Medical Device Injuries

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FDA May Release Hundreds of Thousands of Adverse Event Reports to The Public

In a sharp reversal of tone from our previous article titled, “FDA Hides Millions of Adverse Reports,” outgoing FDA Commissioner Dr. Scott Gottlieb ‘tweeted’ (in part) that the agency tasked with protecting Americans from dangerous

FDA Hides Millions of Adverse Reports

For the last 20 years, the FDA has been filing thousands of device failure reports from the public under an exemption program for manufacturers.

Bard Withdraws Women’s Hernia Mesh from EU Market

Bard announced it would be withdrawing its controversial women’s hernia mesh implantation devices from the European market.

Bone Cement Lawsuit

Certain cement used in knee replacement surgery has caused many Americans to undergo revision surgery, as the cement fails to stay bonded to the bone.

NeuroBlate Recall Lawsuit

A Class I recall was issued on the NeuroBlate system as it could pose serious injury or death from its probe overheating during procedures on the brain.

Getinge/Maquet IABP Recall Lawsuit

A worldwide recall of a device used to pump blood to the heart was issued due to failure at high altitudes, which could lead to serious injury or death.

Zimmer Bone Growth Stimulator Recall Lawsuit

The FDA has issued a Class I recall on over 1,300 Zimmer bone growth stimulators due to the potential for major health complications.

FormaV and FractoraV Vaginal Rejuvenation Lawsuit
If you or a loved one have suffered compilations after undergoing a vaginal rejuvenation procedure, the lawyers at Johnson // Becker can help.

FormaV and FractoraV Vaginal Rejuvenation Lawsuit

Manufactured by Inmode MD Ltd., FormaV and FractoraV lasers were targeted by the U.S. Food and Drug Administration recently for claims they can be used to treat “sexual dysfunction, vaginal rejuvenation and urinary stress incontinence.”

Exilis Ultra 360 Vaginal Rejuvenation Lawsuit

Exilis Ultra 360 Vaginal Rejuvenation Lawsuit

The Exilis Ultra 360 System is a type of device used for “vaginal rejuvenation” to treat rhytids and wrinkles. The Exilis Ultra 360 is manufactured by BTL Industries, Inc. and has been marketed to treat

Monalisa Touch Vaginal Rejuvenation Lawsuit

Monalisa Touch Laser Vaginal Rejuvenation Lawsuit

Monalisa Touch is one of the brands the U.S. Food and Drug recently called out in an effort to combat the misuse of energy-based devices as a means for “vaginal rejuvenation.” Monalisa Touch is a