The vaginal mesh issue continues to be very controversial even among specialists in the field of gynecology and urology. Since its introduction in the early part of the decade, the use of vaginal mesh for the treatment of urinary incontinence and pelvic organ prolapse has become a very routine procedure in hospitals across the United States. The very high failure rates resulting from vaginal mesh implants being manufactured have triggered heated exchanges between pelvic floor specialists, gynecologists, and urologists.
If suggestions from certain quarters will be given credence, this issue touches on the area of ethical responsibility. It was reported by the US Department of Health that around three-fourths of adult women will be affected by pelvic-related conditions and that one in 10 of these patients will need surgical intervention. One does not have to be a genius to determine the amount of business this certain medical device will generate using these figures.
Adding fuel to this debate are the accusations within the American College of Obstetrics and Gynecologists in the removal of the word “experimental” in describing these devices. It has been alleged by members of the group that this was done for commercial considerations.
Depuy Orthopeadics, a business unit of Johnson & Johnson, is currently facing a huge dilemma nowadays since it made a voluntary recall of its ASR hip system in 2010. The company spent $800 million alone for the recall, with the hope the problem stops there.
Unfortunately, the recall of its 93,000 hips worldwide was merely the beginning of the many issues that the company will be facing, especially the 10,000 lawsuits filed for compensatory damages claims.
There are even cases that have already gone on trial because some of them were not satisfied with the $200,000 offer the company made per case.
According to Eric Gordon, a business professor at the University of Michigan, the company is expected to pay $200,000 to $500,000 per DePuy ASR lawsuit it seeks to settle amicably with certain complainants.
The United States Food and Drug Administration has proposed a more stringent regulation over all-metal hip replacement devices, according to online media reports. All-metal implants, which have been the subject of several studies and product recalls, including the 2010 DePuy metal-on-metal hip implant recall, may now go through a longer review process and may not be offered to patients unless other alternatives or safer options have been taken into careful account. The tightening of regulations comes amid to nearly 500,000 reports of hip implants which have failed prematurely in recipients.
Currently, hip replacement implants are being regulated through a less strenuous process designed for low-risk medical devices, according to the US FDA. Under the newly proposed order by the agency, manufacturers of metal-on-metal implants, classified as high-risk devices (Class III), would have to submit premarket approval (PMA) applications and prove the safety and effectiveness of their products before they could continue marketing new or existing designs.
The DePuy Orthopeadic, a business unit of Johnson & Johnson, received several complaints over their two ASR Hip Systems which its officials into calling for a voluntary recall in 2010, medical experts say. Since product pull-back order, the company was able to gather 93,000 devices worldwide, including the 37,000 in the U.S., saying more than 12 percent of the devices failed within five years. There are about 8,000 recipients who have filed lawsuits seeking compensatory damages. In fact, opening arguments would be starting soon in the first DePuy state court trial.
One of the major issues with the DePuy ASR implants is the grinding of its hip’s ball-and-socket structure which causes metal debris to collect in the tissue surrounding the implant, damaging muscle and tendons and complicating replacement surgery. In some cases, metal ions released into the blood sparks broader health problems.
Around $800 million have been spent on the recall in the past two years. However, it won’t able to disclose details on its product-liability costs, citing policy constraints.
According to Eric Gordon, a business professor at the University of Michigan who is following the pharmaceutical industry that it may cost the drug maker as much as $2 billion to resolve all DePuy hip recall lawsuits.