A new study from the United Kingdom reveals what we’ve already suspected-namely that patients experiencing hip replacement failures and pain from their hip medical devices are on the rise. Unfortunately, no such data is available to us in the United States because we don’t have a medical registry database from which we can cull such valuable information. However, we can extrapolate from the British study and conclude the situation is no different in the United States. Such a conclusion is strengthened given the FDA’s acknowledgment that they’ve received more complaints about hip failures in the past six months than they did in the combined four year period previous to this year.
While most of the attention has been focused on the metal-on-metal hip devices that are causing problems and are failing at a high rate, there are still cases involving the Zimmer Durom cup. These Zimmer hips were never recalled but Zimmer patients continue to complain about pain and mobility issues with the Durom cup hip implants.

One might be tempted to think political science has nothing to do with the Catholic Church and the ongoing priest abuse crisis which has gripped the Church for nearly a decade now. If you read George Lakoff’s Don’t Think of an Elephant!: Know Your Values and Frame the Debate–The Essential Guide for Progressivesyou’ll find what I believe is the key to understanding why the Catholic bishops have been relatively unaccountable for their role in the abuse scandal.
One of Lakoff’s main ideas concern the fundamental difference between Republicans and Democrats in terms of governing style and the role of government in the lives of ordinary individuals. Lakoff believes that the Republicans have been successful in framing the debate about social issues because they use positive imagery to express their ideas. Take for instance the following: pro-life, death tax, and tax relief. Secondly, Republicans believe in the “strict father” model of governance. They’ve adhered to a model that demonstrates their belief that ordinary citizens seek a strict father figure who is always right and serves as a compass for the entire populace.
If you look closely, the Catholic bishops in the United States have adopted a similar approach. They speak authoritatively on many moral issues while at the same time questioning the authority of those who would call into question their actions concerning the abuse crisis. They are very quick to remind Catholics of their duty to obey and listen to them for, after all, they are the appointed shepherds of Christ and that role demands an unquestioning fidelity, not an openness to consider diverse points of view or alternative methods of accountability.
Perhaps that’s how the bishops have escaped any real accountability for their role in the priest abuse crisis. Yes, of course, Cardinal Law was forced to resign. Yet, apart from that incident, how many other bishops have been forced to resign? How many have faced real criminal charges? How many have been called to account for their actions with real consequences hanging in the balance?
Maybe a few bishops have read Lakoff’s book. If they have, they’ve followed his prescription to a tee. It’s proven helpful to them in avoiding any real accountability.

Since Common Pleas Judge Lillian Ransom has lifted her ban on the publication of Philadelphia Grand Jury documents concerning Monsignor William Lynn’s testimony, the media has been reviewing his testimony in anticipation of his pending criminal trial for child endangerment. What they’ve found reveals much about the inner workings of the Archdiocese of Philadelphia and the mindset of the priest in charge of reviewing and investigating sexual abuse claims for the then Cardinal Archbishop of Philadelphia Anthony Bevilacqua.
In one of his comments, Lynn told the grand jury, “”I just thought he wanted money,” in response to a sexual abuse survivor’s allegation that he had been molested by a priest.
Between 2002 and 2004, Monsignor Lynn made 14 appearances before the grand jury. His testimony is now a matter of public record and among 2,000 pages of grand jury evidence that will play a role in his criminal trial. Lynn’s callous disregard for the welfare of abuse survivors coupled with his protestations that the Vatican made his job difficult will also be on display during the criminal trial. In testimony during which Lynn couldn’t come up with a plausible answer for not doing something to protect children he would answer that the matter “fell through the cracks”. In another instance Lynn stated, “”Like any family, church family, you don’t always put all your dirty laundry out, so to speak.”
One of his colleagues who was also summoned to testify before the grand jury had similar difficulty explaining the Archdiocese’s lack of willingness to protect children. In one instance, now Bishop Cullen was pressed by the prosecutor regarding the veracity of one report. This is back and forth: “When the Rev. Robert L. Brennan was accused of misconduct with boys, the church sent him to a hospital for treatment. Parishioners were told he was on a religious retreat.
Asked about the cover story, Cullen conceded, “It’s not the truth.”
It was a lie, wasn’t it? prosecutors asked.
“You could call it that,” Cullen said.
Philadelphia, like Boston and Los Angeles before, is an archdiocese in extreme crisis. Perhaps they could take comfort with familiar words “The Truth will Set You Free”. However, it won’t be painless or easy.

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.

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.

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.

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.

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.

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.

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.