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On February 2, 2017, Rexina Mize and her husband Minh Nguyen filed a lawsuit against Mentor Worldwide LLC; Johnson & Johnson; Ethicon, Inc. in the Superior Court of California County of Los Angeles for the following:
- Negligence
- Failure to warn consumers about the dangers of the product
- Manufacturing defect
- Breach of implied warranty, and
- Loss of consortium, or damages suffered
The plaintiffs in the case allege that Mentor failed to warn consumers of known risks associated with the devices. Additionally, the plaintiffs allege the manufacturer failed to both follow an important six-part post-approval process required by the FDA. At least one other similar lawsuit has been filed against Mentor.