TRANSVAGINAL MESH TVM HEALTH CONCERNS AND LITIGATION

Transcription

1 TRANSVAGINAL MESH TVM HEALTH CONCERNS AND LITIGATION

2 PRESENTED BY: THE PINKERTON LAW FIRM, PLLC The Pinkerton Law Firm is located in Houston, Texas. The firm specializes in mass tort litigation, including pharmaceutical and medical device litigation. The firm is knowledgeable in all facets of the Transvaginal Mesh (TVM) litigation. The firm carries a 100% success rate in mass tort ventures. Legal expertise, creativity, innovation, and most importantly, attentiveness to client needs, is what drives the firms success and separates us from other firms.

3 HISTORICAL TIMELINE OF SURGICAL MESH Surgical mesh has been used since the 1950 s to repair abdominal hernias. Gynecologists began using surgical mesh to repair POP in the 1970 s. In the 1990 s, gynecologists began using surgical mesh for treatment of SUI and transvaginal repair of POP. In 1996, the FDA cleared the first surgical mesh product specifically for treatment of SUI. In 2002, the FDA cleared the first surgical mesh product specifically for treatment of POP. From , various manufactures introduced transvaginal surgical mesh kits. From January 1, 2005 to December 31, 2010, the FDA determined that there were 3,979 reports of injury, death and malfunction related to transvaginal mesh implants. THE FDA BELIEVES THE OVERALL INCREASE IN THE NUMBER OF SERIOUS ADVERSE EVENT REPORTS IS CAUSE FOR CONCERN.

4 WHAT IS TRANSVAGINAL MESH? Transvaginal Mesh or TVM is a medical device that is permanently implanted into a woman s vagina. It is generally used to repair or strengthen weakened or damaged tissue related to menopause, child birth, trauma, organ prolapse, normal aging and/or hysterectomy surgery. The mesh is surgically implanted under the vaginal skin to provide strength to weakened or damaged tissue. Vaginal meshes are made from synthetic material and are permanently implanted, meeting the definition of a medical device.

5 WHEN IS TRANSVAGINAL MESH USED? Women may require surgical inter vention, including the implantation of transvaginal mesh, to reinforce weakened vaginal walls or to repair organ prolapse. Specific indications may include: Pelvic Organ Prolapse (POP): Occurs when the pelvic organs (bladder, uterus, or bowel) become weak that the organs fall or drop from their normal positions prolapsing or bulging into the vagina. Stress Urinar y Incontinence (SUI): Occurs when the pelvic floor muscles have insuf ficient strength to hold pelvic structures and organs in place resulting in involuntar y urination usually with sneezing, couching, and/or exercise. Hernia Repairs After Hysterectomy Surger y After Child Bir th

6 PELVIC ORGAN PROLAPSE POP POP occurs when the pelvic floor tissue becomes weakened or stretched, often seen after childbirth. This weakening or stretching causes the pelvic organs to bulge or prolapse into the vagina (apical prolapse), bladder (cystocele), uterus (procidentia), rectum (rectocele), or the bowel (enterocele). Some women may have POP but are asymptomatic. Others with POP will be negatively impacted by discomfort, pain, interference with sexual activity, urinary dysfunction, and defecation dysfunction. A woman s estimated life risk of POP is 30-50, with only 2% of women becoming symptomatic. There are both surgical and non - surgical options for treatment of POP.

7 THE FDA HAS NOT SEEN CONCLUSIVE EVIDENCE THAT USING TRANSVAGINALLY PLACED MESH IN POP REPAIR IMPROVES CLINICAL OUTCOMES ANY MORE THAN TRADITIONAL POP REPAIR THAT DOES NOT USE MESH, AND IT MAY EXPOSE PATIENTS TO GREATER RISKS. FDA C E N T E R FOR D E V I C E S A N D R A D I O L O G I C A L H E A L T H JULY 2011

8 THE CLINICAL EFFECTIVENESS OF SURGICAL MESH FOR TRANSVAGINAL REPAIR OF PELVIC ORGAN PROLAPSE HAS NOT BEEN DEMONSTRATED, SAID WILLIAM MAISEL, DEPUT Y DIRECTOR OF THE FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH WE BELIEVE PROPER STUDIES WOULD NEED TO BE DONE. BLOOMBERG REPORT SEPTEMBER 8, 2011.

9 STRESS URINARY INCONTINENCE SUI SUI occurs when stress or pressure is placed on the bladder, causing involuntary incontinence or urination. SUI affects an estimated 20-40% of women. Treatment may be conservative, such as exercise to strengthen the pelvic floor muscles, or surgical, such as mesh and non-mesh procedures.

10 WHO ARE THE MANUFACTURERS OF TRANSVAGINAL MESH? JOHNSON & JOHNSON Brand Names: Ethicon TVT, Gynecare TVT Sling, Gynemesh PS, Gynecare Prolift Mesh, Gynecare Prolene Mesh, Prolene Polypropylene Mesh Patch, Secur, and others. C.R. BARD Brand Names: Align, Avaulta Plus, Avaulta Solo Synthetic Support System, Faslata Allograft, Pelvicol Tissue, PelviSoft Biomesh, Pelvitex Polypropylene Mesh, Pelvilace, Uretex, Ugytex, and others. AMERICAN MEDICAL SYSTEMS Brand Names: Apogee, BioArc, Elevate, In-Fast, MiniArc, Monarc, Perigee, and SPARC. BOSTON SCIENTIFIC Brand Names: Advantage Sling System, Lynx Suprapubic Mid- Urethral Sling System, Obtryx, Curved Sling, Obtryx Mesh Sling, Prefyx Mid U Mesh Sling System, Prefyx PPS System, and others.

11 THE FDA MAKES CLEAR THAT THE COMPLICATIONS ASSOCIATED WITH MESH, WHICH IS PRODUCED BY A NUMBER OF MANUFACTURERS, HAVE NOT BEEN LINKED TO ANY SINGLE BRAND. FDA D OES NOT CLEAR ANY MANUFACTURERS FROM HARM RELATED TO T VM

12 ACCORDING TO BLOOMBERG, JOHNSON & JOHNSON SOLD A VAGINAL MESH IMPLANT FOR THREE YEARS BEFORE U.S. REGULATORS APPROVED THE DEVICE. MOST SURGEONS WOULD PROBABLY NOT HAVE USED A COMPLETELY NEW PRODUCT IF THERE WAS NO OVERSIGHT. MANUFACTURER FAST-TRACKED TVM TO THE MARKET WITHOUT FDA APPROVAL

13 The following problems have been linked to TVM: Fistulas; Infections; Internal bleeding; Mesh erosion, exposure, extrusion, or protrusion into the vagina, bladder, intestines, and uterus; Mesh shrinkage; Mesh migration; Organ perforation; Pain; Pain during intercourse, known as dyspareunia; Punctures to the bladder, blood vessels, bowels and other organs in the lower abdomen; Recurrence of POP, SUI or both; Recurrent organ prolapse; Urinary tract issues, including painful urination; Vaginal wall narrowing; Vaginal scarring and shrinkage; Neuro-muscular problems; and Emotional problems. MANY PATIENTS HAVE CLAIMED THAT T VM SURGERIES HAVE CAUSED THEM INTERNAL INJURIES. F ROM , T H E F D A N O T E D T H A T IT H A D R E C E I V E D A N D C O N F I R M E D A L M O S T 4, P A T I E N T R E P O R T S OF A D V E R S E A F F E C T S F R O M T V M S U R G E R Y. P A T I E N T S R E P O R T E D M O D E R A T E TO S E V E R E P R O B L E M S A N D 7 D E A T H S WERE A S S O C I A T E D W I T H S I D E E F F E C T S F R O M T V M S U R G E R Y.

14 ON JULY 13, 2011, THE FDA CONCLUDED THAT SERIOUS COMPLICATIONS ASSOCIATED WITH SURGICAL MESH FOR TRANSVAGINAL REPAIR OF POP ARE NOT RARE. FDA C E N T E R FOR D E V I C E S A N D R A D I O L O G I C A L H E A L T H JULY 2011

15 What are the health and safety concerns linked to T VM implantation, as identified by the FDA? Patients that undergo POP repair with T VM are subjected to mesh-related complications that are not experienced by patients that undergo traditional surgery for POP. Adverse events associated with TVM can be life - threatening. Mesh-associated complications are not rare at least 10% of women with T VM implantation experience vaginal erosion within 12 months. More than half of the women that experience vaginal erosion related to T VM implantation return to the operating room at least once to repair the harm. Mesh contraction, vaginal shortening, tightening, or vaginal pain is increasingly reported. New onset of SUI has been reported to occur more frequently with T VM implantation than with traditional repair. T VM implantation for vaginal apical prolapse is associated with a higher rate of reoperation than with traditional repair. T VM implantation for POP is associated with higher erosion rates than more traditional repairs rates as high as 4% in 23 months. HEALTH AND SAFETY CONCERNS LINKED TO TVM T HE FDA RECENTLY COMPLETED AN EXTENSIVE REVIEW OF T HE L ITERAT U RE AND IDENTIFIED 8 S ERIOU S HEALT H AND S AFET Y CONCERNS RELAT ED TO S U RGICAL MESH IMPLANT S. T HE FDA P U B L ISHED IT S FINDINGS IN J U LY

16 IN PARTICULAR, THESE PRODUCTS ARE ASSOCIATED WITH SERIOUS ADVERSE EVENTS, INCLUDING VAGINAL MESH EROSION (ALSO CALLED EXPOSURE, EXTRUSION OR PROTRUSION), A COMPLICATION WHICH CAN REQUIRE MULTIPLE SURGERIES TO REPAIR AND MAY RESULT IN CONTINUED SEQUELAE (E.G., PAIN) EVEN AFTER MESH REMOVAL. COMPOUNDING THE CONCERNS REGARDING ADVERSE EVENTS ARE PERFORMANCE DATA THAT FAIL TO DEMONSTRATE IMPROVED CLINICAL BENEFIT OVER TRADITIONAL NON-MESH REPAIR, PARTICULARLY FOR TRANSVAGINAL APICAL AND POSTERIOR REPAIR. WHILE THE LITERATURE SUGGESTS AN ANATOMIC BENEFIT TO ANTERIOR REPAIR WITH MESH AUGMENTATION, THIS ANATOMIC BENEFIT MAY NOT RESULT IN SUPERIOR CLINICAL OUTCOMES, AND THE ASSOCIATED RISK OF ADVERSE EVENTS SHOULD BE CONSIDERED. FDA WARNING

17 THE SCIENTIFIC COMMUNITY ILLUSTRATES THE DANGERS OF TVM THE NEW ENGLAND JOURNAL OF MEDICINE Found higher rates of surgical complications and postoperative adverse events with T VM implantation surgery as compared to traditional surgeries. Our results highlighted the need for a careful evaluation of surgical [T VM] innovations, which are often adopted in the absence of data from clinical trials. We found higher scores of stress incontinence and higher frequency of new stress incontinence after [T VM]. Found higher rates of sexual pain with T VM implantation AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS 15.6% of surgical mesh patients developed erosions. This figure was so significant (an unacceptably high rate of vaginal mesh erosion ) that enrollment into the study was discontinued, as the erosion figure was outside of tolerable limits for the researchers. T VM patients illustrated a high reoperation rate of 8.5%. Cure rates for T VM patients were reported as low as 43.7%.

18 JOHNSON & JOHNSON STOPS SELLING CONTROVERSIAL VAGINAL IMPLANTS, BUT THE HARM HAS ALREADY BEEN DONE TO THOUSANDS OF WOMEN. JOHNSON & JOHNSON STATED THAT IT HAD NO INTENTION TO COMMERCIALIZE T VM PRODUCTS IN THE FUTURE, CALLING THIS STEP A GLOBAL DISCONTINUATION. REUTERS EXPECT OTHER MANUFACTURERS TO FOLLOW THE LEAD. JULY 11, 2012

19 WHAT SHOULD YOU DO IF YOU HAVE HAD TVM IMPLANTATION? Contact your doctor and determine what device you had implanted (Device I.D.). Contact your doctor and request an evaluation of your post -operative status. Collect your medical records related to your procedure and post -surgical care. Have a medical expert review your case to determine if you have had any complications, even if you do not have any symptoms, related to your TVM surgery. THE PINKERTON LAW FIRM, PLLC CAN DO ALL OF THIS FOR YOU AT NO CHARGE. The Pinkerton Law Firm, PLLC is experienced in mass tort litigation and has a 100% success rate not a guarantee it s just a historical fact. No other firm can offer the service offered at The Pinkerton Law Firm, PLLC you will deal with experienced attorneys and trained professionals. The Pinkerton Law Firm, PLLC will work hard to obtain the highest compensation possible for our clients and to ensure that all of our clients are compensated for their injuries in the quickest manner possible

20 CONTACT THE PINKERTON LAW FIRM, PLLC NOW! Time is of the essence. You have a limited amount of time to file your claim. Take action now or you may loose your right to recover in the future. Go to ChadPinkerton.com or Call