Recently in Medical Device Law Category

November 30, 2011

Joint Commission Makes Recommendations On Use Of Transvaginal Mesh

A recent report issued jointly by the American College of Obstetricians and the American Urogynecologic Society details vaginal mesh recommendations, including that the mesh should only be used for certain high-risk women. The safety and efficacy of the synthetic mesh, also known as transvaginal mesh or bladder mesh, has been called in question, making its use only beneficial for a small percentage of women where the benefits outweigh the risks.

Vaginal mesh has been used for the treatment of pelvic organ prolapse, condition where the pelvic muscles become torn or stretching, causing the pelvic organs to "drop down and bulge" into the vagina. More the 350,000 women have surgery to correct this problem each year. In the past, vaginal mesh has been used to repair POP. However studies have shown that the mesh has cause serious complications such as pain, infection, and protrusion through the vagina, often necessitating additional surgeries. In fact, according to one report "a small but significant group experience permanent and life-altering problems, including pelvic pain and painful sexual intercourse because the mesh erodes through the vagina wall."

If you or a loved one has had surgery implanting the vaginal mesh and experienced complications, it is important to consult with an experienced transvaginal mesh attorney. Those injured as the result of this dangerous medical device may be entitled to compensation for their harm. A knowledgeable transvaginal mesh lawyer can advise you concerning your rights and provide critical guidance about your next steps.

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October 30, 2011

Transvaginal Mesh Device Based On Recalled Product

As women across the country continue to suffer complications from the use of Johnson & Johnson's transvaginal mesh devices, a new report reveals that the design of the bladder mesh was based on recalled transvaginal mesh devices that had been taken off the market more than ten years ago due to safety problems. The devices were designed to treat a condition called pelvic organ prolapse.

Transvaginal mesh, also referred to as a pelvic sling or bladder mesh - has been subject to increased scrutiny as the result of problems from its use including:

• Infection
• Vaginal pain
• Injury to nearby organs
• Bladder perforations
• Vaginal mesh hardening

If you or someone you love has experienced complications from the use of transvaginal mesh, it is important to speak with an experienced defective medical device attorney who can provide critical advice concerning your injuries. In many circumstances, you may be entitled to monetary compensation.

Here, reports indicate that even though the FDA had pulled a similar mesh design created by Boston Scientific Corporation from the market, the FDA continued approving the similarly designed vaginal mesh created by Johnson & Johnson. Now, makers of the implant face more than 600 lawsuits nation wide from women who have suffered serious injuries from the devices. The devices were approved as part of FDA's 510(k) process that allows "fast-track" approval of medical devices where a similar device is already on the market. The fast-track process allows new devices to be approved with little - if any - testing on patients.

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October 12, 2011

Transvaginal Mesh Linked To Serious Side Effects And Complications

The FDA has recently issued an updated transvaginal mesh warning on the use of the mesh to help repair pelvic organ prolapse (POP). POP occurs when the pelvic organs fall out of place as the result of the stretching or weakening of the tissues holding the organs in place. Transvaginal mesh - also known as vaginal mesh, bladder mesh or a pelvic sling - has been used to surgical correct this condition. However, research has concluded that serious side effects and complications may result due to its use.

These side effects and risks include:

• Bladder perforation
• Pelvic hemorrhage
• Mesh erosion
• Infection
• Pain during intercourse
• Bleeding
• Incontinence

Although some of these effects may be reverse through additional surgeries, others may be life-long, debilitating consequences. According to the FDA - most cases of POP can be treated successfully without the use of transvaginal mesh. The implanting of this dangerous medical device unnecessarily exposes patients to the risk of harm.

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September 12, 2011

FDA Holds Hearings On Transvaginal Mesh

The FDA met last week to determine whether surgical mesh inserted surgically inserted into the vagina, also known as transvaginal mesh or pelvic mesh, needs tighter regulation by the FDA. The mesh is used to treat a painful condition called pelvic-organ prolapse. As the result of close to 3000 reports of adverse events, including seven deaths, the manufacturer - Johnson & Johnson now faces several lawsuits across the country.

Transvaginal mesh - like many other defective medical products - was allowed on the market as the result of an expedited regulatory process. The pelvic mesh is currently considered a Class II medical device and was allowed a quick entry into the market without preclinical testing if manufacturers were able to show that the devices is "substantially equivalent" to an existing device on the market.

The FDA is evaluating whether to change the classification of the transvaginal mesh to Class III - high risk. If the FDA changes the rating, the pelvic mesh would require additional testing and be subject to a longer approval period.

Based on initial reports of the transvaginal mesh hearings, it appears that the advisory committee is in favor of stricter testing requirements. A number of risks are associated with the mesh, including organ perforation and bleeding, long-term mesh exposure to the bladder, vagina and rectum, pain and infection, urinary problems, as well as the need for additional revision surgeries. Several reports also indicated that the use of the mesh exposes patients to "unnecessary risk without a benefit above safer options."

As New Mexico transvaginal mesh lawyers, we support tougher regulations. Too often innocent patients are injured due to defective medical devices that are rushed to market.

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September 2, 2011

FDA Warns Of Risks Associated With Transvaginal Mesh

Recently the FDA issued a transvaginal mesh warning concerning the use of the medical device (also known as pelvic mesh, pelvic sling or bladder mesh) as a method to repair pelvic organ prolapse. The FDA warning stated that using transvaginal mesh to repair pelvic organ prolapse exposes patients to an "unnecessary risk" without providing any benefit above safer measures. Next week, the FDA will conduct hearings to determine whether stricter safety measures or a possible recall of the transvaginal mesh is necessary.

Problems from the medical device include pain, bleeding, infection, injury to nearby organ, and protrusion of the mesh through the vagina.

If you have undergone surgery for pelvic organ prolapse and surgeons used the pelvic mesh, it is important to consult with a transvaginal mesh attorney regarding your next steps.

According to an FDA representative, "There are clear risks associated with the transvaginal placement of mesh...The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh." This warning came after the FDA received reports of 1503 adverse events from 2008 to 2010.

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August 13, 2011

DePuy Hip Linked To Metal Poisoning

More and more claims concerning the troubled DePuy Hip continue to emerge. A recent article reveals that in additional to extreme pain from the faulty medical device, other symptoms related to metal poisoning occurred. According to one DePuy Hip patient - Tony Stauffer - discussed in the San Diego news, his hair started to fall out, he got skin rashes and his fingernails became brittle. These symptoms were linked to metal flakes coming loose from the joint with movement that caused metal poisoning. The metal poisoning then inflamed his hip joint and damaged his muscles.

If you have undergone hip replacement surgery and have a DePuy Hip, it is important to contact a New Mexico DePuy hip attorney to determine your next steps.

Stauffer is one of more than 94,000 DePuy Hip patients around the world who have received the implant. Lawsuits resulting from the defective medical device have been filed in New Mexico and around the country. Many blame the DePuy Hip problems both on the manufacturer and the FDA fast-tracking process that allows device manufacturers to rush products to the market without first ensuring their safety.

In fact, the FDA released a statement indicating its need for post market studies after receiving reports from patients that they "have developed symptoms or illnesses elsewhere in the body including the heart, nervous system and thyroid gland that may be due to the patient's reaction to metal ions released from the implant."

In fact, many patients have shown increased cobalt and chromium levels. Despite the recall that occurred in August 2010, the number of patients reporting injuries, pain and discomfort continue to rise. Doctors recommend immediate DePuy Hip revision surgeries in order to correct the problem.

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July 27, 2011

DePuy Hip Recall Makes Some Experts Question FDA Medical Device Review Process

A recently released medical device study concludes that the FDA should "abandon" its present system for approving U.S. medical devices such as the DePuy Hip because it fails to ensure patient safety.

Currently the FDA employs a streamlined approach to approve medical device applications such as those for the beleaguered DePuy knee and hip parts - a process that takes 10 months as opposed to several years.

However, this quick process is unreliable. As the result of a faulty or inadequate screening process, many patients with medical devices have found themselves harmed by medical devices, implanted with recalled items that require additional, painful and sometimes dangerous surgeries.

One patient who required revision surgery to fix a recalled DePuy Hip part states, "You put your faith in the doctor and the companies that make these products because they're the experts...It's just beyond me to think that things can get approved that don't really work" reports ABC News.

Unfortunately, faulty medical devices are placed in patients at an alarming rate. A study from the National Research Center for Women and families found that more than 437 million devices were recalled in 2010 due to fears that they might kill and permanently harm patients.

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April 12, 2011

Senate To Begin Investigation Of DePuy Hip Safety

This week the U.S Senate will begin its probe into medical device recalls and the connection between the massive DePuy Hip Replacement recall and the FDA's role in "protecting patient safety as part of the medical device approval process."

The DePuy Hip was recalled after numerous reports of metal shards breaking off the hip replacement and lodging themselves in patients' bodies. Although in many cases revision surgeries can correct the problem, many times permanent bone and tissue damage will occur.

If you have been fitted with a DePuy Hip, contact a knowledgeable DePuy ASR Hip System recall attorney. It is important to speak with an attorney to review your medical records and reports in order to determine the next best steps on your behalf.

Lawsuits have been filed in New Mexico and across the county accusing DePuy of manufacturing a defective product, failing to adequately warn doctors and patients of the potential for harm, and negligence.

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April 5, 2011

Zimmer NexGen Knee Recall Urged Due To Component Problems

Several physicians are urging a Zimmer NexGen Knee recall as the result of serious problems and component failures in the knee, requiring additional surgeries. The FDA has recalled some of the components following several lawsuits concerning the Zimmer NexGen CR-Flex knee failure rate. In fact, a prominent consultant for Zimmer recently went public stating that the Zimmer NexGen knee has significant problems and warned against its use.

If you have undergone knee replacement surgery, contact a Zimmer NexGen Knee attorney for more information regarding the Zimmer NexGen knees and its safety risks.

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December 27, 2010

Product Liability Claims Arising Out Of DePuy Hip Replacements

As reported in the Wall Street Journal - as the result of a loophole in the Food and Drug Administrations regulation of medical implants - many potentially faulty hip implants are on the market.

New drugs must undergo clinical trials before receiving FDA approval, however if a medical implant resembles a product already on the market, testing may not be required. This is what happened with the Articular Surface Replacement, a hip replacement device made by DePuy Orthopaedics.

Many patients who received the implant have developed pain. Upon replacement, physicians have located masses of dead tissue in the patient's thighs. Other patients claim high levels of cobalt ions in their blood, leading to fears of poisoning. According to a recent lawsuit, as the result of the DePuy hips, "many suffer severe pain, inflammation, death to surrounding tissue and bone, a partial or complete lack of mobility and the need for surgery to remove and replace the device, leading to a potentially increased risk of complications."

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November 15, 2010

Depuy Hip Recall Cases Escalate

Every day more and more cases are reported of patients injured after being fitted with the Depuy hip - an artificial hip replacement. According to reports, metal shards may break off of the hip replacement and lodge themselves in patients' bodies after being fitted. Although sometimes the problem can be resolved with subsequent surgery - many times permanent bone and tissue damage occurs. As one patient described, "It [the hip replacement] had been rotting away and I had been rotting away around it."

As a result of the malfunction, more than 93,000 implants have been recalled.

Sadly, medical devices often are placed on the market - and in our bodies - either without full knowledge of the risks and danger of serious injury or death to patients, or sometimes in spite of this risk.

In the Depuy hip implant cases, many doctors as well as the manufacturer continue to exploit patients who placed their trust in these devices. In certain instances, Depuy is paying surgeons who perform the necessary "revision" surgery removing the faulty device to have patients sign over the implant to them - and feeling obliged to follow doctor's orders, patients do so. However, in doing so, a patient may lose the only evidence of the faulty medical device and reduce the chances of proving a product defect. If you are asked to sign anything - politely decline. Your health care insurer is obligated to pay, and you are entitled to the procedure without having to sign any documents.

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August 16, 2010

Senator Questions Company's Response To Paid Consultant's Complaints About Zimmer Durom Cup

In a recent letter to Zimmer CEO David Dvorak, Senator Charles Grassley raised questions regarding how the company responds to criticisms concerning joint replacement products, including the Zimmer Durom Cup (also known as the Zimmer Durom Acetablular Cup), by physicians who are paid company consultants. Grassley has a history of seeking legislative transparency and cooperation concerning medical devices.

The Zimmer Durom Cup was introduced in the United States in 2006 as a hip replacement component. Intended to be an improvement, the cup has caused serious problems for many total hip replacement patients, including extreme pain and discomfort, and the need for additional surgeries. As a result, lawsuits have been filed across the country seeking damages - often claiming that that the hip replacement component is defective, and that Zimmer failed to provide adequate warnings or instructions about the proper use and surgical techniques for proper implantation.

Citing a recent New York Times article exposing growing disputes between physicians and orthopedic implant manufacturers, Grassley seeks answers about how problems are investigated. Many of these devices are approved by the Food and Drug Administration for sale without testing.

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August 8, 2010

New Reports Cite Safety Concerns Regarding Use Of Shoulder Pain Pumps

A recently issued report indicates that shoulder pain pumps - pumps used to deliver intra-articular pain medication during surgery - may be causing more harm than good. Anesthesiology News joins the New York Times, the FDA and hundreds of patients nationwide citing the potential for devastating and long-term shoulder injuries as the result of physician's using pain pumps during arthroscopic surgery.

Intra-articular injections have become increasingly common - as a way of providing post-operative pain management to shoulder and knee surgery. However, use following shoulder surgery is unapproved.

As early as 2007, reports of "post arthroscopic glenohumeral chondrolysis" (PAGCL) began emerging. PAGCL is a "severe, life-altering complication" involving significant shoulder pain and loss of shoulder motion in patients following arthroscopic shoulder surgery. PAGCL may cause permanent shoulder damage.

Last November the FDA warned, "The significance of injury to otherwise healthy young adult warrants notification to health care professionals." In January, an Oregon jury awarded $5.5 million to a patient who suffered chondrolysis.

Now, Anesthesiology News reports that the safety and efficacy of shoulder pain pumps "is anything but clear cut." As noted in the article, the effect of combining a well-established drug with a new application is a "new, untoward outcome."

Currently, at least 150 lawsuits have been filed linking the shoulder pain pumps and chondrolysis.

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July 3, 2010

Chondrolysis linked to intra-articular infusions

Medical Article Published in June of Nursing2010 by Joan Ferlo Todd, RN. Article discusses the injury caused to people who have underwent shoulder arthroscopy. Click on the link to read the full article: FDA Alerts and Notices :Harmful Medical Devices.

April 27, 2010

Who's Accountable For Faulty New Mexico Medical Devices?

A recent New York Times article posed the following question:

Who should be accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it?

We believe it's both.

We have seen hundreds of individuals throughout New Mexico who have had surgery, only to sustain injuries as the result of a physician implanting a defective product such as the Zimmer Durom Cup. Many parties may be responsible in such cases - including the company, the executives running the company, and even the physicians.

However, those people who are not responsible and must be compensated are the innocent patients who seek medical attention to improve their condition, only to sustain further injury.

In 2006, the Zimmer Durom Cup was introduced and intended to be an improvement over previous hip replacement products. However, rather than being an improvement, it caused significant pain and discomfort, as well as a loosening of the hip implants, requiring additional surgeries.

The use of defective Zimmer Durom Cups in hip replacement surgeries has led to dozens of lawsuits cropping up all around the country. Currently, at least 51 product liability lawsuits in 10 different states are currently pending against the Zimmer Durum Cup, a defective part that implanted during hip replacement surgery.

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