The Food and Drug Administration (FDA) has sent out a letter to Johnson & Johnson, C.R. Bard, and 31 other manufacturers of transvaginal mesh products saying that they must study rates of organ damage and other complications linked to these mesh implants. According to a Bloomberg News report, the FDA is asking mesh implant manufacturers to conduct three years of trials on the safety and effectiveness of these mesh products, after finding a five-fold increase in deaths, injuries, or malfunctions linked to these implants.

Serious Side Effects

According to the FDA, in 2010 alone, nearly 300,000 of these synthetic meshes were implanted in American women to treat incontinence or a condition called pelvic organ prolapse where the organs of the pelvis bulge, causing discomfort. However, these hammock-like devices, which are supposed to shore up pelvic muscles, have resulted in serious adverse effects in the women who have had them, spurring more than 650 lawsuits against the manufacturers.

In some women, the mesh cut into the vaginal lining causing infections and even nerve damage. Others could not sit down or urinate without a catheter. Some patients even had to be hospitalized or stop sexual intercourse because the symptoms had become so painful and unbearable. In July 2011, the FDA issued a safety alert warning consumers about the possible risks these defective products pose.

FDA’s 510(k) Program

These products are in the market in the first place because they received FDA’s stamp of approval through an agency program that does not require human testing. The meshes were approved through the FDA’s 510 (k) system, which allows the products to be sold in the market without human testing if the agency decides that they are similar to devices already for sale. The FDA is now asking these product manufacturers to collect data on the results of transvaginal procedures, and potential complications that can arise from the use of the product. Safety advocates say that the letters sent out by the FDA to mesh implant makers may be a first baby step toward requiring studies and human testing before medical devices are put on the market.

Mesh Makers Should Tell Consumers the Truth

There is no question that these products should not have been made available in the first place. Product manufacturers have an obligation to the user to only market products that have been tested for safety and effectiveness. With this particular product, nothing can change what has already happened to tens of thousands of women who have suffered through these terrible after effects. These are obviously high-risk devices. Women who wish to undergo these procedures must be informed about what they are getting into – the risks they face. It is time that the manufacturers of these mesh implants stop marketing them and start studying them, and more importantly, start telling the truth about these products.

Seeking Compensation

If you or a loved one has suffered complications as a result of vaginal mesh implants, please contact a reputed California personal injury lawyer who has experience handling similar cases. You can seek compensation for medical expenses, lost wages, hospitalization, pain and suffering, and emotional distress.