free of defects in both the design and manufacturing stages.


When companies fail to address design defects, manufacturing defects and other issues, people will get hurt. In these cases, Minnesota residents should understand their legal rights. Compensation could be available to those hurt by a defective product.

Source: Drug Watch, "Inspection Triggers FDA Warning for Mesh Manufacturer," Jennifer Mesko, April 23, 2014

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