Recently in Transvaginal Mesh Category

January 10, 2012

F.D.A. Orders More Studies On The Risks Associated With Transvaginal Mesh

As anticipated, last week the Food and Drug Administration (FDA) issued an order requiring more studies on the risks of transvaginal mesh by manufacturers. Transvaginal mesh - also referred to as vaginal mesh and pelvic mesh - has come under fire after years of reports linking serious injuries to the devices. In September, an F.D.A. advisory panel recommended that such studies be required.

Transvaginal mesh is a medical device primarily used to treat pelvic organ prolapse and stress urinary incontinence. Over the years, significant problems have been reported to the FDA including:

• Vaginal mesh hardening
• Infection
• Vaginal pain
• Vaginal mesh erosion, protrusion and extrusion through the vagina
• Organ injury
• Pain during intercourse

If you or a loved one has had surgery utilizing the transvaginal mesh and experienced injuries, it's important to speak with an experienced New Mexico products liability attorney who is familiar with vaginal mesh complications.

The FDA first reported problems with the mesh in 2008, but stated that such problems were rare. However, in the time span from 2008 to 2010, the increase in adverse events related to the mesh increased 10-fold, leading to the most recent warnings. According to reports, in 2010 about 185,000 women underwent treatments using the medical device and about 15% of those women treated with vaginal mesh experienced complications. A study published in the journal Obstetrics and Gynecology also determined that the mesh did not provide any greater benefits than the traditional method using a patient's own ligaments.

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November 30, 2011

Joint Commission Makes Recommendations On Use Of Transvaginal Mesh

A recent report issued jointly by the American College of Obstetricians and the American Urogynecologic Society details vaginal mesh recommendations, including that the mesh should only be used for certain high-risk women. The safety and efficacy of the synthetic mesh, also known as transvaginal mesh or bladder mesh, has been called in question, making its use only beneficial for a small percentage of women where the benefits outweigh the risks.

Vaginal mesh has been used for the treatment of pelvic organ prolapse, condition where the pelvic muscles become torn or stretching, causing the pelvic organs to "drop down and bulge" into the vagina. More the 350,000 women have surgery to correct this problem each year. In the past, vaginal mesh has been used to repair POP. However studies have shown that the mesh has cause serious complications such as pain, infection, and protrusion through the vagina, often necessitating additional surgeries. In fact, according to one report "a small but significant group experience permanent and life-altering problems, including pelvic pain and painful sexual intercourse because the mesh erodes through the vagina wall."

If you or a loved one has had surgery implanting the vaginal mesh and experienced complications, it is important to consult with an experienced transvaginal mesh attorney. Those injured as the result of this dangerous medical device may be entitled to compensation for their harm. A knowledgeable transvaginal mesh lawyer can advise you concerning your rights and provide critical guidance about your next steps.

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October 30, 2011

Transvaginal Mesh Device Based On Recalled Product

As women across the country continue to suffer complications from the use of Johnson & Johnson's transvaginal mesh devices, a new report reveals that the design of the bladder mesh was based on recalled transvaginal mesh devices that had been taken off the market more than ten years ago due to safety problems. The devices were designed to treat a condition called pelvic organ prolapse.

Transvaginal mesh, also referred to as a pelvic sling or bladder mesh - has been subject to increased scrutiny as the result of problems from its use including:

• Infection
• Vaginal pain
• Injury to nearby organs
• Bladder perforations
• Vaginal mesh hardening

If you or someone you love has experienced complications from the use of transvaginal mesh, it is important to speak with an experienced defective medical device attorney who can provide critical advice concerning your injuries. In many circumstances, you may be entitled to monetary compensation.

Here, reports indicate that even though the FDA had pulled a similar mesh design created by Boston Scientific Corporation from the market, the FDA continued approving the similarly designed vaginal mesh created by Johnson & Johnson. Now, makers of the implant face more than 600 lawsuits nation wide from women who have suffered serious injuries from the devices. The devices were approved as part of FDA's 510(k) process that allows "fast-track" approval of medical devices where a similar device is already on the market. The fast-track process allows new devices to be approved with little - if any - testing on patients.

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October 12, 2011

Transvaginal Mesh Linked To Serious Side Effects And Complications

The FDA has recently issued an updated transvaginal mesh warning on the use of the mesh to help repair pelvic organ prolapse (POP). POP occurs when the pelvic organs fall out of place as the result of the stretching or weakening of the tissues holding the organs in place. Transvaginal mesh - also known as vaginal mesh, bladder mesh or a pelvic sling - has been used to surgical correct this condition. However, research has concluded that serious side effects and complications may result due to its use.

These side effects and risks include:

• Bladder perforation
• Pelvic hemorrhage
• Mesh erosion
• Infection
• Pain during intercourse
• Bleeding
• Incontinence

Although some of these effects may be reverse through additional surgeries, others may be life-long, debilitating consequences. According to the FDA - most cases of POP can be treated successfully without the use of transvaginal mesh. The implanting of this dangerous medical device unnecessarily exposes patients to the risk of harm.

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September 12, 2011

FDA Holds Hearings On Transvaginal Mesh

The FDA met last week to determine whether surgical mesh inserted surgically inserted into the vagina, also known as transvaginal mesh or pelvic mesh, needs tighter regulation by the FDA. The mesh is used to treat a painful condition called pelvic-organ prolapse. As the result of close to 3000 reports of adverse events, including seven deaths, the manufacturer - Johnson & Johnson now faces several lawsuits across the country.

Transvaginal mesh - like many other defective medical products - was allowed on the market as the result of an expedited regulatory process. The pelvic mesh is currently considered a Class II medical device and was allowed a quick entry into the market without preclinical testing if manufacturers were able to show that the devices is "substantially equivalent" to an existing device on the market.

The FDA is evaluating whether to change the classification of the transvaginal mesh to Class III - high risk. If the FDA changes the rating, the pelvic mesh would require additional testing and be subject to a longer approval period.

Based on initial reports of the transvaginal mesh hearings, it appears that the advisory committee is in favor of stricter testing requirements. A number of risks are associated with the mesh, including organ perforation and bleeding, long-term mesh exposure to the bladder, vagina and rectum, pain and infection, urinary problems, as well as the need for additional revision surgeries. Several reports also indicated that the use of the mesh exposes patients to "unnecessary risk without a benefit above safer options."

As New Mexico transvaginal mesh lawyers, we support tougher regulations. Too often innocent patients are injured due to defective medical devices that are rushed to market.

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September 2, 2011

FDA Warns Of Risks Associated With Transvaginal Mesh

Recently the FDA issued a transvaginal mesh warning concerning the use of the medical device (also known as pelvic mesh, pelvic sling or bladder mesh) as a method to repair pelvic organ prolapse. The FDA warning stated that using transvaginal mesh to repair pelvic organ prolapse exposes patients to an "unnecessary risk" without providing any benefit above safer measures. Next week, the FDA will conduct hearings to determine whether stricter safety measures or a possible recall of the transvaginal mesh is necessary.

Problems from the medical device include pain, bleeding, infection, injury to nearby organ, and protrusion of the mesh through the vagina.

If you have undergone surgery for pelvic organ prolapse and surgeons used the pelvic mesh, it is important to consult with a transvaginal mesh attorney regarding your next steps.

According to an FDA representative, "There are clear risks associated with the transvaginal placement of mesh...The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh." This warning came after the FDA received reports of 1503 adverse events from 2008 to 2010.

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