FDA to Convene Meetings in June to Review and Discuss Metal on Metal Hips

Fda (Photo credit: Wikipedia)

The Food and Drug Administration will hold a two-day meeting in June to discuss growing safety concerns about metal-on-metal hip replacements, which recent studies suggest are more likely to fail than traditional plastic hips.

Metal hip joints have been under scrutiny due to reports of pain and swelling that have sometimes required removal. In 2010, Johnson & Johnson recalled roughly 93,000 implants. The FDA already asked device companies to conduct additional follow-up studies to monitor problems with the implants.

The agency says it will hold a two-day meeting beginning June 27 to consider whether more rigorous testing standards are needed.

Earlier this month, British experts said doctors should stop using metal hip joints because data show they have to fixed or replaced more often than older implants.

J & J Mesh Product Based on Recalled Product.

Source: Bloomberg

Pelvic Mesh treats incontinence and a condition called pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the notion that if one device has been cleared by the FDA then similar devices need little if any testing in patients.

The chain of approvals that began with Boston Scientific’s device highlight a key flaw in the 510(k) process, said Amy Allina, a policy director at the National Women’s Health Network, a Washington-based advocacy group.  The system lets manufacturers win clearance for a product by citing its similarity to an already approved device, known in FDA jargon as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on.

“If a first iteration is recalled, they don’t necessarily look at the second, third or fourth things that are based on that,” Allina said in an interview. The system, she said, “is a mess.”

The story began in 1996, when Boston Scientific won clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J wasn’t required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.

A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, painful sex, and erosion of vaginal tissue. Nonetheless, J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.

The FDA has said it doesn’t know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010.

In the case of vaginal mesh implants, the FDA continued approving the hammock-like devices made by J&J and other companies based on their similarity to Boston Scientific Corp. (BSX)’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

The complaints are the latest to implicate the approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and numerous other products.

In the case of Johnson and Johnson, this is nothing new.  How may recalls have we seen from this company in the last 36 months.  Where was the FDA when other countries with databases were recalling J&J's faulty hips that now may have affected 34,000 Americans and subjected them to toxic levels of heavy metals.  I guess those guys just don't want to mess up those cushy jobs waiting for them when they leave government service to cash in.

In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious, if rare. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.

To learn more about Pelvic Mesh Implants, visit: http://www.pelvicmeshlawyer.com/about_mesh_implants.html

Congressional Hearings on DePuy Hip Devices

On April 13, 2011, the United States Senate Special Committee on Aging conducted a hearing that focused on the DePuy ASR hip replacement recall and the role the FDA played in allowing this untested and dangerous product on the market.

The first witness to speak was Katherine Korgaokar, who was implanted with a defective DePuy ASR hip device. After learning of DePuy’s recall, Ms. Korgaokar underwent blood tests that found that her metal ions were 1,000% higher than they should be. Because of the extremely negative health effects of high cobalt and chromium levels in her body, her doctor recommended that she undergo a painful revision surgery to remove the recalled hip device.

Ms. Korgaokar’s testimony about the difficulty in recovering from the revision surgery is familiar to the thousands of patients who are in her shoes:

“The recovery from this second operation has been substantially more difficult than my first. The pain is much worse and it has been extremely difficult to get around. Only recently has my mobility improved to the point where I no longer need crutches. For the past three months I have essentially been confined to my home trying to get through this.”

The Government Accountability Office also testified about its findings in a recent report that found that the FDA is lacking in its ability to adequately protect the public from dangerous medical devices such as the DePuy ASR hip replacement. Among other things, the GAO found that:

“shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities–from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.”

Since DePuy was forced to recall the defective ASR hip implants in August, an MDL was formed to handle those lawsuits. Attorneys who have filed lawsuits on behalf of clients who have been injured by DePuy’s Pinnacle Hip System have petitioned the U.S. Judicial Panel on Multidistrict Litigation that all of the federal DePuy Pinnacle lawsuits be consolidated and centralized before a single District Judge. If the panel agrees to form a DePuy Pinnacle MDL, a new MDL will be formed that will solely focus on DePuy Pinnacle lawsuits.

This MDL will function in a similar manner as the MDL for ASR’s. All discovery and pretrial motions will be consolidated under one District Judge and the lawsuits will revert back to their original districts for trial, if necessary. Injuries from the Pinnacle Hip System are similar to ASR injuries: pain, swelling, inflammation and metal poisoning. High levels of cobalt and chromium found in blood and urine samples are causing the most alarm as metallosis can cause rashes, soft-tissue damage and pseudo-tumors.

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.