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PELVIC MESH

Why Pelvic Mesh is Hazardous to Womens' Health

The Story on Pelvic Mesh Injuries and Illness
Pelvic mesh was first introduced in 1998 to alleviate pelvic organ prolapse,(POP) in women which causes
stress urinary incontinence—in other words, urine leakage when a woman laughs, sneezes or coughs.
Another problem caused by POP is that the bladder becomes weak and actually falls a bit. Pelvic mesh
also acts like a sling, holding the bladder in its correct position.

Pelvic mesh is also known as transvaginal mesh, gynecological mesh or mesh slings. When pelvic mesh
began being widely used, it was thought to be a safe and effective treatment for POP. The device is
made of a type of plastic called polypropylene and inserted into the vaginal wall. It is estimated that 3 to
4 million women globally have pelvic mesh implants and that 5 percent, or 150,000 to 200,000
of them are suffering from complications caused by this device. As of this writing more than 100,000
product liability lawsuits have been filed against the manufacturers of pelvic mesh implants including
Ethicon, a division of Johnson & Johnson, C.R. Bard and Boston Scientific.

Doctors that have removed pelvic mesh from patients discovered that in many cases the mesh was
shrunken, hardened and encased in scar tissue. The injuries and illnesses resulting from pelvic mesh are
a byproduct of the mesh eroding through the skin and tissue, right through the vaginal wall itself. This
causes vaginal bleeding, infections, discharge and painful intercourse. Injury to the vagina, bladder and
surrounding blood vessels may also result when the mesh migrates outside the vaginal wall. Injuries to
women’s sexual partners have also been reported.

Pelvic Mesh Symptoms and Complications
Women who have been harmed by or have died from pelvic mesh have reported a wide range of
medical complications such as:

Lawsuits
A huge number of product liability lawsuits seeking compensatory and punitive damages on behalf of
women have been filed over the years. Specific liabilities included defective design, strict liability for
failure to warn and negligence on the part of the manufacturers and marketers.

The most recent and significant cases include:

January 31, 2019
Ethicon/Johnson & Johnson
Emmett v Ethicon
$41 million awarded by a Philadelphia jury to Suzanne Emmett

April 2018
C.R. Bard
Mary McGinnis v C.R. Bard, Inc.
$68 million in NJ jury trial
The first bellwether trial as part of New Jersey’s mass tort program

August 2017
Endo International
Additional $775 million —totals $2.6 billion in settlement funds

October 2016
Boston Scientific
$14.3 million awarded to three women in a jury trial
2015: $457 million settlement for 6,000 lawsuits

Current Status of Pelvic Mesh
Although pelvic mesh has been used in the U.S. since 1998, the FDA did not issue a warning until 2008
after receiving over 1,000 adverse event reports.

On April 16, 2019 the FDA finally ordered all pelvic mesh companies to stop selling and distributing their products. These companies, Boston Scientific and Coloplast have not proven that their pelvic mesh products are safe or effective. They were given 10 days to submit their product withdrawal plans to the FDA.

2011:

January 5, 2016

Outside the U.S.
Although the U.S. has not stopped its sales, pelvic mesh is banned in the U.K and Australia.

Resources
60 Minutes : Gynecological Mesh: The Medical Device That has 100,000 Women Suing
NPR: A Danger Within Us

Facebook Support Groups
Surgical Mesh Complication information
Mesh Me Not

Women who have been implanted with pelvic mesh can get detailed information about health issues and effects on the FDA website.



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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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