09192017Headline:

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Steven Davis

Power Morcellator Claim Alleging Medical Malpractice Filed in NJ District Court

The FDA has revised its assessment of the cancer risk associated with morcellation, estimating that one in every 350 women who undergoes a hysterectomy for fibroids has an undetectable cancer that could be spread by morcellation.

Steven Davis

FBI Investigating Hazards of Power Morcellators

The FBI is currently investigating the power morcellator, a controversial surgical tool that has been alleged to spread dangerous uterine cancers in women during gynecological procedures. According to a May 27 report in the Wall Street Journal, three individuals have […]

Jacob Plattenberger

Don’t be fooled by the Pamphlets – Ethicon Pelvic Floor Systems Have Been Pulled from the Market

Prompted by the prospect of more litigation, Johnson & Johnson’s Ethicon unit told a federal judge in West Virginia it intends to stop marketing four vaginal mesh implant systems as a…

Jacob Plattenberger

Vaginal Mesh & FDA 510(k): Copycat Killers and the Dangers Within the System

The FDA has allowed the manufacturers of polypropelene transvaginal mesh and other devices to enter the US marketplace with very few safety checks. Congress is taking some important steps toward…

Jacob Plattenberger

J&J’s Gynecare Prolift marketed for 3 years without FDA approval

A new report published by Newsinferno recently revealed that Johnson & Johnson marketed their Gynecare Prolift device for three years before the FDA approved its use. Johnson & Johnson…

John M. Restaino DPM, JD, MPH

Experts in England Call for Complete Ban of Metal-on-Metal Implants

Experts in England found “unequivocal evidence” of high failure rates in metal-on-metal hip implants leading them to call for a complete ban of such implants. In a study published…

Tor Hoerman

FDA Considering Reclassification of Mesh as “High Risk”

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue – specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI). It is made from…

Tor Hoerman

FDA Acts on Vaginal Mesh Complications – Where are the Manufacturers?

It appears that news of the complications arising from Vaginal Mesh Kits has prompted the FDA to take action, with meetings scheduled regarding the safety of the kits taking place next week. This is…

Jacob Plattenberger

Infuse Bone Graft Study Questioned

Medtronic, Inc., based in Minneapolis, Minnesota, is the world’s largest medical technology company. Recently Medtronic came under fire after independent researchers questioned the safety…

Tor Hoerman

Who is Monitoring The Safety of Vaginal Mesh Kits?

Approximately 7 years ago, vaginal mesh kits were introduced to the market in an attempt to obtain the benefits of a more durable repair as well as to simplify and standardize the technique of mesh…