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Coloplast Transvaginal Meshes in Spotlight at FDA Panel

  • February 19, 2019
  • KBA Attorneys
  • No Comments

A woman’s pelvic health is very important, but many injuries can easily pop up over time. In this day and age, women have many possible remedies.

One such remedy is what is known as transvaginal mesh. Surgical mesh is designed to help with pelvic organ prolapse. In general, such methods are used after a woman has suffered from injury to this region as a result of childbirth or aging. While these products have advantages, they can also create problems that can threaten a woman’s overall health. Serious injury and even death can result when the mesh fails to work or causes more issues.

FDA officials have looked closely at the issues of transvaginal meshes and found the use waning in the last few years. They have found over ten thousand reports of issues with these products, over eight hundred reports of malfunctions with the products, and found dozens of reports of deaths as a result of injuries in part because the product failed. There’s the possibility of mesh erosion, on average between eleven and eighteen percent overall. The reality is that the failure of the product is a problem with about one in ten procedures, and should concern all women and their doctors.

Many adverse effects have been noted, including ongoing pain in the pelvic region. FDA officials have also found that women may suffer from other effects. A woman may experience scarring that can make it hard for her to conceive. Bleeding and infection can also be an issue with the use of such meshes over time. Women with such developments as a result of these issues may also experience problems with depression. Under these circumstances, officials at the FDA are calling for a closer look at these implants over a longer period of time beyond a year in order to see what kind of long term issues may arise that might have otherwise been overlooked by other safety studies.

While the FDA argues that longer studies may be needed, some groups are not entirely convinced of such issues. Several manufacturers have argued that further studies are not needed. They argue that surgeons are in need of options to help fix such problems, and that the meshes provide them with the help that many women need in order to prevent ongoing problems with pelvic prolapse that can make it harder for women to function in their daily lives.

The group further argues that surgeons know how to select the proper candidates for the procedure and make sure the meshes are a good fit for their overall lifestyle. Officials at the American Urogyencologic Society have also argued that such devices should be kept on the market and used for selected patients. They believe there is no need for further studies as the product used can be helpful and make user’s lives better. Examination of transvaginal meshes is likely to continue in the future both for the FDA and medical manufacturing companies.

If you or a loved one have been the victim of injury through the use of transvaginal mesh, contact KBA Attorneys to help with developing your case. Our legal team has years of understanding of medical device lawsuits. Fill out our online application or contact us today for a case evaluation.