FDA Keeps Track of Robotic-assisted Surgery Complications

Robotic-assisted surgery continues to rise, medical industry observers pointed out, as most hospitals in the United States and other countries are now offering it as part of their services. Although along with the rise in the number of robotic-assisted surgeries performed in different hospitals, the number of adverse event reports to the US Food and Drug Administration has also risen, according to the article published in the Medscape Today News. This unsettling development in the use of the Da Vinci surgical system resulted to an inquisition of surgeons who have used the robotic assistant from the FDA, according to the said article.

Several critics of the said medical device indicated that the massive marketing of the surgical robot may have influenced the increase in the numbers. Debates regarding the safety of these robotic assistants inside the operating rooms are still being discussed by health care providers and critics alike. The FDA’s Manufacturer and User Facility Experience (MAUDE) are responsible for collating all the medical device reports that are being submitted to the FDA. Medical device manufacturers, imports and device user facilities (i.e. clinics and hospitals) are mandated by law to submit reports regarding any injury or complications that may have been caused by their device that may have resulted to serious injuries or death of the patient. Voluntary reports may be gathered from health care providers, patients and other consumers.

Malfunctions that resulted to the unintended cauterization of nearby tissues were being reported across different areas in the United States. Intuitive Surgical – the manufacturer of the Da Vinci surgical system, gave recommendations on how to avoid this kind of malfunction. In some cases the burn may not harm the patient but it may be different for others. The MAUDE database indicated an increase in the number of adverse reports related to the Da Vinci surgical system of 34 percent from 2011 to 2012 alone, according to the online report from the Medscape Today News. Whether the robotic surgical system is safe for the public or not may only be known as results from surveys and researches come in. Know more about the issues regarding these surgical assistants at www.davincilawsuit.net.

Second FDA Warning Issued Over Merck’s Drug Januvia

Many people are wondering why Merck has not added warning labels for Januvia despite the series of research studies conducted by medical researchers confirming an increase in risks of pancreatitis among its users, an online report says. The Food and Drug Administration (FDA) in March 2013 issued a new Januvia warning after the Journal for the American Medical Association published a study which showed Januvia side effects that could double the risk for pancreatitis that may lead to pancreatic cancer and kidney failure according to www.drugrisk.com. Januvia is an anti-diabetic drug manufactured by Merck since 2006 and has been very popular for treating adult patients with type-2 diabetes.

Since the drug was approved and has been sold in over 80 countries, several cases have been reported of patients suffering pancreatitis while undergoing Januvia medication. This led to the first official warning issued by FDA on 2009. In addition to that official warning there are two more research studies that were conducted on 2011 and 2013 by researchers from the University of California-Los Angeles and JAMA respectively, both showing negative results.

FDA has not been negligent in providing warnings although Januvia has not been barred in the market. Merck should have done its part by providing warning labels in their products especially Januvia. To read more about it, click here .

Source:

drugrisk.com

fda.gov

Ethical Implications Taint Vaginal Mesh Controversy

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.

Reference:
commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh

Is DePuy Settlement Enough to Cover Expenses?

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.

URL REFERENCES:
topics.nytimes.com/top/news/business/companies/johnson_and_johnson/index.html
bloomberg.com/news/2012-08-21/j-j-said-to-pay-600-000-to-settle-first-suits-over-depuy-hips.html

FDA Wants A More Stringent Regulation Over All-Metal Hip Implants

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.

Sources:
fwbusiness.com/business/latest/businessweekly/article_bb429ebc-6184-11e2-9c10-001a4bcf6878.html

nytimes.com/2013/01/17/business/fda-to-tighten-regulation-of-all-metal-hip-implants.html?_r=0

fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/
metalonmetalhipimplants/ucm241769.htm

How Much DePuy Spent For the Hip Recall?

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.

 

DePuy Hip Recall Video


DePuy Hip Recall

 

URL REFERENCE:
bloomberg.com/news/2012-08-21/j-j-said-to-pay-600-000-to-settle-first-suits-over-depuy-hips.html

First Surgical Mesh Trial Against J&J to Start in New Jersey

The initial trial on a series of surgical mesh cases filed against Johnson & Johnson has been arranged to start in a New Jersey state court in January 10, according to online news reports. The selection of potential jurors for the trial commenced January 7, and was on the course to finish with full jury panel on January 9.

The lawsuit, one of 1,800 cases pending against the company, was reportedly filed by Linda Gross, a 47-year old plaintiff from South Dakota. Gross allegedly suffered serious injuries following the implantation of the company’s Gynecare Prolift vaginal mesh product as treatment to pelvic organ prolapse (POP), purportedly causing her ongoing pain and to undergo 18 subsequent corrective surgeries. The lawsuit also argues whether or not J&J’s subsidiary unit, Ethicon, had provided sufficient warning of the potential risks associated with the indicated device.

Vaginal or pelvic mesh implants have been recently surrounded with controversies that describe their safety and effectiveness in different lights. Legal experts are also closely following the progress of bellwether trials of consolidated bladder mesh cases as these may help the possible realization of potential compensation.

Bladder Mesh Lawsuit Video


Bladder Mesh Lawsuit

Source:
bloomberg.com/news/2013-01-07/j-j-faces-first-vaginal-mesh-implant-trial-in-new-jersey.html