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Transvaginal Mesh Safety Information and History

Transvaginal Mesh Safety Information and History

If you have suffered an injury caused by transvaginal mesh, you may be looking for transvaginal mesh safety information, or the history of FDA action and research regarding this device. The FDA and several research studies have issued safety warnings following thousands of reports of adverse events. In 2010, more than 10,000 women underwent vaginal mesh surgery to repair Pelvic Organ Prolapse. An estimated 15% of patients suffered a serious complication. If you were hurt by transvaginal mesh implant, you may have a transvaginal mesh lawsuit and be entitled to significant compensation.

What You Can Do & How a Transvaginal Mesh Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting Transvaginal Mesh complication cases in all 50 states. If you or somebody you know has been injured by this medical device, you should contact our lawyers immediately for a free Transvaginal Mesh lawsuit consultation. Please use the form below to contact our Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Transvaginal Mesh Safety Information

October 2008, the FDA issued a public health notification because they began receiving reports of serious complications associated with transvaginal mesh and surgical mesh. The products were being used for the treatment of pelvic organ prolapse and stress urinary incontinence, which are incontinence problems that are caused by a weakening of certain abdominal muscles. The mesh “slings” were being used to support the muscles and help a person regain control of their bladder.

Unfortunately, in 2008, the FDA received more than 1,000 reports that patients were experiencing serious complications.

Transvaginal Mesh Complications

The most serious and common transvaginal mesh complications reported to the FDA in 2008 included:

  • Erosion of mesh through the vagina
  • Infection
  • Pain
  • Bladder perforation during insertion of the mesh
  • Blood vessel perforation during insertion of the mesh
  • Vaginal scarring leading to significant decrease in patient quality of life
  • Pain during intercourse

Study Ended Prematurely: 15% of Mesh Patients Suffer Complications

In October 2010, researchers announced that they were forced to end a study prematurely after finding important transvaginal mesh safety information: More than 15% of transvaginal mesh patients suffered a serious complication. The researchers were studying 65 women with Pelvic Organ Prolapse. The women had randomly been assigned to undergo vaginal mesh or a traditional procedure, known as a colpopexy, in which a patient’s own ligaments are used to support the sagging muscles.

The researchers concluded that the vaginal mesh was no more effective than alternative treatments, but carried a significantly higher risk of side effects.

FDA Recommends Patients Use Alternative Treatments

In July 2011, the FDA issued a communication regarding transvaginal mesh safety information after it received an additional 2,874 adverse event reports from patients who had transvaginal mesh implants. This was on top of the 1,000 the FDA had received by 2008.

The FDA had continued to receive reports of transvaginal mesh complications, including: erosion into the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems, and mesh shrinkage.

The FDA recommended that physicians and patients consider alternatives for treating Pelvic Organ Prolapse and Stress Urinary Incontinence.

Transvaginal Mesh Should be Considered “Experimental”

In 2011 the Journal of Obstetrics and Gynecology Canada published a study of the safety and effectiveness of the transvaginal mesh procedure. The researchers concluded with a recommendation to patients and their physicians: “Until adequate effectiveness and safety evidence is available, the use of new transvaginal mesh devices for prolapse repair should be considered experimental and restricted to use in investigative trials.”

Transvaginal Mesh Recall

August 2011 The FDA announced the recall of transvaginal mesh devices. The products were made by Boston Scientific Corporation and included the following products:

  • Pinnacle Pelvic Floor Repair Kit – Anterior / Apical STERILE
  • Pinnacle Pelvic Floor Repair Kit — Posterior SERILE

The devices were recalled because they may exhibit low tensile strength between the needle and suture and lead to needle detachment during placement.

Following this announcement, an FDA advisory committee met and determined that they needed to recommend tougher pre-market testing of the devices to ensure that fewer defective products reached the U.S. marketplace and endangered the health of consumers.

Transvaginal Mesh May Become Class IIII “High-Risk” Medical Device

January 2012. Due to the large amount of troubling transvaginal mesh safety information, many were concerned about the high rate of complications and failures. This prompted the FDA to consider elevating the classification from a Class II to a Class III. A Class III device is considered “high-risk” and the manufacturers must abide by certain obligations. Obligations include conducting pre-market approval from the FDA before the products can be sold in the U.S. It would also obligate manufacturers to conduct continual safety studies to minor the safety and effectiveness of the product once it is on the market. The marketers would also be obligated to provide updated transvaginal mesh safety information to prospective patients.

FDA Asks Manufacturers to Conduct Additional Safety Studies

January 2012 In addition to considering whether to reclassify transvaginal mesh, the FDA will also be asking the manufacturers to conduct new safety studies of their products.

  • To 33 manufacturers of surgical mesh, the FDA has asked them to complete 88 post-market studies
  • To 7 manufacturers to single-incision mini-slings, the FDA has asked them to complete 11 post-market studies

Until this notification, transvaginal mesh products were exempt from the pre-market and post-market requirements under the FDA’s 510(k) system, which has come under scrutiny now that these products have been shown to have a significant rate of adverse events.

Under the 501(k) program, medical products that are similar to existing products do not need to conduct pre-market or post-market safety studies. The company that makes transvaginal mesh claimed that because the products were similar to surgical mesh products for the treatment of hernias, the vaginal mesh products did not need to be studied. This lack of studies prevented transvaginal mesh safety information from reaching the public and adequately warning them of the risks.

Do I have a Transvaginal Mesh Lawsuit?

The Schmidt Firm, PLLC is currently accepting Transvaginal Mesh induced injury cases in all 50 states. If you or somebody you know has experienced a serious complication caused by Transvaginal Mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Transvaginal Mesh Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.

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