Please Note: Schmidt & Clark, LLP, is no longer accepting denture cream lawsuits. If you feel that you may have a potential case, we urge you to contact another law firm adequately suited to handle your case.
The announcement was reported by the Associated Press amid a growing number of lawsuits claiming that Zinc caused neurological damage and blood problems in denture cream users.
Poligrip® and Fixodent® are both popular denture adhesives used by millions of Americans. In fact, there are approximately 35 million denture wearers in the United States alone and doctors are beginning to wonder if there is a link between denture adhesives and a variety of serious health issues such as Zinc Poisoning, Hypocupremia, Hyperzincemia and Neuropathy.
What is the problem?
Resource Update: In 2008, the American Academy of Neurology published a study titled, “Denture Cream: An unusual source of excess zinc, leading to hypocupremia and neurologic disease.”
In the study the researchers concluded that, “Denture cream contains zinc, and chronic excessiveuse may result in hypocupremia and serious neurologic disease.”
News Update: Janet St. James with WFAA-TV has released another article titled, “More claims of denture cream poisoning.”
Recently, a man who had been using Super Poligrip for over eight years filed suit against GlaxoSmithKline, the manufacturers of the product. The plaintiff alleges that the undisclosed ingredient Zinc, in the denture cream has caused him permanent damage and that the denture cream has poisoned him.
The permanent damage is a nerve disorder called Neuropathy. Neuropathy is commonly diagnosed in people with diabetes, which the plaintiff is not.
Reported by News 8 in the Dallas/Fort Worth area, Doctors began to “think outside the box” when they could not determine what caused the man’s Neuropathy. After weeks of medical detective work, University of Texas Southwestern Dr. Bhushan discovered what he believed was wrong. “It was literally Zinc poisoning,” Bhushan said.
Zinc poisoning was at least what two doctors have linked to putting denture adhesives like Poligrip and Fixodent on dentures.
Like most denture adhesives, Poligrip doesn’t list ingredients on the label and the Food & Drug Administration does not require them to do so, as their product is classified as Class 1.
However, News 8 recently reported that they learned the denture paste does contain Zinc, which is used as an odor blocker and bonding agent.
In addition to being swallowed, Zinc can be absorbed through the skin or the gums. News 8 inquiries revealed another popular denture adhesive, Fixodent, also contained Zinc.
“With an estimated 35 million denture wearers in the United States alone, Dr. Bhushan now questions whether the case of zinc poisoning could be far more common and undiagnosed in the older population that typically wears dentures than believed.”
No government agency thus far has found any denture adhesive to be a health hazard.
The plaintiff is hoping that his case will at least result in warnings on labels.
“Even toothpaste has a poison control number,” he said. “This stuff has nothing whatsoever, no warnings, no ingredients, nothing.”
He’s been told the nerve damage he suffered from Zinc poisoning is permanent.
Source | WFAA-TV
“The U.S. Food and Drug Administration (FDA) regulates denture adhesives, which are medical devices under the Food, Drug and Cosmetic Act. A denture adhesive is a device intended to be applied to the base of a denture before the denture is inserted in a patient’s mouth to improve denture retention and comfort. FDA has classified this product as a low-risk device (class I). While manufacturers are not required to submit marketing applications to FDA for most class I devices, they still must register and list a class I device with the agency and comply with other applicable FDA requirements. These requirements include adverse event reporting, manufacturing controls, and labeling that is neither false nor misleading. FDA monitors adverse events from medical devices through mandatory and voluntary reporting systems. Manufacturers and hospitals are required by law to report deaths and serious injuries. Manufacturers also must report malfunctions that could result in death or serious injury. FDA reviews reports submitted to the agency and has authority to take immediate action, when warranted, to protect public health. Consumers can report problems experienced with any product to FDA either by phone (800-FDA-1088), fax (800-FDA-0178), on-line (www.fda.gov) or mail (MedWatch, The FDA Safety Information and Adverse Event Reporting Program, FDA, 5600 Fishers Lane, Rockville, MD 20852).”
Statement from GlaxoSmithKline Consumer Healthcare
Source | WFAA-TV
“GlaxoSmithKline Consumer Healthcare stands by the safety and efficacy of Super Poligrip®, which is approved and regulated by the Food and Drug Administration (FDA). Although we can’t comment on this person’s claim, we want to assure consumers that Super Poligrip is safe and effective when used as directed. When someone uses Super Poligrip for their dentures, the vast majority of the zinc in the product remains in the adhesive and is not released into the mouth. Thus the potential for absorption of zinc through the gums is minimal. Although it is expected that a small amount of Super Poligrip would be swallowed when used as directed, the amount of zinc that is released into the stomach and absorbed into the bloodstream is very small. Therefore, the possibility of experiencing adverse effects from exposure to zinc in Super Poligrip is highly unlikely when the product is used as directed. Zinc is an essential mineral that is found in almost every cell in the body and in foods like red meat, poultry, whole grains and beans and is necessary for the maintenance of good health and nutrition. Zinc is a very common ingredient in many over- the- counter and FDA approved products.”