Syracuse Injury Lawyer Blog

A Syracuse woman has filed a product liability lawsuit against Mentor Corporation, the manufacturer of ObTape – intended to combat stress urinary incontinence. Her doctor suggested that she undergo a simple procedure to plug the leak by surgically inserting a “sling” under her urethra.

After the procedure, the leakage stopped. However, the woman began experiencing a bloody vaginal discharge. It turns out that the discharge was caused by the sling, composed of a mesh-like material, was working its way through her vaginal wall. Since the sling penetrated the vaginal wall, the woman has undergone five operation to remove small pieces of the sling. Future surgery will be necessary.

Mentor Corporation was recently acquired by Johnson & Johnson. According to Mentor’s attorney, as reported in the New York Times, “[i]t’s very unfortunate when anyone reports a complication. That being said, these are complications that are well known, that patients are warned about, and are inherent to a surgical procedure that has helped thousands and thousands of people live a better life.”

Hundreds of adverse events associated with ObTape have been reported and lawsuits are cropping up around the country. Many experts believe that the ObTape sling was too dense and that it was rushed trough the F.D.A. approval process.
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New York State Senator Kirsten Gillibrand introduced legislation on Wednesday to protect Syracuse babies, and young children throughout the State of New York. The legislation, titled the Safe Baby Products Act, is intended to combat toxins and carcinogens in common products used on children, including shampoo and lotion. A recent report suggests that dozens of bath products, perhaps including those produced by Johnson & Johnson, may contain cancer-causing agents such as 1,4 dioxane and formaldehyde.

The Safe Baby Products Act will assist the Food and Drug Administration with investigations into chemicals found in foods and products. The results of the those investigations will also be public. According to Albany-based Gillibrand, “[t]he good news is we don’t know they’re bad yet. All we know is that they have trace amounts of these chemicals that are known probable human carcinogens and irritants, and so we need to have the FDA do the test and tell us, are these levels safe, are these products safe, and do we have to worry.”

Under the Safe Baby Products Act, if a product is deemed unsafe, the FDA will have the power to create manufacturing guidelines to prevent dangerous products from harming young children.
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The Food and Drug Administration announced on Thursday to doctors around the country, including those purchasing and administering Botox in Syracuse and Central New York, that stronger product injury warnings must accompany Botox.

The FDA has instructed producers of Botox to ensure that boxes of the neurotoxin warn of the risk of side effects which may spread far beyond intended paralysis at an injection site, including difficulty breathing, trouble swallowing and blurred vision. Since 1997, there have been more than 650 adverse reactions to Botox, including 16 deaths.

A black box warning is the FDA’s strongest warning and is intended to signify a significant risk of danger. Like it sounds, a black box warning is contained within a black box. White text contrasts with the black box to ensure maximum visibility. Products that must have a black box warning and risk evaluation and mitigation strategy include: Botox, (botulinum toxin type A), Botox Cosmetic (botulinum toxin type A), Myobloc (botulinum toxin type B), and Dysport (abobutulinum toxin A).
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