Medical Device Injuries

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

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.

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.

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.

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

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.” …

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 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 …

ThermiVa is a type of device used in procedures some women undergo in order to address complications they have in their most intimate of regions. ThermiVa is a non-invasive, non-hormonal treatment that uses controlled radiofrequency …