Drug Recalls - TransVaginal Mesh

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TransVaginal Mesh Warning

Thursday, 04 August 2011 14:59 | Written by Drug Recall Lawyer |

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The FDA has warned of serious complications linked to TransVaginal Mesh. According to the FDA, the most serious side effects include vaginal mesh erosion, a serious and very painful complication that may lead to splitting of skin or tissue. Additional serious side effects from TransVaginal mesh include infection, pelvic organ prolapse, and urinary incontinence. Serious complications from vaginal mesh devices may be observed from almost a dozen different medical device manufacturers.

The dangerous side effects came to light in a clinical trial that was stopped after an unacceptable percentage of the women implanted with the vaginal mesh medical device suffered vaginal mesh erosion within a period of only three months of receiving the vaginal mesh device. According to one of the largest analyses of almost 12,000 women, about 10% of women experienced mesh erosion within a year after surgery. This figure includes both synthetic mesh and biologic types. Mesh problems tend to develop at least a month after surgery for POP as opposed to the immediate recovery period. The average time for an erosion of mesh to occur may vary by surgery.

What is Vaginal Mesh and what are the problems?

There are four types of surgical mesh: non-absorbable polyester or polypropylene, absorbable synthetics, animal tissues, and combinations of the above. Most GYN and female urology surgeries use the polyester or polypropylene type of mesh. Manufacturers are required to report adverse outcomes linked to their products. The FDA has recently disclosed 1,105 reports of possible problems with mesh used for prolapse repair, or for urinary stress incontinence surgery. In the last three years there have been an additional 2,874 adverse reports according to the FDA.

According to a just-published FDA report, the most common problems occurred when mesh was used for repair of prolapse:

Erosion or protrusion of the mesh from the soft tissues

Pain, including pain with intercourse

Infections in the area of the mesh

Urinary tract problems

Bleeding from the mesh site

Damage to nearby organs

TransVaginal mesh is a material that stretches across the vaginal wall providing support for damaged tissue and is one option for treatment of pelvic organ prolapse or stress urinary incontinence. These conditions are often the result of childbirth or pelvic surgery.

While implantation of this surgical mesh has proven to be an effective treatment for some patients, the FDA alerted consumers of possible complications to such treatment. Reports stated that 9 surgical mesh manufacturers had submitted over 1,000 reports over a three-year period, of postsurgical complications in patients that had undergone transvaginal placement of surgical mesh.

Perforation of the bowel, bladder and blood vessels were reported by many physicians, along with vaginal scarring and mesh erosion. The only symptoms of these conditions are significant pain and discomfort, however treatment can often be a great deal more serious.

Blood Transfusion, abscess drainage, intravenous therapy or additional surgery were all reported as modes of treatment. Although the FDA did determine causation or what factors placed certain patients at a higher risk for complication, many physician have speculated that age, the condition that necessitated the mesh, as well as estrogen levels were all possible indicators for risk of erosion.

If you have undergone transvaginal placement of surgical mesh and experience any discomfort seek the advice of your physician as it may be an indication of possible erosion of the material.

Last Updated (Thursday, 04 August 2011 16:25)

Drug Recalls - A Drug Safety Consumer Resource

Written by Drug Recall Writer

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Anybody who watches television, surfs the Internet or flips through a magazine is very familiar with advertising for pharmaceutical drugs picturing attractive, healthy and active people. Prescription and over the counter drugs are used by millions of consumers for various ailments, diseases and medical conditions. For most, prescription drugs can provide great benefit or relief. A consequence of the development of many drugs and the marketing to millions of consumers, are serious side effects or other undesired results. In extreme cases, the U.S. Food & Drug Administration (FDA) or manufacturer may recall or withdraw a drug.

Over the past few years, the safety of more than a dozen popular prescription drugs has been examined. In some cases, certain drugs have been recalled following reports of serious injury or death.

The recent recall of numerous popular drugs has resulted in heightened scrutiny of certain blockbuster drugs with hearings before Congress in which at least one FDA researcher suggests that the FDA may be incapable of protecting consumers from unsafe drugs and that several other popular drugs currently on the market may also present unacceptable patient risk. According to a survey by the Department of Health & Human Services Office of Inspector General, about two-thirds of Food & Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold.

DrugRecalls.com is a consumer resource from product liability lawyers engaged in assisting consumers suffering side effects from pharmaceutical drugs.

Not all drugs referenced on this website have been subject to recall or warning. Patients should never stop taking their medicine without first consulting with their physician.

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Drug Recall lawyer Dana Taschner is one of the most respected trial lawyers in the United States. Dana has represented numerous individuals in pharmaceutical cases throughout the United States and founded Drug Recalls to provide helpful news and legal information about significant drug recalls impacting millions of consumers. Dana has provided expert legal analysis on CNN and MSNBC, and has been involved in some of the most significant and challenging legal cases in the United States over the last three decades: See Wall Street Journal article quoting Dana on nationwide consumer lawsuits on July 8, 2011 http://online.wsj.com/article/SB10001424052702303365804576432051261804910.html.

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Dana has been involved in many of the most significant and serious Food and Drug Administration (FDA) or manufacturer drug recalls in history, including: Silicone Gel Breast Implants (FDA ban in 1992), Norplant (birth control implant recall), Fen-Phen (diet drugs recalled in September 1997), Rezulin (diabetes drug recalled in March 2000), Sulzer (hip device recalled in 2000), Baycol (cholesterol drug recalled in August 2001), Zyprexa (schizophrenia drug warning of 2004), Ortho Evra (birth control patch recalled in 2004) Avandia (diabetes drug recalled in July 2007), Paxil (SSRI Black Box Warning 2004), and Depuy Recall (hip device recalled in August 2010). Dana represented thousands of consumers adversely affected by these products after serious side effects or deaths were reported in connection to these pharmaceuticals. Dana has filed the first legal claim in the Courts of the United States following FDA or manufacturer recall in certain national recall cases.

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For twenty consecutive years Dana has been awarded the highest national AV-rating (preeminent) for his legal ability and ethics based on reviews by judges and lawyers. Dana was awarded the American Bar Association's Sole Practitioner of the Year from a field of 400,000 lawyers, and the United States Senate honored Dana with a Senate Tribute, stating, "Taschner has achieved national recognition… Taschner truly brings honor to his profession." The Senate Majority Leader read into the Congressional Record, "Mr. Taschner's devotion to fighting oppression earned him the American Bar Association's Lawyer of the Year award."