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Consumer Group Calls for Recall of Surgical Mesh

Consumer safety group Public Citizen has petitioned the Food and Drug Administration to recall vaginal mesh surgical products like the Bard Avaulta, because of the high risks that these pose to patients and the potential for long-term life altering injuries. According to the petition, the use of the surgical mesh products is very often physically and psychologically devastating for women, who may not even be aware that they have other choices besides the mesh.
 
Surgical mesh products like Bard Avaulta are typically used to treat pelvic organ prolapse in women. Pelvic organ prolapse is a condition that develops after childbirth. Organs like the bladder and the uterus shift out of position, and protrude through the body. A surgical mesh product like the Bard Avaulta is implanted to keep the organs in place.

Apart from Bard Avaulta, which is manufactured by C.R. Bard Inc., surgical mesh products are also manufactured by Cook Medical, Ethicon, which is a division of Johnson & Johnson and Covidien PLC.

In October 2008, the Food and Drug Administration warned about specific dangers from the use of the surgical mesh products. The agency has received more than 1,000 complaints of adverse events, and companies like C.R. Bard Inc. have been slapped with product liability lawsuits.
 
Some of the injuries that women have reported include chronic and acute pain, incontinence, and recurrence of the prolapse. Women have also suffered from infections, inflammation, and formation of abscesses. Many of the women have reported pain during sexual intercourse. The use of surgical mesh has also been linked to the shrinkage of tissues. In some patients, the injuries have been so severe that patients have required blood transfusions and even additional surgeries.

Los Angeles Bard Avaulta lawyers find the worst part about these injuries is that they're so preventable. Experts have since found that many cases of pelvic organ prolapse can be treated without implantation of surgical mesh devices. However in 2003, a study found that every year approximately 200,000 surgeries to implant mesh products are performed in the United States.

NYT Analysis Indicates Increase in Hip Implant Complaints

An analysis of a federal hip implant complaint database by the New York Times indicates that there has been a surge in the number of complaints related to hip implant devices like DePuy’s ASR devices and Zimmer’s Durom cup.
 
The analysis also shows an increase in the number of metal-on-metal hip implant complaints. According to the New York Times analysis, the agency has received about 5,000 complaints related to metal-on-metal implants manufactured by DePuy since January this year alone. The analysis found a total of 7,500 complaints regarding these devices. The analysis also found about 1,500 complaints regarding the Durom cup between 2007 and June 2011.

However, it is difficult to say exactly how many complaints involve all-metal implants, because complaint reports were not filed a standardized manner.
The New York Times analysis comes even as hip implant manufacturers like DePuy, Zimmer and Wright Medical lay the groundwork for studies on the safety of these devices. The Food and Drug Administration ordered these companies to study the safety of hip implants, after a wave of complaints and recalls of defective hip implants. The companies have recently been in touch with health providers like Kaiser Permanente and hospitals that have their own patient registries, to recruit patients for the studies. These companies have already presented their proposed plans for the studies to the Food and Drug Administration, which will decide on the effectiveness of these proposed studies by November.
 
California hip implant recall lawyers would like the studies to recommend systems to measure the amount of metallic ions from these devices that are leaked into the bloodstream, and ways to measure the extent of bone loss from the use of these implants.

The Food and Drug Administration is right to worry about all-metal hip implant devices. The agency believes that these devices are the biggest medical implant-related issue the Food and Drug Administration and California product liability lawyers have faced since Medtronic's cardiac implant device problems a few years ago.

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