Unapproved Medical Device Causes Grave Injuries in Women

April 13, 2012 (Press-News.org) Unapproved Medical Device Causes Grave Injuries in Women

A middle-aged mother of three ended up in an emergency room after declaring she wanted to die to escape the pain caused by an implanted medical device -- a synthetic mesh used to support sagging organs in the pelvic area. The woman is not alone in her pain. More than 550 women have filed lawsuits against Johnson & Johnson for personal injuries allegedly sustained from the vaginal mesh implant.

Johnson & Johnson started selling the device in 2005 without receiving approval from the Food and Drug Administration. It was not until 2007 that the FDA even obtained knowledge of the medical device. In 2008, it approved the device based on data provided by JNJ but reclassified the device, and another like it, into a higher-risk category last year after seeing a five-fold increase in incidences of injury, malfunction and death with vaginal mesh implants.

Although many medical devices may be cleared for use without benefit of the FDA's rigorous approval process -- when the device is substantially the same as another approved device -- the FDA claims JNJ was wrong to put the mesh into distribution. This is not the first time JNJ has incurred the ire of the FDA; departments within JNJ recently pled guilty to illegally marketing drugs, and, in another matter, to bribery.

Implanted vaginal mesh is often used to treat pelvic organ sagging, which can be caused by childbirth or age. The mesh is supposed to strengthen weakened pelvic tissue, keeping the bladder and other organs from bulging into the vagina or causing urinary incontinence. For hundreds of women, however, the device caused more problems than it cured, leading to multiple hospitalizations in an attempt to correct the damage caused by the mesh. Some symptoms include:
-Infection
-Nerve damage
-Erosion of the mesh into the vaginal wall
-Inability to sit or stand without excruciating pain

The FDA is not infallible and some medical devices do not do what their manufacturers claim. However, in the medical field, health care providers and manufacturers must put the safety and health of patients first and must provide a full disclosure of any risks associated with a procedure or treatment.

If you are injured by a defective medical device or negligent care, you may be entitled to compensation for your losses, pain and suffering. Consult with an experienced lawyer who is knowledgeable about personal injuries and negligence.

Article provided by Law Office of Gary M. Freeman
Visit us at http://www.freemanattorney.com/