(LegalLaw247.com, February 08, 2012 ) Philadelphia, PA -- According to a recent Bloomberg news story, House Democrats are calling for congressional hearings on vaginal mesh products made by Johnson & Johnson. Legislators want to hold these hearings because they say that the device has harmed many patients.
Rep. Henry Waxman, (D-Cali.) and three other colleagues urged Republicans who control the House Energy and Commerce Committee to hold hearings and demand documents from the device manufacturers. This inquiry comes to light when Congress is considering an overhaul of the Food and Drug Administration's (FDA) rules on medical devices, Democratic law makers said in a statement.
Last month, the FDA ordered Johnson & Johnson, C.R. Bard, and 31 other manufacturers to conduct clinical trials on safety and effectiveness for three years. In July 2011 the agency released a formal warning against the device, but said it did not have enough data to support a recall.
The agency first became concerned about the device in 2008 when it urged health care professionals to warn their patients of any complications that they deemed as rare, but serious. Complications of the device include, but are not limited to: bleeding, infection, and painful urination. According to a report issued by the FDA in July 2011, the most commonly and consistently reported complication is what is called mesh erosion where the device erodes into surrounding tissue. To learn what other complications are associated with this device, please visit LegalView's vaginal mesh portal: http://vaginalmesh.legalview.com/.
Since its report last year, more than 650 law suits have been filed by women who claim they have been hurt by the device. Many women who allege this have had to undergo several corrective surgeries, and since the device is designed to grow around human tissue, it is extremely difficult to remove.
Another issue at hand that is of concern to many is the FDA's medical device approval process in which medical devices can get market approval without human testing as long as manufacturers can show that their device is significantly similar to those already on the market. This approval process is called the 501(k) process. When vaginal mesh was initially introduced, the FDA approved it using a very strict approval process, but any other vaginal mesh products were approved under its 501(k) process, even after the original device was shown to cause problems or was removed from the market.
If you or a loved one is suffering the adverse effects of a trans vaginal mesh implant, please visit http://www.legalview.com to speak to one of our medical device attorneys.
About LegalView:
LegalView is a public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of the nation's most highly respected law firms: Anapol Schwartz; Cohen, Placitella and Roth; James F. Humphreys and Associates; and Lopez McHugh. For more information on the accomplishments and track records of LegalView's superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at http://www.Legalview.com.
LegalView
Danielle Franklin
9702168847
press-releases@legalview.com
Source: EmailWire.Com
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