A Camano Island woman has filed a federal lawsuit claiming a recalled reflux device implanted in her body was defective and forced her to undergo another surgery, according to court records.
Janett Wingett, who lives on Camano Island, filed the lawsuit Tuesday in the U.S. District Court for the District of Minnesota against Torax Medical, Inc. and Ethicon, Inc.
She says the companies manufactured a defective LINX Reflux Management System that was implanted to treat her gastroesophageal reflux disease, or GERD.
The LINX device is a small ring made of titanium beads connected by wire.
Surgeons place it around the lower part of the esophagus to help prevent stomach acid from flowing back up, which causes heartburn and other GERD symptoms.
Because it is implanted through surgery, the device must meet strict federal standards before it can be sold and used in patients.
The lawsuit says the LINX received pre-market approval from the Food and Drug Administration in March 2012 and is considered a “restricted” device, meaning it is subject to detailed manufacturing and safety rules.
According to the complaint, Torax initiated a recall on May 31, 2018, after becoming aware of what it described as “an out of specification condition.”
The lawsuit says that issue could allow “a bead component to separate from an adjacent wire link,” causing the normally closed ring to come apart.
If that happens, the device can become “discontinuous and open,” the complaint states.
FDA records cited in the lawsuit show that 9,131 LINX devices were in the marketplace as of May 2018.
Wingett had her LINX implanted on Aug. 29, 2018, and the complaint says her device was subject to that recall.
She later had the device removed on Dec. 17, 2025.
In the lawsuit, Wingett alleges the device implanted in her was defectively manufactured and failed because it did not meet approved manufacturing specifications.
She claims the companies violated multiple federal regulations tied to quality control, production processes, inspection and testing, and preventing defective products from entering the market.
The complaint says she experienced a “severe recurrence” of her GERD symptoms and had to undergo another invasive surgery to remove the defective device.
Wingett is seeking more than $75,000 in damages.
She is also asking for compensation for past and future medical expenses, lost wages, physical pain and suffering, mental anguish, physical impairment and disfigurement.
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