Imagine going into the hospital for a routine surgery, but then developing complications that will change your life.
Teresa Sawyer says the procedure that has devastated hers actually affects thousands of women suffering similar problems from the same surgery -- and she's taking a stand.
"The only way I can do anything - stop it - is to stand up and say, 'stop putting it in women,'" she says.
Teresa and husband David's dream house is only half-finished and they are behind on payments. They bought the house and started renovations in 2010, but everything stopped after she went into the hospital to have what they were told would be a routine surgery.
"She would be back up and going in just a few days. That it would be a real quick process. That's what we were told and that was four surgeries ago," says David Sawyer.
But it was not one easy surgery.
Teresa had a transvaginal mesh device surgically implanted that is supposed to treat incontinence. The Food and Drug Administration confirmed more than 2,800 cases like hers, where a woman's body rejected the mesh from the device and caused the patient to develop complications.
The FDA held hearings last fall about the devices, but one doctor who testified thought the hearings were days late and dollars short.
"Fourteen years ago, or whatever it was, when I was approached by the industry and told to start implanting these devices I said, ‘No. I will not do this. This violates core basic surgical tenets,'" explained Surgeon Doctor Tom Margolis.
Margolis said this surgical procedure should never have been approved in the first place because it requires inserting the device through the vagina, which is not a sterile surgical environment. He believes there is no way to prevent the mesh from becoming contaminated and falling apart.
"The proponents of mesh have shown that there's erosion at a rate of 15.6 percent, and that's magnificently high -- and I'm not using magnificently in a good context," said Margolis. "That's an insanely, suicidally high complication rate."
That is exactly what happened to Teresa. In addition to the surgeries, she lives a life filled with pain.
So why is this mesh allowed if there is such a high rate of erosion? Why was Teresa Sawyer not given any warning of the dangers of the surgery?
One major issue is the FDA's approval system.
According to the hearing transcript, the FDA admitted studies were never done to see if surgical mesh implants were safe before the procedure was approved, caused by an FDA policy that has been in place for more than 30 years.
The policy basically states that if a company says a new medical product is virtually the same as a product already tested and on the market, the new product does not need the same testing.
Margolis believes another reason, in this particular case, it has taken so long to make people aware of the dangers is because the manufacturers and some doctors make a great profit off this type of surgery.
Note: As industry modified surgical mesh for these indications, none of the meshes were evaluated with original clinical data. Rather, the regulatory pathway was through the 510(k) or substantial equivalence pathway.
"Industry has hired proponent doctors to champion their cause in writing and in public forums have not necessarily been up front about the complications they've had," explained Margolis.
As a result of the hearings, the FDA recommended the manufacturers do extensive testing. For now, the mesh devices will stay on the market.
Teresa waits for the day when no other woman goes through what she did.
"The day that they actually do something is going to be a great celebration for a lot of women," she says.
A celebration that will not help her heal, but will make her feel that her pain is more worthwhile.
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