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Mesh Misery Update: Tucson doctors defend the use of surgical mesh
Mesh Misery Update: Tucson doctors defend the use of surgical mesh Video by kgun9.comvideo
Reporter: Valerie Cavazos
TUCSON (KGUN9-TV) -- It's a pain many women say is too much to bear and they blame a simple medical device for all their misery -- surgical mesh.
9OYS first told viewers about the controversy surrounding this seemingly harmless device back in May, but now some Tucson doctors are stepping forward to defend it.
63-year-old Beatrice Borquez, a patient, first explains why mesh has helped change her life. She says she lived in agony for years -- suffering from pelvic organ prolapse, a condition many women have after multiple births, menopause or weight gain.
"It felt like a baseball was coming out of my vagina. And it was awful," she said. "I couldn't sit, I could stand, I couldn't walk. And every time I moved and coughed I would urinate."
KGUN 9's Valerie Cavazos asked Borquez if she could describe the pain to something. 'I would have had given birth instead of that, you know," she said.
To relieve the excrutiating pain, her former doctor recommended a common surgery using biological tissue to fix it, but it failed. "It didn't work. It just came back down and it came back down worse."
Frustrated and miserable, she sought a specialist who stopped the pain -- using mesh. She said, "I've had a good time after that."
It's the same medical device that was approved by the FDA and sold as a simple kit that any doctor can use. Dr. Susan Kalota, a urologist, has used surgical mesh for years and was part of the Food and Drug Administration's 510 K approval process for the mesh devices. Since it has been successful in hernia repairs, she said the FDA thought mesh would solve similar prolapse problems in women.
"So the 510K made it that it was authorized with the understanding that it was similar to things on the market," said Dr. Kalota.
But Dr. Manuel Arreguin, a gynecologist, said the FDA didn't anticipate that the manufacturers would push the products as simple kids that don't require a specialist. He said, "I think they were absolutely sold that way. This is an easy procedure. You're already doing surgery in that space so just use this mesh. Put it in there -- not only will you be able to bill a little more -- but you'll see the results are much better."
Or much worse. Dr. Kalota said many specialists have since learned that mesh isn't for every patient. "In someone who's got less significant prolapse -- the mesh can be a nightmare." After receiving more than a thousand complaints, the FDA sent letters to the 35 manufacturers of the devices ordering new safety studies.
"So the FDA is not saying these are bad devices, they're saying that they are not as similar as was felt and that research needs to be done."
Last month, one of the biggest manufactures of surgical mesh, Johnson and Johnson, announced that it was phasing out its product. Now, Dr. Arrequin and Dr. Kalota are worred more manufacturers will follow suit.
Dr. Arrequin said, "Some of the negative results we're seeing is because the doctor has chosen an improper patient - maybe using mesh when they didn't have necessary training. So meshes do have a place because there is a way to repair women correctly."
Dr. Kalota added, "It would be very sad to lose it from the market because there are candidates that it really makes a difference." Candidates -- like Beatrice Borquez.
Cavazos asked Borquez about her thoughts on the complications with mesh. She replied, "I think they're overdoing it. I think it depends on who you talk to really. I mean I've had no problems."
The surgical mesh problem is behind a new trend at the FDA to give medical devices more scrutiny. KGUN 9 will stay on top of this issue and inform viewers of any new developments.