Home » Law and Legal Articles » Vaginal Mesh Products Prove Faulty
Vaginal Mesh Products Prove Faulty
In 1996, Boston Scientific gained approval from the FDA for a vaginally implanted mesh device used to treat incontinence. In July, the FDA issued a warning concerning these products, stating that serious complications were not uncommon and that using mesh may expose patients to greater risk while providing little or no benefit.
November 19, 2011 /Law and Legal PR News/ -- In 1996, Boston Scientific gained approval from the FDA for a vaginally implanted mesh device used to treat incontinence. Later vaginal mesh devices have been used to treat incontinence, as well as pelvic organ prolapse, in which internal organs like the bladder and uterus slump into the vagina. The mesh is meant to act as a barrier between the internal organs, keeping everything in its proper place.
FDA Approval and New Vaginal Mesh Devices
As with most medical devices, competitors soon sought to release their own mesh products. Due to an FDA policy, later devices were able to avoid the human testing component of the approval process by showing that their devices are similar to that original device. Later, when Boston Scientific pulled their original mesh product from the market because of reports of pain and questions over its effectiveness, these new entrants were allowed to continue releasing their devices based on similarity to the original mesh product.
As use of the devices has expanded, complaints and complications have led to greater scrutiny by patients and the medical community at large. In July, the FDA issued a warning concerning these products, stating that serious complications were not uncommon and that using mesh may expose patients to greater risk while providing little or no benefit.
A Problem With a Life of Its Own
A medical device gets to shortcut the approval process because it is similar to an already approved device. Then another device is approved based on similarity to the new device. This happens over and over again as long as manufacturers see a profit in releasing a new iteration. When the original product proves to be dangerous and defective and is pulled from the shelves, the new devices that were approved without a full investigation based on their similarity to the original device are not recalled.
While manufacturers like Johnson & Johnson still advocate the use and safety of their vaginal mesh products, patients are reporting serious problems. Many who have had the device implanted report intense, long-lasting pain, as well as issues like painful sex and erosion of vaginal tissue. Hundreds of defective product lawsuits have been filed against manufacturers of transvaginal mesh products.
A Potential Solution
As a direct result of the major concerns and complications presented by these products, there is a movement to reclassify transvaginal mesh devices as high-risk. A high-risk classification would require additional studies in order for the product to stay on the market. At this time, current models of these devices remain available for use by surgeons, but the FDA appears to be moving in a direction that will require additional research for future use. For the hundreds of thousands of women who have already had these devices implanted in them, the only solution may be to contact an attorney and pursue litigation against the manufacturers who profited from these dangerous devices.
Article provided by Seaman Garson LLC
Visit us at www.garson.com
---
Press release service and press release distribution provided by http://www.24-7pressrelease.com |
|
|
Press Release Contact Information:
FL Web Advantage
|
|
|
|
|
| LAW AND LEGAL ARCHIVE SEARCH |
|
|
| |
| SUBMIT LAW AND LEGAL NEWS |
|
|
| |
|
|
Advertise With Us |
About Us |
Contact Us