Vaginal Mesh and the Approval of Medical Devices

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vaginal mesh lawsuitsThese days, when we mention pelvic organ prolapse or stress urinary incontinence, people will always associate it to the use of vaginal mesh. After all, the device is almost always used to help these medical conditions. However, there are reports that say negative feedbacks about these meshes because some people have suffered from them. In short, it was found out that some manufactured vaginal mesh devices were defective and they had made many people file vaginal mesh lawsuits against manufacturers.

Now, under the Obama administration, a law has been passed doubling the fees for federal government approval of medical devices. This will benefit many people because defective medical devices may be avoided as more quality control measures may be instituted for medical products before they can be approved.

Read Full Story Here: FDA Releases Medical Device User Fee Schedule For 2013

Finding the Right Doctor to Address Urinary Incontinence

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What Is Stress Urinary Incontinence?A patient takes no delight telling a medical professional about incontinence symptoms, medical journals say, because it may cause embarrassment and anxiety. However, seeing a doctor is necessary for learning more about one’s symptoms and to request for the possible treatment of stress urinary incontinence. So how do you find the right doctor to address all your needs?

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The Use of TVM in POP and SUI

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Women in all sides of the world recognize the medical device trans-vaginal mesh (TVM). This medical instrument has been utilized by doctors in the surgical management of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), two medical conditions related to aging, by strengthening the foundation of the vaginal wall, reestablishing the normal appearance of the vagina, and alleviating sexual impairments. POP and SUI develop in older women, with no exception to race. The most at risk of developing these conditions are the women who have gone through menopause, hysterectomy, and childbirth.

Pelvic Organ Prolapse

Pelvic Organ Prolapse happens when the connective tissues that support the vaginal wall elongate and weaken. The primary factors that can damage the vaginal wall are old age, hysterectomy, and vaginal delivery.

There are different types of Pelvic Organ Prolapse, and the primary types are urethrocele, rectocele, and bladder and uterine prolapse. The most widespread of these types is bladder prolapse. This occurs when the bladder sticks out into the vaginal wall. Another type that can be related to this is urethrocele, i.e. when the urethra protrudes into the vaginal wall. Moreover, rectocele is the exposure of some parts of the rectum into the back wall of the vagina, and uterine prolapse is the sinking of the uterus into the vagina.

Stress Urinary Incontinence

Stress Urinary Incontinence is not one of the symptoms of POP. It may be defined as the uncontrolled escape of urine from the bladder during sudden movements like sneezing or coughing. The over-activity of the urethra as a result of damaged pelvic muscles is the most usual reason for this.

When was TVM first used?

Surgical mesh was introduced in 1950, and it was initially indicated as treatment for hernia. It was in 1950 that medical experts learned that it has a medical benefit for POP patients.And in 1990, it was successfully used by physicians trans-vaginally. And in 1990, the implantation of the mesh through the vagina was practiced. There are approximately 250,000 cases of TVM procedures recorded as of today.

Despite the fact that TVM surgery was not properly tested, it was introduced to be practiced because it favorably alleviated the symptoms of POP and SUI at first, and non-mesh procedures were not effective in several cases. But in recent years, complaints of serious complications caused by TVM surgery has climbed up and will continue to increase since TVM lawsuits multiply all over the United States.

References:

http://www.emedicinehealth.com/vaginal_prolapse/page2_em.htm

http://www.healthywomen.org/condition/pelvic-organ-prolapse

http://www.utilis.net/Morning%20Topics/Gynecology/Pelvic%20organ%20prolapse.pdf

http://www.usdrugrecall.com/category/medical-devices/transvaginal-mesh