Pennsylvania Injury Lawyer Blog

There are many potential side effects of transvaginal mesh surgery. While painful sexual intercourse is not life threatening, it can certainly affect a person’s quality of life and is thus an important side effect to be aware of if you are considering transvaginal mesh surgery or if you have already had vaginal mesh surgery.

Vaginal meshes may cause painful sexual intercourse for a woman and her partner. Many patients, and their partners, want to know why. How does transvaginal mesh cause painful intercourse and is it fixable? Transvaginal mesh may cause painful intercourse when the mesh erodes through the skin, or is exposed in the vaginal wall. Often, the problem of painful sex will need to be resolved through further surgery to fix the eroded mesh.

Painful sex after transvaginal mesh surgery is an important symptom to report to your doctor as it may be a sign that the mesh has eroded through the vaginal wall. While it may not be the most comfortable topic to discuss with your physician, it

On January 4, 2012 the FDA issued an order requiring the manufacturers of transvaginal mesh to study its risks. Manufacturers such as Johnson & Johnson, CR Bard, and Boston Scientific will conduct studies on dangers of transvaginal mesh and report back to the FDA. The information gained from the studies will help the FDA decide whether transvaginal mesh devices should be reclassified as high risk.

While this recent action is short of an FDA recall on vaginal mesh, it is a sign that the FDA is concerned about vaginal mesh complications. If the FDA decides to reclassify transvaginal mesh, the process could take years. In the meantime, women considering transvaginal mesh surgery and women who have had transvaginal mesh surgeries should consult with their doctors about the warning signs of potential complications and how to treat them.

Your doctor will or has already implanted transvaginal mesh into your pelvic vaginal area. It is a medical device and has the same FDA classification as a condom.

Based on an increase of adverse event reports submitted to the FDA, evaluation of published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

The FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.

Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.

Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices -- the same as implantable transvaginal mesh.

Continue reading "Transvaginal mesh and condoms – FDA Class II" »

Currently, Johnson & Johnson is facing hundreds of lawsuits by women who allege they have been seriously injured by vaginal mesh implants made by the corporation. The company, one of the world’s largest health manufacturers of health products, was able to keep the mesh products on the market regardless of potential safety issues due to a highly criticized part of the U.S. Food and Drug Administration’s (FDA) approval process. The process glitch exists in a loophole that stipulates that if a product, or prototype, has been previously approved by the FDA then other comparable products require a lesser degree of safety testing, as reported by Bloomberg News.

However, amidst a plethora of headlines regarding defective and dangerous medical recalls and lawsuits, physicians, government officials, and the general public are pressuring the FDA for alterations on the antiquated system. In the instance of vaginal mesh, the agency kept passing the implants manufactured and sold by Johnson & Johnson with little to no testing, based on the product’s comparability to the ProteGen formerly made by Boston Scientific Corp which was removed from the market for safety issues. In lawsuits, affected women report continual pain and bodily harm from the products and in some cases multitudes of medical operations in attempt to correct resulting damages.

The Transvaginal Mesh products are used by women to treat pelvic organ prolapse as well as incontinence. While the FDA claims it cannot accurately estimate the amount of women with the implants since their first availability in 1998, it claims approximately 300,000 were utilized in 2010 alone. Last month, a panel of physicians (mostly pelvic surgeons) advised the FDA that the products should be re-listed as high risk and tested more in order to remain on the market.

Even though the FDA seems to be moving toward that decision, according to Bloomberg, its director said it could take as many as three years to implement the new standards, and until then, the products in question will remain available to the public. If you or a loved one has been injured by vaginal mesh implants in Pennsylvania, contact the transvaginal surgical mesh attorneys in Pennsylvania with Anapol Schwartz at (866) 735-2792.