Monthly Archives: August 2011

Vaginal Mesh Lawsuit

While trans vaginal meshes are manufactured by many different companies, the results are the same across all manufacturers-the mesh doesn’t work and causes serious complications for those who’ve had the unfortunate experience of having one surgically implanted. Medical devices companies such as C.R. Bard, Mentor, Boston Scientific, Gynecare (Johnson & Johnson), Covidien, Ethicon (J&J), and AMS all market these failed products.
If you or a loved one has experienced difficulties with a vaginal mesh, you should consult your physician. If you’re contemplating vaginal mesh surgery, talk to your doctor about alternatives. The data shows that these medical devices are causing more problems than they are solving.

Archdiocese of Chicago Priest Abuse Settlement

The most recent Catholic priest abuse settlement in Chicago was not finalized until the Archdiocese agreed to publish the names of priests credibly accused of molesting children. For most survivors, the publication of the priests’ names is the biggest victory in their struggle for justice.
A week after the Archdiocese of Boston published a list of its own priests who’ve been accused of sexual molestation of children, the Archdiocese of Chicago has agreed to do the same thing as a result of a lawsuit settlement. Both Boston and Chicago are victories for survivors who’ve suffered the trauma and mental anguish that is so inextricably linked to sexual abuse.

Hip Replacement Implant Recall News

A front-page NY Times article published yesterday noted that reports of adverse events concerning hip implants, particularly metal on metal hips, are at an all time high. The FDA, according to the Times, has received 5,000 Hip Implant complaints since January. That number is greater than the number of hip complaints the federal agency had received in the previous four years combined.
While the FDA has begun a full-fledged review of all metal-on-metal hip implants, including data on failure rates, the number of adverse effects and failed hip implants will in all likelihood continue to increase. Two factors contribute to this increase 1) hip replacement surgery is one of the most common procedures in the US and 2) There are 500,000 metal on metal hip replacement patients, according to one estimate. Of course, we don’t have hard data on these numbers because the US doesn’t maintain a medical device registry, a database of medical devices which contains among other things, failure rates and adverse event reports on hi replacements.

Drug Ads Don’t Meet FDA Guidelines

A new study shows that most pharmaceutical advertisements in industry journals don’t meet the FDA guidelines. According to the study as reported in the LA Times, “Only about 18% of the ads complied with all 20 FDA guidelines and about 58% didn’t calculate serious risks of the drugs, including death.
About 49% of the ads may not have adhered to at least one FDA-ordered item and about 33% might not have complied because of incomplete information. About 48% didn’t have references that could be confirmed and almost 29% couldn’t adequately quantify effectiveness.”
Now, what does that tell us? I’d bet that the same holds true for medical device ads and marketing materials as well. While we can bemoan the industries’ lack of compliance with federally mandated guidelines, such complaining is ultimately useless and benefits no one. The real issue is that most pharmaceutical and medical device firms aren’t afraid of skirting FDA regulations. They know that the benefits far outweigh the risks when they decide to market their products. Unfortunately, the FDA is a paper tiger that has no real regulatory clout. It’s not completely the agency’s fault either. The federal government has never properly funded the FDA and so we’re left with companies that would rather put profits over the welfare of ordinary people. If you don’t believe that, please tell me why the United States is one of the few developed countries in the world that has no medical device registry system by which implanted medical devices are tracked and monitored? The FDA can only do so much and must work within constrictive budgetary guidelines. In the end, such political decisions put consumers at risk while allowing large pharmaceutical and medical device companies flaunt the rules with impunity.

FDA Open to Public Comments on Medical Devices

After releasing its draft on the premarket approval process for medical devices, the federal agency will accept public comments until November 14th. The FDA has scheduled a public hearing on the matter for September 16, 2011.
The FDA decided to re-examine the manner in which medical devices are approved and placed on the market after numerous artificial hip devices, particularly the metal-on-metal hip devices, have experienced high failure rates and led to a dangerous medical condition known as metallosis.
Presently, many new medical devices are “fast tracked” for approval based on the fact that the new device closely resembles previously approved devices in terms of design and function. Opponents of the so-called fast tracking system note the high failure rates and the numerous recalls that have taken place in the last few years to argue that the system is flawed and puts patients and consumers at unnecessary risk.

Philly Judge Orders Cardinal to Appear for a Competency Hearing

Common Pleas Court Judge M. Teresa Sarmina has ordered retired Philadelphia Archbishop Anthony Bevilacqua to appear before her for a competency hearing so that she can determine whether the 80-year-old Cardinal is able to appear as a witness in Monsignor William Lynn’s criminal conspiracy trial involving the sexual abuse of minors in the Archdiocese.
While Bevilacqua gave extensive grand jury testimony in 2003-04 which resulted in the Philadelphia grand jury report. A subsequent grand jury report recommended criminal charges against Monsignor William Lynn and other Philadelphia priests. Bevilacqua’s testimony is crucial because his grand jury testimony is not admissible unless and until defense attorneys are allowed to cross examine the Cardinal.
While defense attorneys for Cardinal Bevilacqua have maintained that he is infirm and incapacitated, recently revealed photos show him engaged during public gatherings in 2009 and 2010.
It’s not clear what the competency hearing will produce. However, it marks an important step in the right direction as far as holding high ranking Church officials accountable for their conduct and supervision of abuse allegations and the handling of those priests accused of child sex abuse.

FDA Questions Vaginal Mesh Implants

In the wake of numerous reports of serious complications as well as no evidence that the meshes actually provide the medical benefit for which they are marketed, the FDA is re-assessing the trans-vaginal sling or mesh that has been used to treat urinary incontinence in women.
The vaginal mesh is designed to improve pelvic organ prolapse wherein a woman’s bladder, uterus, or rectum slips out of place. Not only was the vaginal mesh unable to provide release for pelvic organ prolapse, the medical mesh was shown to potentially cause serious complications such as tissue erosion and vaginal shrinkage.
“We are reassessing our regulatory options for this product,” said Dr. William Maisel, a chief scientist for the agency’s medical devices arm. Maisel said options include requiring clinical trials to be conducted and changing the classification of vaginal mesh implants to require formal pre-market approval applications. “We feel that the routine use of mesh for transvaginal POP treatment is not necessary.”
The situation is serious enough that the FDA has called for a September meeting of outside experts to assess the situation including a potential vaginal mesh recall. It’s estimated that some 75,000 receiving the vaginal mesh last year. The medical device was approved for use in 1996 to treat female incontinence and in 2002 the vaginal mesh was approved for treatment of pelvic organ prolapse.

A Tough Balancing Act for the FDA

Yesterday, The Wall St. Journal published an op-ed piece by the commissioner of the Food and Drug Administration Margaret Hamburg. As to be expected, it was an apologia for the beleaguered federal agency. It should come as no surprise that it was published in the Wall St. Journal rather than the NY Times. However, to be fair, the Journal has been balanced in its reporting of FDA shortcomings and controversies, especially concerning their 510(k) approval process for medical devices.
Commissioner Hamburg does not have an easy task in overseeing the FDA. On one hand, it’s critical for an appropriately expedient approval of drugs that benefit the consumer and may save lives. On the other hand, patient safety requires exacting scientific standards that are often at odds with the marketing and business plans of the large pharmaceutical and medical device companies. Of course, it would be tremendously helpful to the FDA if all pharmaceutical and medical device companies considered safety issues as vital to their own bottom line as the profits made from the sale of these products. There exists an inherent tension and at times, a conflict of interest within these companies. That tension and/or conflict exists between the scientific research divisions and the marketing divisions. Unfortunately, in some instances the marketing division influences and dominates the research. In these cases, it falls to the FDA to step in and ensure patient safety. Perhaps the best and most recent example of such tension can be found in the marketing and sale of the metal-on-metal hip replacements, some of which have failed-the DePuy ASR XL and DePuy Pinnacle hips are the most obvious instances of this. In light of this, the FDA has intervened and called for a thorough review of these metal-on-metal hip replacement devices. For some patients who’ve already suffered through revision surgeries, FDA action has come too late.

Panel Calls for More FDA Scrutiny of Medical Devices

A federal panel is urging the FDA to take a more detailed look at the approval process for medical devices. The recommendation comes in the wake of a spate of medical device recalls and failures in the past two years. The FDA has already taken some action regarding hip replacement medical devices after a rash of hip replacement failures and recalls that involved the DePuy ASR XL and DePux Pinnacle metal-on-metal hip devices.
The 12 member panel at the Institute of Medicine, a part of the National Academy of Sciences, is expected to carry significant weight and influence the FDA’s ultimate decision. The panel has recommended that the FDA review and revise its 510(k) review process under which the FDA approves medical devices without human studies if the device is “substantially equivalent” to others already on the market. That simpler approval process, known as a 510(k) approval, generally doesn’t evaluate the safety and effectiveness of a product in the way that is required for most drugs. This quicker approval process has led to criticism and resulted in device failures and recalls in the last few years.