Defective Medical Device

FDA Focuses on New Studies to Determine Safety of Surgical Mesh Implants

Published on: February 13, 2012 | by The Borchardt Law Firm, PLLC

The FDA has continued to further pursue research and studies concerning the safety of all urogynecologic surgical mesh implants due to the increased number of complaints and litigations. Filed complaints continue to increase across the U.S. as the FDA looks more closely into research. Complaints began several years ago as women were experiencing severe side effects after having vaginal mesh surgically implanted to help treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Vaginal mesh has been on the market since 2002, having several pharmaceutical companies provide it. Within only two years, the FDA had received over 1,500 complaints filed by patients and doctors. Several women’s procedures resulted in multiple revision surgeries that still left them with unsatisfying results. In October 2008, the FDA issued the first Public Health Notification, warning patients about the possibility of the device failing and the potential side effects that they were not informed about. As complaints continued to pile up, in July 2011, the FDA issued their second safety warning to patients stating that, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare, and it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.” (read full article)

January 2012, the FDA met again to review new studies and undergo new measures of research. Based on Medical Device Reports, published literature and the 2011 Obstetrics-Gynecology Device Panel meeting, the FDA is debating whether or not urogynecologic surgical mesh used for transvaginal repair of POP be reclassified from Class II to Class III. They administration is going to continue to evaluate the safety and success of urogynecologic surgical mesh devices through new procedures and continue to inform the public of any safety warnings. (view full list of new procedures)

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Metal on Metal Replacement Systems Possibly Linked to Cancer

Published on: February 8, 2012 | by The Borchardt Law Firm, PLLC

A British study shows a possible link between several metal-on-metal replacement devices and an increased risk in cancer. The Sunday Telegraph, a British newspaper, disclosed results from a recent study that show the potential link. Over the past couple years, doctors and patients began second guessing the performance of metal-on-metal replacement systems. Several systems were failing within only a few year of surgery, causing multiple revision surgeries and still no improvement in pain.

In 2010, a leading manufacturer of an all metal-on-metal hip replacement system, DePuy Othaepedics, recalled more than 90,000 hip replacement systems due to an unusually high failure rate. Studies showed the metal-on-metal hip replacement systems were found to shed tiny pieces of metallic ions that led to a high risk of causing permanent tissue, muscle and bone damage. According to the Sunday Telegraph, “there are also concerns that metal traces in the blood could put major organs at risk of being slowly poisoned, and increase the chance of cancer – in particular in the kidneys and bladder.”

The article discusses results from a recent in-depth study that found genetic damage to the bladders of 17 out of the 72 patients tested, three of the 17 patients developed cancer. British regulators plan to continue further research and warn patients about continuous tests and to be aware of any signs or symptoms. (read full story)

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FDA Puts Johnson & Johnson Back In The Headlines

Published on: January 23, 2012 | by The Borchardt Law Firm, PLLC

A warning letter sent by the U.S. Food and Drug Administration (FDA) puts Johnson & Johnson back in the headlines. On December 8, 2011 the FDA disclosed new information in a warning letter stating one of the company’s subsidiaries sold multiple types of orthopaedic devices with out the required approval from regulators. The letter was based on an inspection of DePuy Orthaepedics from May 10, 2011 to June 7, 2011. The inspection showed DePuy had cleared 14 devices, mostly knee or hip systems, with out receiving proper approval from the FDA.

Unfortunately for Johnson & Johnson, this isn’t the first time for DePuy to make the headlines for negative publicity. In August of 2010 Johnson & Johnson issued a recall for their ASR XL Acetabular Hip Replacement System after receiving hundreds of lawsuits due to the failing device. Before the recall, the company believed the ASR XL Acetabular system was used in more than 90,000 patients, creating a large amount of concern for the majority of those patients.

Since the ASR XL Acetabular recall, Johnson & Johnson has been closely watched by the FDA. With the most recent warning, the company is striving to maintain a positive image. After the warning letter was sent out in December, DePuy responded by stating that the cleared devices were custom-made for certain patients and did not need the regular required approval. However, the FDA argued otherwise stating that, “the fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.” The FDA also stated that DePuy failed to obey with quality regulations for the devices. DePuy has currently discontinued all custom-made devices and is trying to answer all questions that raise concern in the warning letter.

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Johnson & Johnson Under Pressure, Depuy Hip Implant Still on Recall

Published on: November 7, 2011 | by The Borchardt Law Firm, PLLC

Johnson & Johnson still taking a hard hit after thousands of the Depuy artificial hips were recalled in 2010. The well known company has faced hundreds of medical device lawsuits due to the failure of the product.

August of 2010, the DePuy ASR XL Acetabular was recalled due to unusually high rates of hip implant failure within only a few years of surgery. DePuy estimated the failure rate to be about 12-13 percent and was designed to last up to 15 years. However, results showed otherwise. Several patients ended up in constant pain resulting in several revision surgeries only a few years after the implant. Doctors continue to warn patients about the risks of all metal-on-metal hip implants. Due to the full metal design of the Depuy hip, the implant is known to shed tiny pieces of metallic ions that lead to a high risk of causing permanent tissue, muscle and bone damage. Though all orthopedic implants shed debris after a few years, the metal-on-metal poses a higher threat that can cause severe lifelong problems.

As doctors and surgeons continue to recommend other procedures of hip implants to patients rather than the metal-on-metal implants, Johnson & Johnson is striving to boost the reputation of their company. According to The New York Times, “Johnson & Johnson pleaded guilty in April 2011 to bribing European doctors and agreed to pay $70 million in fines, as a wide-ranging government investigation of corrupt overseas marketing practices by drug and device makers scored its first major victory. At least a dozen other major drug and device makers are under investigation for similar crimes.” (read full article)

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Transvaginal Mesh Lawsuit Boost FDA’s Concerns, Possible Recall for the Medical Device

Published on: October 31, 2011 | by The Borchardt Law Firm, PLLC

While the Food and Drug Administration (FDA) determine whether to place a stronger emphasis on their safety warning about transvaginal mesh, a number of medical device litigations continue to spark concern. After receiving more than 1,500 complaints in just two years, the FDA is currently looking more closely into the serious side effects of transvaginal mesh, questioning whether the products should be pulled from the shelves.

In September 2011, a South Dakota woman filed a lawsuit against Johnson & Johnson over their vaginal mesh product, Gynecare Prolift. What was suppose to be a simple and easy procedure resulted into twelve failed surgeries and long term severe side effects. According to ABC News, after having her surgery in 2006, the patient has continuously suffered from “urinary complications, constant pain and swelling as her body continues to reject the mesh. She says she can’t sit for more than 20 minutes, she can’t have sex with her husband, and she can’t be active for more than a few minutes at a time. ‘It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain.” the woman told ABCNews.com. “I wouldn’t wish this on anyone.'”
At the time of the implantation, transvaginal mesh had not yet undergone the FDA’s standard testing for medical devices, instead the product was approved by the 510(k), a plan that “allows devices to go to market taking a short cut through the regulatory procedures as long as they are proved to be “substantially equivalent” to something already on the market”(ABC News). Johnson & Johnson had compared the Gynecare Prolift to one of their similar products, Gynemesh, which has been on the market since 2002. The patient is in the process of suing Johnson & Johnson for compensatory and punitive damages, she is also hoping to raise the awareness to women across the U.S. about the dangers of transvaginal mesh. (read full story)

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Transvaginal Mesh Lawsuits Continue to Increase as FDA Continues to Express Concern

Published on: October 17, 2011 | by The Borchardt Law Firm, PLLC

As transvaginal mesh lawsuits consistently increase across the Dallas/Fort Worth area, The Food and Drug Administration (FDA) continue to warn doctors and patients of serious complications involving the surgical placement of transvaginal mesh used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

In 2008 the FDA issued a Public Health Notification and Additional Patient Information to inform the public about the high risks of serious complications. According to the FDA, results have shown over 1,000 adverse events were reported to the FDA during a 3-year period, since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices. The most frequent complications reported for POP repair included protrusion, pain, infection, bleeding, dyspareunia, organ perforation and urinary problems. Many of these complications led to additional medical or surgical treatment and hospitalization.

Based on the results, the FDA’s concerns have significantly increased. “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported in 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.” (FDA)
(read full story)

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Medical Device Litigation Involving Metal-on-Metal Hip Replacement Sparks Concern

Published on: October 5, 2011 | by The Borchardt Law Firm, PLLC

As hip replacement lawsuits continue to rise, so do serious health concerns about metal-on-metal hip replacements. According to the New York Times, a top Boston surgeon went in to replace his 53-year-old patient’s hip and found devastating results. What researchers had warned patients of years ago has finally sunk in. The patient’s metal-on-metal hip replacement had been shedding tiny pieces of metallic debris that eventually led to what looked like a “biological dead zone. There were matted strands of tissue stained gray and black; and a large strip of muscle near the hip no longer contracted.” (New York Times) The damage was far worse than test results had shown and looked to be permanent.

Surgeons across the U.S. have found this problem to be significantly increasing with metal-on-metal hip replacements. The Boston surgeon, Dr. Young-Min Kwon stated that this could be one of the country’s biggest medical device failures yet. Though all orthopedic implants shed debris after a few years, the metal-on-metal poses a higher threat that can lead to permanent damage of the tissue, muscle and bone due to the metallic ions that are being shed. (read full article)

As studies continue to prove metal-on-metal hip replacements aren’t working properly, doctors and surgeons are trying new tests to find better results before the problem worsens. Patients are encouraged to be aggressive about consistently testing their results for metal levels and to speak to their doctors about recent recalls.

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Medical Malpractice Lawsuits On The Rise, Metal-on-Metal Hip Implants Prove To Have Unsuccessful Results

Published on: August 31, 2011 | by The Borchardt Law Firm, PLLC

Is DePuy Orthopaedics facing yet another possible recall due to a defective medical device? August of 2010, the DePuy ASR XL Acetabular was recalled due to unusually high rates of hip implant failure within only a few years of surgery. DePuy estimated the failure rate to be about 12-13 percent and was designed to last up to 15 years. However, results showed otherwise. Several patients ended up in constant pain resulting to a revision surgery.

Due to the design of the ASR, the metal material was a leading factor in the failure. Adverse Event Reports disclosed to the Food and Drug Administration (FDA) that the DePuy ASR hip system is associated with “loosening, pseudotumour and metallosis” / (sic) metalosis.” Metallosis occurs when the DePuy ASR metal ball rubs against the metal cup which releases metal shavings of cobalt and chromium into the tissue and circulatory system. This causes tissue necrosis and osteolysis, killing or severely damaging body cells and tissue.

Four months after the recall an article written in the New York Times discussing the issues with DePuy hip replacements stated, “failures in new implants are much more likely rather than failures with new drugs because unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients. That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the ASR, that process unfolded with devastating results. ‘You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic.'” That August DePuy issued a recall for more than 90,000 of the DePuy ASR metal hip implants. Read more about the recall in The New York Times.

Now, concerns have developed about all metal-on-metal hip implant procedures causing surgeons and doctors to rethink implants. DePuy Orthopaedics still offers one other type of metal-on-metal hip implant, the Pinnacle. The Pinnacle has a slightly different design, using a cup and a liner, whereas the ASR only uses the metal cup. Patients and surgeons are able to choose a metal-on-metal, metal-on-ceramic, or a metal-on-polyurethane line to be inserted inside the metal outer cup for the Pinnacle. However, studies have shown the metal-on-metal option for the Pinnacle has proven to cause very similar problems as the ASR model, mainly concerning the release of metal shavings of cobalt and chromium into the tissue and circulatory system.

In May 2011, nearly 60 DePuy hip lawsuits were incorporated in multidistrict litigation (MDL), all citing problems with the Pinnacle procedure. As of today, DePuy claims their Pinnacle device is safe, and any problems that have been accounted for are from surgeon error, though the Pinnacle is the subject of these recent lawsuits and were recently concentrated in the Northern District of Texas.