The FDA has categorized the Riata Defibrillator leads recall a Class I recall due to the potential for severe injuries related to the malfunction of the defibrillator leads. According to the FDA, the defibrillator may malfunction because the leads may penetrate the insulation leading to mechanical failure.
While the St. Jude Riata defibrillators were removed from the market last year, those who’ve had the implanted defibrillators may be at a greater risk of defibrillator malfunction and the FDA is urging consumers who have these defibrillators implanted to check with their physicians about monitoring and follow-up.

It’s what we’ve been saying for years now. The old artificial hip and knee devices were just as reliable and effective (perhaps more so) than the new ones. While slick PR and marketing campaigns employed by medical device companies tried to convince consumers and healthcare professionals otherwise, a new study has found that the older versions were indeed just as reliable, if not more so than the new devices.
According to the NY Times, “The study, which draws on data from Australia’s orthopedic registry, covered implants introduced from 2003 to 2007 and was published this week. The findings are significant for patients in the United States because many of the new designs, like so-called metal-on-metal hips, are widely used here. Those implants, which have both a ball and cup made of metal, are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do.
The Australian study showed that not a single new artificial hip or knee introduced over a recent five-year period was any more durable than older ones. In fact, 30 percent of them fared worse.”
Unfortunately, the new hip and artificial hip devices such as the Stryker hips, NexGen knee devices, Zimmer Durom Cup hips, and the DePuy ASR XL and DePuy Pinnacle hips may all be the result of marketing initiatives whose main purpose is profit. In these cases, I suspect good science and quality patient care have been sacrificed in favor of company profits. Medical device companies make higher profits when they are regularly adding new products to the market.

Former Roman Catholic Bishop Raymond Lahey’s criminal sentencing for his conviction regarding possession of computer child pornography resumes today.
Lahey, who has been incarcerated since pleading guilty to the charges in May, resigned as bishop of Antigonish following his computer pornography arrest in 2009. The sentencing phase has been going on since August.
Today’s testimony is scheduled to be filled by psychiatrists. Lahey’s defense lawyers are recommending leniency based upon the belief that the type of pornography Lahey possessed was less graphic than that of others convicted on similar charges.

A joint study authored by the American College of Obstetricians and the American Urogynecologic Society is now recommending that surgeons limit the use of the vaginal mesh medical device in high-risk patients who aren’t candidates for other types of medical interventions to remedy pelvic organ prolapse or female urinary incontinence.
The report was issued in the wake of months of news that the transvaginal or vaginal mesh medical device may cause serious health consequences and side effects for women who have the mesh implanted in order to treat these two medical conditions. In addition to findings that the mesh has a higher than acceptable failure rate which may require further surgeries, the vaginal mesh has not proven effective in treating either condition.
As a result of the negative findings, vaginal mesh lawsuits are mounting across the country as women are experiencing pain, discomfort and the prospect of future surgeries in order to repair the problems caused by the vaginal mesh.

It’s ironic that the two most recent and egregious cases of school sex abuse have occurred in states (New York and Pennsylvania) where reform of the civil statutes of limitations is sorely needed. In both states, sex abuse survivors are often barred from bringing legitimate sex abuse lawsuits because the cases are time barred by arbitrary and ineffective (at least in sex abuse cases) statutes of limitations. Originally, such statutes were rightly enacted in order to protect potential defendants from lawsuits arising out of claims that happened in the long ago past. However, in light of what we know about sex abuse cases as well as the psychological process most survivors endure after being abused, such statutes aren’t appropriate or just.
In light of the Penn State sex abuse scandal and the same saga being played out at Syracuse University it’s time both state legislators consider serious statute of limitations reform.

In the Netherlands, two boarding school teachers were convicted of molesting children. The following day, the presiding judge sent a letter to a Catholic member of Parliament urging more stringent hiring practices and thorough background checks. The judge’s communication with that member of Parliament resulted in 112 Catholic schools receiving a letter of appeal to take action to prevent the sexual abuse of schoolchildren. That was 1958.
Too often, we hear from Catholic bishops that “we didn’t know” or “how could we have known”. Yet, as is often the case, there were clear signs dating back decades that should have been impetus for change. Only years later does the public find out that people inside these institutions knew about warnings, signs, indications that something is amiss. Undoubtedly, the same will occur with the Penn State sex debacle. One could surmise it’s easier to feign ignorance than admit signs and warnings were ignored. That would make those who ignored such things complicit in the abuse of children.

A recent front-page article in the NY Times suggested that the latest hip procedure involving hip resurfacing or hip shaving is gaining popularity, especially among athletes. The resurfacing or shaving concerns a relatively quick surgical procedure that involves removing part of the top of the femur in order to reshape and/or remove bumps or grooves in the surface. In theory, this appears to be a good idea. However, like other hip procedures such as hip implants such as the DePuy ASR XL or the Zimmer hip implants, the resurfacing procedure has scant scientific evidence that shows it is effective in alleviating pain and increasing agility.
That’s really the issue with the recent spate of hip replacement lawsuits involving the Zimmer or DePuy ASR and Pinnacle hips. The marketing of these hips and procedures has progressed beyond the available scientific evidence. In other words, these new products are being sold without solid pre-marketing evidence that they actually work. Inevitably, this leads to hip implant recalls and lawsuits. The medical device industry has for too long been allowed to market products that don’t work and are actually more injurious to the patient than older methods and devices.
This may or may not prove true with the most recent hip resurfacing procedure. However, since there is scant evidence to suggest it works, why are these procedures approved for use on young athletes? That’s a good question for the FDA and the entire industry that seems to have placed profits over patient safety.

As the sexual abuse saga continues to rile religious institutions around the world, venerable Penn State University has been snared in this tragedy. Jerry Sandusky, a former Penn State defensive coordinator, has been charged with multiple charges involving the sexual abuse of minors. Most of the victims were in their early teens when the alleged abuse occurred. However, law enforcement officials fear that some abuse victims who have yet to come forward may be even younger.
Making matters worse, local Pennsylvania law enforcement officials have filed more charges against top-ranking Penn State administrators for lying to a grand jury about the sexual abuse as well as conspiracy to cover up the Sandusky sexual abuse.
This horrific news has left the collegiate community and its alumni deeply concerned and shocked. The weekend’s revelations point to the sad fact that child sexual abuse is a societal scourge for which we are all responsible and must take an active role in rooting out. Civil and criminal laws governing such behavior must be changed and toughened. The sexual exploitation and abuse of minors is a reflection on the relative health of the society as a whole. The news this past weekend doesn’t bode well for the present state of affairs.

The numbers are appalling. The FDA has admitted that it has received more than 11,000 complaints about metal-on-metal artificial hip replacements in the first nine months of 2011. That’s more than the last 3 years combined. The New England Journal of Medicine has reported that these types of hip replacements have a failure rate that is 3 times that of other types of hip replacements.
So, the real question is-why have the medical device companies marketed these new supposedly better hips when the old hips were working just fine? If you ask officials at the medical device companies, they’ll tell you that the metal-on-metal hips were designed for more active lifestyles and were supposed to last longer than the older ceramic hips. However, none of those claims were ever shown to be accurate. In fact, just the opposite is now closer to the truth.
So, what’s behind the marketing of these metal-on-metal failures? I suspect it comes down to marketing dollars and cents (notice, I didn’t say sense since there’s no sense to be made of this decision). In order to increase their market share, medical device companies who sell artificial hips have to grow their market share in order to increase their profit margins. They are always looking for what’s better, newer, more marketable. The interests of the patient aren’t part of that equation.
The medical device industry has to be forced to changed. There is just too much money to be gained and lost. The device companies won’t change unless they are forced to do it.

Bishop Robert Finn, Catholic bishop of the Diocese of Kansas City-St. Joseph has been indicted by a grand jury on criminal counts of failing to report child abuse. The Bishop’s indictment marks the first time in the United States that a current bishop has been charged criminally for his failure to report his knowledge of the sexual abuse of a minor.
The indictment should not be altogether surprising given the manner in which Bishop Finn flaunted the civil law in a sexual abuse case involving one of his own priests, Fr. Shawn Ratigan who remains in jail on criminal charges relating to computer child pornography. The Catholic Diocese has also been named as a defendant in civil sex abuse lawsuits concerning Ratigan’s alleged involvement with minors in his parish in the Diocese of Kansas City-St. Joseph.
According to multiple media reports, Finn was warned a year prior to Ratigan’s arrest by a Catholic nun who became concerned with Ratigan’s behavior and his attention to children. She sent a letter to the Bishop who said he never read the letter. Finn didn’t bother to inform his own Diocesan Review Board concerning allegations about Ratigan. Finally, when the police arrested him this past May, Finn’s lack of action came to the forefront.