Thursday, July 28, 2011

Savannah TVM Mesh Information; Lawyer

Last week I  wrote about the recent FDA report regarding TVM failures. Here is the information that has been available in 2008:



Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.


Nature of the Problem

Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.


Recommendations
Physicians should:
  • Obtain specialized training for each mesh placement technique, and be aware of its risks.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

Thursday, July 21, 2011

Savannah: Transvaginal Mesh Patch Failure

Transvaginal Mesh Patch Failure

A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:

  • Erosion of the vaginal tissue
  • Infection
  • Bleeding
  • Pain
  • Urinary problems such as incontinence
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation (puncturing) from surgical tools during mesh implantation
Less frequent problems included
  • Return of POP
  • Neuro-muscular problems
  • Vaginal scarring/shrinkage
  • Emotional problems

FDA Alerts and Research Find Transvaginal Patches Unsafe

2011 FDA Alert – Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also finds the risky surgical mesh treatment of POP to be no more effective than traditional treatment.

2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect including:
  • 7 times the risk of bladder perforation
  • Nearly twice the risk of urinary incontinence (loss of bladder control)
  • 3.2 percent of women required follow-up surgery to correct problems
2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.

2010 Study Published – A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.

2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.
Over 200 Lawsuits Filed Already
More than 200 women across the United States have filed lawsuits against three of the makers of transvaginal mesh patches:
  • C.R. Bard
  • Johnson & Johnson’s Ethicon
  • American Medical Systems
Complications have been reported for several other manufacturers of surgical mesh as well including:
  • Boston Scientific Scimmed
  • Sofradim
  • Caldera
  • Mentor Corporation
What Should You Do?

If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.

Savannah Bicycle Accident News for July, 2011

Savannah’s bicycling faithful say they hope a new state law requiring motorists to be more careful will help curb accidents, but they acknowledge the driving habits of their fellow cyclists also pose a hurdle to minimizing the number of mishaps.

Reports of accidents between motorists and cyclists in 2009 and 2010 fault bicyclists about 48 percent of the time and motorists about 39 percent of the time. The rest of the time there’s either no fault assigned to either or both are blamed.

Those are numbers determined by outside groups that pore over police reports every year and often assign blame to a cyclist even after an officer faulted the motorist, said Sean Brandon, Savannah’s director of mobility and parking services.

Source: http://savannahnow.com/news/2011-07-18/savannahs-cyclists-motorists-both-take-accident-blame#.TihXkGFi_Lk 

One killed, one hurt in Savannah crash

Savannah-Chatham police are investigating the head-on collision of two SUVs on Shipyard Road Tuesday night that left one man dead and a second injured.

Charles Rockett, 31, of the 400 block of Hunt Drive, was pronounced dead at Memorial University Medical Center after the 2002 Acura MDX he was driving southbound on Shipyard Road crossed the centerline and collided with a 1999 Lexus LX470, said Julian Miller, police spokesman.

John Rathbun, 59, of the 400 block of Moon River Court, who was driving the Lexus, also was transported to Memorial for treatment of non-life threatening injuries.

http://savannahnow.com/latest-news/2011-07-20/one-killed-one-hurt-savannah-crash#.TihXMmFi_Lk

Sunday, July 17, 2011

Do PI Lawyers Know something about Social Media (Twitter) that other Attorneys Don't?

Image representing Twitter as depicted in Crun...Image via CrunchBaseI'm a lawyer who works for injured consumers. 100% of my practice is devoted to work on the Plaintiff's side of the aisle.

Last week I attended the annual convention for the American Association for Justice, which was held in New York for a nearly one week period. The lineup? More than 2,000 lawyers. Bill Clinton speaking at one event. Quite literally a 100+ seminars, meetings, sessions, and networking events. A huge vendor area.

Now, if you are a social marketing "guru" touting twitter as the be-all, end-all for success for attorneys to gain clients, "leverage" yourself and all those other BS jargon terms, you'd guess that AAJ New York was fertile ground for tweets, tweet ups (almost impromptu meetings  between attorneys), and "twitpics" (pix taken around town with the ever present AAJ lanyard front and center on your chest).
 You'd be wrong.

No Twitter. Yes, you read that right. Go to Twitter.com and search for #AAJ. Not "AAJ" because that has a different meaning in the far off middle east.

What do you find? Zilch. A handful of tweets by a vendor or two, maybe a smattering of "just got to NYC" tweets.

The AAJ Convention had a multitude of events, not just seminars. Lawyers were spread across two massive hotels. To me it seemed like just about every hotel bar and restaurant was filled to capacity with attorneys during meal hours and after the CLE events ended. There were after hours events, invite only shindigs, and general meetings for candidates for office. Twitter as a means to convey information of meetups? MIA. 



Why? I know why. I've known "why" for some time. At least as to personal injury attorneys, they have seen first hand that not many of us drink the Kool-Aid when it comes to Twitter allegedly making the phone ring and the caseload increase. It doesn't. Is Twitter a waste of time then? For PI attorneys, the proof is there - if you base it on usage. Twitter simply does not work for PI Attorneys. And by work, I mean - making the phone ring, making a firm web page work, increasing a caseload.

So what has been realized perhaps by those attorneys who attended was simply this - in the arena of personal injury litigation, nothing beats in person, real life networking. Number one on the list at any AAJ convention is doing what comes naturally to many successful injury lawyers - shaking hands, listening to and telling stories, and connecting. In person. 

I know what some of you are thinking - PI attorneys must be Neanderthals! Nope. PI attorneys have long been on the cutting edge of technology in many areas. Attorneys like me have learned Google and adwords. I (and others) have learned that the quality of a good website or blog will work wonders on your practice. Private lists for groups of lawyers are fertile areas for connections, work sharing, and even gossip.

PI attorneys have been early adopters of products in the courtroom, for motion practice, depositions, site inspections, and client management. PI attorneys use voice recognition software, SMS texting systems for certain segments of their clientele, and have long ago mastered YouTube.com.

Twitter simply is not there yet for attorneys in personal injury practices, and the AAJ convention is Composite Exhibit A. Twitter added zero value to AAJ. Information was still shared mind you among the 2,000 attorneys.



If an attorney insists on jumping in to the very large and for the most part undefined "social media" arena, I suggest that you start at ground zero. Look at your website. Update it. Make it rise to at least page two on google.com for search results. Then, work on making a blog that is worthwhile. To me a blog is the best tool by far for your firm. We have three blogs and I'm very happy with each.  Next, if you must jump in to Facebook. LEARN GOOGLE ADWORDS. You don't trust your closing argument to your receptionist do you? I've gone through google's adwords certification.Then and only then do you try Twitter.  

So - you ask - what are you doing on it?  For me, the Twitter account I use allows me to publicize my blogs by simply using Twitter Feed. In my niches my firm follows FDA related news, so the near instant access to news helps me. Lawyers, industry professionals, and reporters who are in the area of unsafe pharma products and supplements are worth following.  I enjoy reading news information from my home state of Florida through another twitter account (my main account is @ageorgialawyer).

My unsolicited advice to personal injury attorneys and even the Plaintiffs' bar - those who think Twitter is an essential part of your tool kit for marketing is this: It's not. It may never be. Anyone who suggests it is, hey that is great. Just don't pay for someone to help you with Twitter.

Don't expect Twitter to even be on the radar screen at smaller TLA groups in some states. Because the most basic was to 'have a conversation' is to do just that - but in person.



 
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