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Amber Scott
Amber Scott
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Transvaginal mesh and the FDA's 501(k) program: double trouble

8 comments

In this month’s issue of Trial magazine, the American Association for Justice exposes important health concerns surrounding transvaginal mesh, a device surgically implanted to reinforce damaged or weakened pelvic walls caused by stress urinary incontinence (SUI) or pelvic organ prolapse (POP).

In 1996, the Food and Drug Administration approved Boston Scientific Corp.’s ProteGen mesh to treat stress urinary incontinence, which MedlinePlus defines as accidentally urinating while working out, coughing, sneezing, or laughing due to weakened pelvic walls. Johnson & Johnson’s Gynecare TVT mesh was approved two years later and as of 2010, more than 168 surgical mesh implants were approved. This was largely due to the FDA’s special approval process known as the 510(k) program, which classifies certain devices, such as surgical mesh, into low or moderate risk categories.

The 510(k) program was introduced in the late 1970s when Congress passed the Medical Device Amendments, which defined the steps the FDA has to follow in order to approve devices. Manufacturers are granted permission to begin selling their device without the need to conduct clinical studies as long as there is a similar device on the market and provided the manufacturer gives the FDA 90 days’ notice.

Due to such a lenient approval process, surgical mesh made its way into more than 300,000 surgeries as of 2010. However, the implants have been shown to cause more harm than good, leading to thousands of lawsuits against Johnson & Johnson, Ethicon, and other manufacturers.

Several reports say the devices lower a woman’s quality of life due to infection, bleeding, urinary problems, mesh contractions, organ perforation, and mesh erosion through the vagina. Because the implants are meant to be permanent, women need to go through extensive and numerous surgeries to find and remove the mesh.

In 2011, the FDA issued a notification stating that the number of reported complications is not rare and that they have not seen evidence to prove that surgical mesh is more effective than alternatives in treating stress urinary incontinence and pelvic organ prolapse.

The American College of Obstetricians and Gynecologists says that surgical mesh should be further tested for safety and used only as an experiment in clinical trials until its safety is proven.

The FDA’s 510(k) approval process continues to cause controversy among critics who some feel the program should be eliminated altogether. What do you think? Should companies be able to sell medical devices that are kind of like something else another company is selling? Or do you think they should have to prove the merits of their own product before selling it? Express your opinions in the comment section below.

8 Comments

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  1. Christine Asprey says:
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    Hi, I’m a victim of Transvaginal mesh. Since the implant i’ve had infecions,complacations a second surgery and I’m having the most horrible pain one can imagine. Theres hardly any help, I truly fell alone and have no where to turn please help.I’m from Canada and was told there are no Doctors here to remove the mesh.

    Thanks
    Christine

  2. Noreen Wideman says:
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    I’m another Canadian victim of transvaginal mesh who had one hell of a painful time convincing doctors my mesh was eroding into my bladder and urethra besides out my vagina in tiny pieces. Only when I showed them the blue TVT fibers in my urine did they realize the extent of damage done in 8 months while they bounced me between doctors not knowing that the mesh really did have to be removed. Now 6 months post mesh removal I am in chronic pain from pudendal nerve damage. Foreign body response to the mesh caused deteriorating health from the time it was implanted in 2008, until the time it was removed in 2011. There are Canadian doctors to remove mesh,but they are scarce and hard to locate. for Canadian women we have a facebook page Canadian Victims of Transvaginal Mesh where we have compiled research for women to share with their GPs and support each other through advocacy and knowledge we have gained through our painful collective experiences. The FDA process is flawed and has let thousands of women down as well as doctors who depended on approved licensing to guarantee a level of testing that proved with long term studies the safety of the medical implants they used to treat POP and SUI. A safety net of having any complications of any permanent medical implant being a compulsory reportable adverse event would provide an early warning system when permanent implant devices are causing an unacceptable amount of adverse life altering and life threatening complications.The two failures, failure to test properly, failure to report all complications has caused loss of life and loss of quality of life. This is unforgivable,as this catastrophe could have been avoided had due diligence been practiced.

  3. Amber says:
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    Dear Ms. Asprey:
    Thank you for reading and commenting. I’m really sorry to hear about your situation. You need to consult with a physician to address your medical concerns as soon as possible. You may also want to speak with an attorney in Canada. If you don’t know of one, please call our firm at 1-877-696-3303 and ask for William Eadie, who would be happy to refer you to a Canadian firm. In the meantime, if you haven’t already done so, you may also want to look into the Canadian Victims of Transvaginal Mesh Facebook page that Ms. Wideman referenced in her comment.
    -Amber

  4. Amber says:
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    Dear Ms. Wideman:
    Thank you for your comment. Like Ms. Asprey above, I’m so sorry to hear about the pain you’ve endured. I’m glad you found physicians who were able to help you; I’m also grateful to you for sharing that Facebook page, which may help a lot of other women.
    You, too, may want to speak with an attorney in Canada about your case. If you need help finding one, Mr. Eadie would be happy to provide a referral. Please feel free to call 877-696-3303 to speak with him.
    Please take care of yourself.
    -Amber

  5. Lyn says:
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    I got a mesh implant in 1997. My doctor has left the state, but another doctor put me under to check for cancer because I keep getting bladder infections. No cancer thank God, but I would love to get relief from constant bladder infections before it turns into something more serious. Is there a law firm in the Cleveland/Parma, Ohio area working on a class action lawsuit regarding mesh implants?

  6. Lyn says:
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    I got a mesh implant in 1997. My doctor has left the state, but another doctor put me under to check for cancer because I keep getting bladder infections. No cancer thank God, but I would love to get relief from constant bladder infections before it turns into something more serious. Is there a law firm in the Cleveland/Parma, Ohio area working on a class action lawsuit regarding mesh implants?

  7. Lyn says:
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    I got a mesh implant in 1997. My doctor has left the state, but another doctor put me under to check for cancer because I keep getting bladder infections. No cancer thank God, but I would love to get relief from constant bladder infections before it turns into something more serious. Is there a law firm in the Cleveland/Parma, Ohio area working on a class action lawsuit regarding mesh implants?

  8. Amber Scott says:
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    Hi, Lyn:
    Please feel free to call us here at Spangenberg Shibley & Liber. We’re a Cleveland firm; our number is 216.696.3232. Please ask for Lauren Wargo.
    Thank you and best of luck to you.