“Thank You God. We can finally get the word out to women.”
Those are the words of Christine Scott, 53, a former runner who had a vaginal mesh implant to treat stress urinary incontinence in 2008. After that her health went downhill as the synthetic mesh eroded into her colon.
KGET-TV 17 in Bakersfield reported late Monday night (here) that the Bakersfield woman won a $5.5 million lawsuit she filed against mesh maker C.R. Bard. In the product liability action, Scott said she had the Avaulta Plus Biosynthetic Support System to correct some urine leakage, but it left her in chronic pain, incontinent, and unable to have intercourse.
“I don’t know if I have one or 100 surgeries ahead,” she said to the tv station.
The jury returned the verdict late Friday in Kern County Superior Court before Judge William Palmer. Scott told jurors she could only urinate with a catheter for five months. She then had to undergo eight additional removal surgeries. The Avaulta remains in her body as many surgeons feel the permanent implants cannot be safely removed.
The jury awarded Scot $5 million and her husband $500,000 for the loss of their relationship.
The lawsuit is a landmark victory and the first of its kind in the nation against a major mesh manufacturer. There are another 650 mesh cases pending against C.R. Bard and thousands pending against five other mesh manufacturers consolidated in multidistrict litigation.
Tested on Rabbits and Sheep
Attorney Elaine Houghton said, “ They tested this on they tested 16 rats 12 rabbits 4 sheep and by their own research the next living product this went into was a women.”
Houghton and her law partner, Gene Lorenz represented Scott.
KGET reports Bard stopped selling the Avaulta medical device on July 1, 2012 in the United States because the FDA wanted more clinical trials done.
The Bakersfield woman said the hardest part was having to keep quiet watching women continue to be hurt. In 2010 an estimated 200,000 women had synthetic mesh implanted to treat stress urinary incontinence. The actual complication rate is unknown since the U.S. does not monitor medical devices after they are implanted.
Synthetic meshes used to treat incontinence are petroleum-based polypropylene. They are considered a Class II medical device and manufacturers are not required to conduct clinical trials for safety and efficacy before they are marketed.
When I got that verdict it was, Thank you God. Now we can do something,” said Scott.
FDA- Complications “Not Rare”
Scott filed a lawsuit against Bard and her doctor in January, 2009. In October 2008, the U.S. Food and Drug Administration filed the first of two Safety Notifications warning the public that there was a degree of “rare” but “serious” complication association with mesh placement in some women. One year ago, the federal agency revised that notification and said that complications were “not rare.”
Many doctors have assumed that the FDA warnings primarily focus on synthetic transvaginal mesh for pelvic organ prolapse, not incontinence. This judgment flies in the face of that assumption.
Scott says she will start a support group. Patient Right to Know.org for people who have questions about surgical mesh.
C.R. Bard of Murray Hill, New Jersey plans to appeal. The Avaulta Plus is no longer sold in the U.S. but is sold globally. #