Date Issued: July 13, 2011

Audience:

•  Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence
• Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/or stress urinary incontinence
• Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence

Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine

Device:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.

Background:
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.

The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

In particular, the literature review revealed that:

• Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
• Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
• While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

Recommendations for Health Care Providers:

As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:

• Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
• 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 using surgical mesh.
• Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.

In addition, the FDA also recommends that health care providers:

• Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
• Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
• Consider these factors before placing surgical mesh:
  • Surgical mesh is a permanent implant that may make future surgical repair more challenging.
  • A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
  • Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
  • Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
• Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
• Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.

Additional patient information can be found on the FDA Consumer website.

Issued: October 20, 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.

Additional Patient Information can be found on the FDA Consumer website.

Federal Court

Parents can proceed with suit against hospital over child’s cerebral palsy in ’84
5/18/2010 3:59 PM By Michelle Massey 

Glorioso

 

U.S. District Court Judge Lance M. Africk is allowing the parents of a child born in 1984 with cerebral palsy to continue their case against the hospital that provided their son neonatal treatment.

The parents argue that the hospital was negligent by not informing them that their son received E-ferol, a vitamin E supplement which was later linked to health problems including cerebral palsy.

Gerald Michael Dileo, M.D., Linda Bartels Dileo, individually and on behalf of their son, John Lucas Dileo, III and John Lucas Dileo, III, individually, filed suit against Lakeside Hospital and Medical Center of Baton Rouge in federal court in New Orleans last year.

They claim their son was taken to the neonatal intensive care unit at Lakeside when he was born at 29 weeks gestation. During his four-month saty at Lakeside, “Luke” was given more than 1,250 units of E-ferol intravenously as a means to help prevent blindness.

The Dileos state that sometime around April 1984, two months after Luke began his regimen, the FDA discovered that the drug was causing severe health problems including to blindness, cerebral palsy and death.

The lawsuit states that Luke suffered form an intracranial hemorrhage, kidney failure, heart failure, coagulopathy, cerebral palsy and blindness.

Despite the amount of time that has passed since Luke received the vitamin, the family states they were not informed that the drug was known to cause the same serious complications that Luke suffered from until March 2008.

“Lakeside Hospital negligently and intentionally concealed the fact that Luke was administered E-ferol,” the lawsuit states.

In February, the court granted Lakeside’s motion to dismiss, finding that the claims under the Louisiana Unfair Trade Practices Act were preempted. But, in replies to the motion to dismiss, the Dileos argued that they also pleaded a state-law negligence claim that should not have been dismissed with the other claim.

Africk agreed with the family and is allowing the case to proceed on negligence claims.

The Dileos are seeking damages for physical pain and mental anguish, disability and handicap, lost earnings, permanent disabilities, lost enjoyment of life’s pleasures, and medical expenses. The parents are asking the court to award additional damages for their medical expenses, loss of services, society and other losses of consortium.

New Orleans attorneys Vincent J. Glorioso, Jr., Maria B. Glorioso and Vincent J. Glorioso, III of The Glorioso Law Firm are representing the plaintiffs.

The lawfirm’s website is “hugesettlements.com.”

A jury trial is requested.

U.S. District Judge Lance M. Africk is assigned to the case.

Case No. 2:09cv02838

For years, corporations have knowingly shipped toys with hidden dangers like small parts, loose magnets, asbestos, and other toxic chemicals until outrage from parents and civil actions forced regulators or manufacturers to act.

“As toys have become more sophisticated, so too have the risks associated with them,” said AAJ President Gibson Vance. “Protecting our children requires vigilance from everyone. Regulators, parents, manufacturers, and the civil justice system all play a part in keeping dangerous toys off store shelves.”

For example, earlier this year unsafe levels of cadmium were found in children’s jewelry, a toxic metal known to cause cancer and ranked as seventh on a federal list of the 275 most hazardous substances. An investigation found the origin of the metal was likely China, where the use of the toxin had been prompted, ironically, by the recent prohibition of using lead. The U.S. imports more than 30,000 tons of toys every year from foreign markets, accounting now for 95 percent of toys sold in the U.S.

While regulators lack the resources and staff to police the market, parents, consumer groups and the civil justice system have stepped into the void. In 2007, a popular CSI Fingerprint Examination Kit contained a powder found to contain up to five percent asbestos, potentially sending lethal tremolite asbestos into the air and into children’s lungs. Once the hazard was known, manufacturer CBS Consumer Products refused to remove it from store shelves as Christmas approached. Rather than wait for the Consumer Product Safety Commission to negotiate a recall, the Asbestos Disease Awareness Organization filed a civil action to stop sales of the kit.

The report, titled, “Playing with Safety: Dangerous Toys and the Role of America’s Civil Justice System,” details how the public learned about little known dangers hidden in today’s popular toys. The report can be found at www.justice.org/toys.

As the world’s largest trial bar, the American Association for Justice (formerly known as the Association of Trial Lawyers of America) works to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations. Visit http://www.justice.org/newsroom.

Being the daughter of a successful trial lawyer I grew up thinking you had to work long hard hours to achieve professional success. I now know this is true. However, I have come to learn that in order to be truly happy and fulfilled you must make sacrifices in your professional life in order to be successful in your personal, emotional and spiritual life.

There are no easy answers on how you do this. I certainly have not found any. I do know it doesn’t work if you try to find the time. Instead you have to make the time. Illustratively, I write this message very early in the morning on the day it is due. I was supposed to work on it yesterday after I had lunch with my grandmother and cousins (whom I don’t see often enough). I “should” have left after lunch and worked on this message. Instead I said, the hell with it, I am here, I made the time to get here, I must make the most of it and enjoy it now. So, I did. I wound up having a great time and got to spend quality time with relatives who are close to my heart but I seldom see.

So I sit hear now, tired but fulfilled. Happy in my personal life and somehow, seemingly succeeding to get this message written and to press on time.

In searching for a quote to give you as a “quick fix” I thought of Socrates’ admonition that the unexamined life is not worth living; and Emerson’s definition of success, “…to laugh often and much;…to appreciate beauty, to find the best in others; to leave the world a bit better whether by a healthy child, a garden patch or redeemed social condition…”. But the one quote I felt was most appropriate was from my father when he wrote “We trial lawyers in our never ending, full-time, all consuming quest for professional recognitions and financial success and in our commitment to and discharge of obligations to client and cause, all too often sacrifice the very quality of life which we seek for our clients and the loss of which we so eloquently and passionately lament to juries. How sadly ironic!

 As lawyers today, new or experienced, we are constantly defending our profession and ourselves as trial lawyers.  We’ve all heard the labels and jokes.  Not only do we defend ourselves to the general public but to our own clients, friends and families.  This aspect of our profession can drain our souls and weaken our heart’s desire to fight for a just cause.

 It never fails, after every ATLA convention, I come back to the office with a renewed sense of pride and enthusiasm about being a trial lawyer.  The annual convention in Chicago was no exception.  Just being around other trial lawyers who fight the same battles and truly care about what they do reminds me why I do what I do.  How nice to spend almost a week without the need to defend myself and with people who genuinely care to hear about my cases and causes.  It also reminds me that the satisfactions of being a trial lawyer do not come from our perception in the public eye nor from how much money we make.  For us to be truly satisfied with our profession we must look to the higher purpose.

 My message today is to challenge each of you to look to your higher purpose and find something or someone who reminds you of it.  Find something to turn to when defense counsel is about to wear you down or your client’s lack of appreciation begins to make you bitter.  We all have a client that we fall in love with because of the type of person they are and their cause.   Remember him or her in times like these.  Remember the causes you fight for which make putting up with the negative aspects of our profession worth it.  Remember other great trial lawyers who helped shape our justice system and be proud to be one of them.

 For me, I go to ATLA conventions, remember my clients, Shannon and Angela and turn to poems and speeches by great trial lawyers about our great profession.  I display my clients’ pictures and thank you cards on the mantel in my office so that I am always reminded of them and the cause we fought or are fighting.  I keep several words of wisdom in my top desk drawer for an emergency quick fix.  If you would like to read one of them, sign onto our list serve.  I’ll periodically put them under the subject “quick fix.” 

 For now, I leave you with these thoughts by one of our great members, Francis H. Hare, Sr. and written in 1976:

 There is something different and special about the trial lawyer.  You can tell it whenever you go in a courtroom and see any lawyer, old or young, good or bad, when his time comes to stand up and speak in behalf of his client, white or black, right or wrong.  Then, something happens that’s unlike anything else on earth; it is like the touch of Midas that turns dust into gold, or the miracle of electricity that turns a few strips of metal into a glowing flame of light.  There is a touch of everything wonderful in the advocacy of a lawyer for his client, in his effort to defend the right.  There is a dash of love in it, and there is a little sex appeal, and more than a little magic.  I have seen a shabby old lawyer that almost literally slept in the street come to court unshaved and disheveled and rise before a jury that came to scoff and remained to pray.  Every man who has lived the life of a lawyer knows what I mean and knows that there must be a source of this transformation of personality and power that touches an ordinary man with the pentecostal fire of an advocate.