Surgical Procedure Prompts Second Government Warning

By Robert Arnold - Investigative Reporter

HOUSTON - A common surgery for women has been plagued by lawsuits and government warnings.

In a small downtown conference room, four women gathered to share a common story of pain and altered lives. Each woman detailed what they described as severe complications from the use of medical mesh to treat a common problem.

Many women experience a condition called Pelvic Organ Prolapse, in which organs in the pelvic region begin to move or sag, triggering a number of problems including pain, incontinence and intimacy issues. This problem can be corrected through an invasive procedure that lifts and stitches the organs back in place. Another less-invasive procedure involves placing medical mesh to prop up and hold organs in place.

"No discussion, just that would be the best way to do it and easy," said Beatrice Santillan.

Santillan and three other women who spoke with Local 2 Investigates said none of their doctors told them there was an alternative to using mesh.

"She said, 'This is fine. We've done a lot of these in the past,'" said another woman who asked not to be identified. "So you feel OK. It's all right. She said, 'It's OK', and she's a doctor."

All four women said soon after having the mesh inserted, they began experiencing complications.

"It's changed everything. It's changed everything," said Janet Dotson, a former librarian. "The standing and lifting, I would just bleed, hurt, go home hurting. It just wasn't normal and it's still that way right now."

"I couldn't jump and run," said Janet Kramer, a physical education teacher. "I was an avid runner, I loved to run. Had to quit doing that and even to this day, I can't do it anymore."

"When I would sit down, it would feel like I was sitting on straight pins," said another woman. "I'm a seamstress and I can't sit down at a sewing machine and you're bleeding all the time, so you don't know what the problem is."

"Can't run with my kids. You know that's what I wanted -- to run with them, play basketball and volleyball, but I can't," said Santillan.

All four women said after months of complaining of problems, the mesh had to be removed. However, in all these cases, except for Kramer, the women said doctors could not remove all of the mesh.

"He told me, 'Look, I can't get to all of it. Some of it's in scar tissue,'" said one woman who recounted a conversation with her doctor regarding mesh removal. "'I can't guarantee you're not going to have any problems in the future.' He said, 'I can't guarantee that.'"

Santillan said she has lost all control of her bowel movements because of complications from mesh.

"I have to carry extra clothing wherever I go, " said Santillan.

Dotson said she has been told her entire bladder will have to be reconstructed.

"I don't have insurance so I don't know when I can have that done," said Dotson.

"Frequently, doctors can't get all the mesh out," said Georgia attorney Henry Garrard III.

Garrard said he represents 300 women in 34 states complaining of mesh-related complications. Garrard also represents the four women who spoke with Local 2.

"I have had doctors explain to me it's like picking little pieces of shattered glass out," said Garrard.

Lawsuits and government warnings contend the mesh moves, erodes and breaks apart once inside a woman's pelvis, making complete removal of the product difficult.

"Most of the time (doctors) have to take out tissue," said Garrard. "When they put it back together, you can't put it back like God made it."

Garrard represents women suing the leading manufacturer of medical mesh, New Jersey-based C.R. Bard. Local 2 tried several times to reach Bard officials via phone and email, but received no response.

"It's mostly surgical error," said Houston urogynecological surgeon Dr. Christopher Jayne. "It's mostly surgeon error."

Jayne contends mesh is not the problem and it is how the product is being inserted into the pelvic region.

"I think a lot of surgeons weren't taught properly or didn't understand exactly how to use this product," said Jayne. "You can't just assume because you are a master surgeon that you can do every surgery great, you have to get the training."

Jayne explained many times mesh is inserted through a "blind" procedure, meaning doctors "feel" where they are placing the mesh instead of traditional surgical methods where a doctor can see where they are placing the product. Jayne said he has performed approximately 100 mesh procedures over the last three years with no complications. Jayne added he has performed "far more" mesh removals and corrections that were performed by other surgeons.

"If this mesh is just a little off, you're more likely to have a complication," said Jayne.

Jayne also said he feels it was inappropriate that none of the women Local 2 spoke with were given information on alternate surgical procedures.

Jayne said he discusses all surgical options with his patients and even requires patients to sign a specific "VUI Vaginal Mesh Consent Form" that is separate from routine surgical consent forms. Jayne said patients should always ask about alternate procedures, ask doctors how many of these surgeries they have performed, what their specific complication rate is, what training they received for a specific procedure and who they would recommend for a second opinion.

"No surgeon who is worth their salt will be intimidated by these questions," said Jayne.

The anger is not solely directed at the manufacturers of mesh. The women Local 2 spoke with are also angry with the U.S. Food and Drug Administration.

The FDA cleared medical mesh to be marketed to patients through what is called a 510(k) approval process. Garrard said mesh is considered a Class II medical device and the FDA's approval process is "largely bureaucratic."

"The FDA does not require clinical studies," said Garrard. "It's a clearance process to clear the product, but the FDA will tell you specifically they have not done a study of the safety of the product."

Now, twice in three years, the FDA issued warnings about the use of medical mesh. The FDA reported receiving more than 3,500 reports of women having severe problems from mesh. In a "safety communication" issued by the FDA on July 13, officials wrote surgical placement of mesh through the vagina "may expose patients to greater risk than other surgical options."

The communication further stated, "there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries." The communication also stated the FDA is putting together an outside panel of experts in obstetrics and gynecology to discuss the "safety and effectiveness" of surgical mesh to treat Pelvic Organ Prolapse. The panel is scheduled to meet Sept. 8 and 9.

Women who claim they are suffering from mesh-related complications said the warning is a slap in their faces.

"It was cleared for market. It should have been cleared for our bodies at the same time, but it wasn't," said Dotson. "Now we have to pay for it."

Local 2 also contacted three other manufacturers of medical mesh regarding the FDA's communication -- Ethicon, a division of Johnson and Johnson, Boston Scientific and American Medical Systems.

Ethicon sent a statement, "Our primary concern is patient safety. Accordingly, we support the FDA?s efforts to review and assess data regarding the safety and efficacy of surgical mesh products. The use of mesh in surgical repair to treat conditions such as pelvic organ prolapse is an important option for many patients. Numerous clinical studies suggest that when combined with proper surgical technique, the use of mesh kits is efficacious and has an acceptable post-operative complication rate. All surgeries for treating these conditions have risks of complications. Potential complications and risks are disclosed in our product labeling and discussed in our professional education and promotional literature. It is important for physicians and patients to discuss the potential risks and benefits prior to surgery. Our devices are among the most studied devices on the market for these conditions. We are committed to supporting the use of mesh in surgical repair with clinical evidence, through investigator-initiated and company-sponsored clinical trials of our mesh products."

Boston Scientific sent the following statement.

"Boston Scientific believes that transvaginal placement of mesh to treat Pelvic Organ Prolapse (POP) and stress urinary incontinence (SUI) is and remains an important treatment option for patients. As part of its commitment to providing high quality and safe products to its customers and their patients, Boston Scientific will continue to work with the FDA to ensure that the appropriate information is provided to physicians and their patients - along with any new and additional information ? so they can make fully informed decisions regarding these treatment options. "

AMS did not respond to Local 2's request for comment.

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