It’s almost as if their bodies have become their enemies.
After having children and as they aged, organs shifted and some dropped so much that these women could feel them moving.
A mesh implant was marketed as a solution for supporting a bladder, uterus, vagina or rectum that has moved – a condition known as pelvic organ prolapse.
But, the women say, the fix has been more painful than the condition that initially led them to surgery.
Now they want the company that makes the Bard Avaulta “support system” to pay.
An Athens law firm has filed suits for at least 85 women against the maker of the product, C.R. Bard of New Jersey. Three of the most recent cases were entered in U.S. District Court in Atlanta three weeks ago. Lawyers nationwide have filed dozens of more lawsuits. The lawsuits are not asking for a specific amount, leaving it up to juries to determine the damages.
“They [women] get this product and then they wind up with intractable pain,” said Athens attorney Henry Garrard, whose firm has cases pending in 33 states and in Canada.
Garrard said this transvaginal mesh product has caused a plethora of problems, and most of them cannot be fixed.
Bard did not respond to telephone calls and emails sent over two days seeking comment.
“The mesh appears to be moving from where it was originally put,” Garrard told the AJC. “It curls, tearing nerves and doing significant damage. When they go in to try to repair it and take it out, they [surgeons] generally can’t get the arms [of the support system] out.”
The system is designed so surrounding tissue grows over the “arms” and that is supposed to hold the mesh and, consequently, the organ in place.
“When this thing goes bad and they try to take out the center portion … often they can’t get the arms out,” Garrard said. “It’s pain for the rest of their lives.”
Jane Pennington of Carrollton had to give up her wedding planning business soon after her first surgery two years ago; the pain and the frequent doctor and hospital visits made it impossible for her to work. She is now seeing a doctor in Texas who has become one of the nation’s few experts in removing the mesh. Her insurance does not cover the cost of multiple trips to Dallas.
Pennington, 62, first saw a doctor in March 2009, when her bladder prolapsed. She could feel the organ had moved but “it wasn’t painful,” Pennington told the AJC.
Pennington recalled that her doctor said she “needed surgery because I can’t go through life with an organ not where it’s supposed to be. The mesh looked like a good product. I did some research. I said ‘sounds like a great deal because it’s supposed to be permanent. I don’t have to worry about it again.”
She’s now had a total of four surgeries in the past two years. The most recent, last November, was to remove scar tissue and for “pelvic reconstruction.” For now, the “organs are holding where they are supposed to be … because of the scar tissue,” Pennington said.
“I’ll never get my life back as it was before, Pennington said. “I can’t believe I actually had something implanted in me that has done great, great harm to me and my family.”
The Internet is littered with postings from attorneys looking for clients who have had the Avaulta implanted.
In 2004 it was reported at the World Health Organization Third International Consultation on Incontinence that vaginal mesh had a high rate of complications.
Avaulta vaginal mesh was allowed on the U.S. market in 2005 after the U.S. Food and Drug Administration cleared it as “substantially equivalent to another legally marketed product.” Bard, which has a medical division in Covington, produces a device made of bio-synthetic material and two of its models have porcine coverings.
Then the FDA issued warnings in October 2008 and February 2009 about complications from mesh implanted to treat pelvic organ prolapse. The FDA did not name a manufacturer, only addressing problems with the mesh system.
Cindy Cowan of Marietta had the mesh implanted because her bladder prolapsed.
“In layman’s terms, my bladder was falling out,” said Cowan, 56.
She had surgery to remove the mesh in July 2008 and a second operation two weeks later.
“After that surgery, my husband and I never had intercourse again,” Cowan said.
Three years later, her bladder has begun to leak again.
Cowan said she considers herself luckier than other women who have had problems with the mesh, but still, “I don’t know what to expect in the future.”
Lynda Barner, 61, had surgery on Feb. 25, 2008, to have the Avaulta Plus system implanted to lift her pelvic floor, which includes the vagina, uterus, bladder and rectum.
“The surgery actually went very well,” said Barner of Hilton Head, S.C.
But she didn’t heal.
There was outpatient surgery in March. In July 2008 she underwent her third surgery that year, an hour-and-a-half-long operation at the Medical University of South Carolina in Charleston.
“The mesh had to be removed or I would never heal,” Barner said.
The doctors removed more mesh in May 2009. That operation lasted five hours, she said.
The pain in her pelvic area continued and moved to her back, legs and buttocks, and her sciatic nerve has been affected.
“I couldn’t have intercourse with my husband,” Barner said.
She said she also can no longer go boating or on bike rides with her husband. “It affected a lot of our relationship,” Barner said.
Her most recent surgery was on March 15, 2010, lasting more than five hours.
“I may be looking at another surgery,” Barner said recently. “I’m trying to make the best of this … But I feel I’m not the person I was. I wonder if this could end my marriage. I feel so inadequate. I feel I let him [her husband] down. It takes a toll on a marriage.”
About the Author
