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Talcum Powder Lawsuits Continue

Johnson and Johnson is once again under the gun for a product and this time it is the houehold staple Johson and Johnson's Baby Powder. Who would have believed it. Additional lawsuits are being added to the ongoing MDL.

Four additional talcum powder cancer lawsuits claiming ovarian cancer have been sent  to the multidistrict litigation in New Jersey. A multidistrict litigation  consolidates large numbers of similar lawsuits for easier management under one judge for pre-trial discovery and bell weather trials. Thousands of talcum powder  ovarian cancer lawsuits have been filed against Johnson & Johnson in state and federal courts nationwide.

Missouri's 22nd Circuit Court in St. Louis, Missouri has  approximately 1,000 talcum powder cases and similar complaints are pending in New Jersey, Delaware and California. More talcum powder lawsuits were consolidated in New Jersey MDL 2738.

Recent jury verdicts against Johnson & Johnson for talcum powder lawsuits have been high, awarding millions of dollars to victims.

In May 2017, a St. Louis jury delivered a $110.5 million verdict against Johnson & Johnson in a talcum powder lawsuit filed by Lois Slemp of Virginia, according to the St. Louis Post-Dispatch.

After the recent $110.5 million verdict, J & J posted a statement on its website:

Johnson and Johnson can add it's talcum powder products to the long list including vaginal mesh, hernia mesh, and other products. It is important for physicians to understand these anre not medical malpractice or store negligence  lawsuits but, product liability lawsuits against the manufacturer.Baby Powder. Who would have believed it.

 

How Can Talcum Powder Cause Ovarian Cancer

 

I lawsuit was recently won by a woman who claimed that Talcum Powder gave her ovarian cancer. The woman passed away from ovarian cancer but, the facts provided were convincing enough for the jury to decide on a 72 million dollar settlement.

J&J's Baby Powder labels do advise that it's meant for external use only. The studies on perineal talcum-powder use and ovarian cancer risk is not new.

.It appears that the particles can travel to the ovaries when used on the pelvic area and sit there for years. Over time the constant irrietation results in cancer producing cells.

If you believe that you or a loved one's diagnosis of ovarian cancer is due to years of using Talcum Powder please see

www.classactionlawyernetwork.com for a talcum powder lawyer.

 

 

Florida Medical Referral Service Helps The Injured and Personal Injury Lawyers

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Injury Doctors Network is helping the injured and injury lawyers by providing medical doctors who understand insurance codes and your PIP claims.

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Auto accident Injuries are our  speciality:

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Finding A Vaginal Mesh Doctor

The vaginal mesh has become the latest topic of debate with FDA warnings, vaginal mesh lawsuits and stories of pain suffering and destroyed lives. To this date many doctors are still putting them in and it appears very difficult to locate a doctor that understands the problems.

Many doctors are afraid to touch a woman with a vaginal mesh and women are suffering from incorrect medical information The famous vaginalmeshhelpline.com social worker speaks to women on a daily basis and has been able to locate doctors in some states.

 

Commitee on Gynecologic Practice Discusses vaginal Mesh, Vaginal mesh helpline Reports

 

Written by Vaginal Mesh Helpline on May 18, 2012. Posted in Vaginal Mesh Blog

 

Vagina mesh helpline is constantly looking for new information for our readers.

 

Committee on Gynecologic Practice, Vaginal mesh overview. Vaginal Mesh Helpline Updates and News.

This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

 

Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse

 

Abstract: Since 2004, use of synthetic mesh has increased in vaginal surgery for the treatment of pelvic organ prolapse. However, concerns exist about the safety and efficacy of transvaginally placed mesh. Based on the currently available limited data, although many patients undergoing mesh-augmented vaginal repairs heal well without problems, there seems to be a small but significant group of patients who experience permanent and life-altering sequelae, including pain and dyspareunia, from the use of vaginal mesh. The American College of Obstetricians and Gynecologists and the American Urogynecologic Society provide background information on the use of vaginally placed mesh for the treatment of pelvic organ prolapse and offer recommendations for practice.

 

Since 2004, use of synthetic mesh has increased in vaginal surgery for the treatment of pelvic organ prolapse (POP). However, concerns exist about the safety and efficacy of transvaginally placed mesh. Surgeons who perform these procedures may have many questions related to a U.S. Food and Drug Administration (FDA) Safety Communication released in July 2011 (1), which updates a 2008 FDA Public Health Notification (2), as well as published reports describing variable experience with mesh. The purpose of this joint document developed by the American College of Obstetricians and Gynecologists and the American Urogynecologic Society is to provide background information on the use of vaginally placed mesh for the treatment of POP and offer recommendations for practice. This report does not address the subject of synthetic mesh used for abdominal or minimally invasive sacrocolpopexy or for midurethral slings to treat stress urinary incontinence.

 

How does the U.S. Food and Drug Administration currently regulate surgical mesh products?

 

Surgical mesh is a medical device, currently regulated by the FDA as Class II Special Controls. Instead of the premarket approval review process reserved for Class IIIdevices, Class II devices are introduced to the market by way of the regulatory pathway of Section 510(k) of the Federal Food, Drug and Cosmetic Act. In the 510(k) Premarket Notification Program (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/How

toMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm), a manufacturer attempts to demonstrate that a new device is “substantially equivalent” to a predicate device (ie, a similar Class IIdevice already on the market). In making such a determination, the FDA reviews a comparison of the new device and the predicate device in terms of intended use and product design. This review typically addresses labeling and performance data, including material safety, mechanical performance, and animal testing, but, for some devices, it may also include clinical data.

 

In 2001, the FDA reviewed the first surgical mesh indicated for repair of POP and found it substantially equivalent to surgical mesh indicated for hernia repair. This finding was done without clinical data, and, since then, many subsequent mesh products have been cleared for the same indication without clinical data. Currently, an estimated 100 synthetic mesh devices or kits have been cleared by the FDA for use in surgery for POP, but only approximately 20% are actively marketed and sold. Modification of mesh devices continues. Compared with existing mesh products and devices, new products should not be assumed to have equal or improved safety and efficacy unless clinical long-term data are available. However, the FDA is currently re-evaluating the process it uses to evaluate mesh intended for vaginal repair of POP and is considering whether to reclassify it from Class II to Class III, which would allow the FDA to require clinical trials comparing procedures with mesh with those in which mesh is not used.

 

As with all medical devices, the adverse events associated with use of surgical mesh should be reported inthe FDA’s Manufacturer and User Facility Device Experience database (http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm). This reporting is voluntary for physicians and mandatory for manufacturers, but underreporting of complications is acknowledged. The complication rate related to vaginally placed mesh is not fully known because of incomplete knowledge of the total number of adverse events and the total number of vaginal mesh delivery systems that have been implanted.

 

What outcome data exist for vaginal placement of synthetic mesh forpelvic organ prolapse?

 

Vaginal mesh kits were first marketed to urologists and gynecologists as a way to improve success rates for POP repairs with native tissue, but without well-designed trials to establish the safety and efficacy of these devices. The body of literature is increasing for vaginal mesh, yet, case series and prospective cohort studies greatly outnumber randomized trials. These smaller series document good short-term surgical success in the hands of individual surgeons, but longer follow-up of procedures performed by surgeons from multiple centers is lacking.

 

Several systematic reviews draw on a similar pool of studies of vaginal mesh repairs, but these studies are based on short-term follow-up and have variable outcome measures. Systematic reviews by the Society of Gynecologic Surgeons and the World Health Organization-sponsored International Consultation on Incontinence found weak evidence for improved anterior anatomy when vaginal prolapse repairs were performed with synthetic mesh compared with native tissue (3–5). There are insufficient data on the use of mesh for the posterior or apical compartments. Although the risk of mesh erosion varied, it was a risk that did not exist for native tissue repairs.

 

One systematic review evaluated 30 studies totaling 2,653 patients who had undergone one of several apical prolapse kit repairs (6). Success was defined variably and ranged from 87% to 95%, with follow-up ranging from 26 weeks to 78 weeks. Another systematic review analyzed the complications and reoperation rates for surgical procedures specifically performed to correct apical POP: 1) native tissue vaginal repairs, 2) abdominal sacrocolpopexy, and 3) vaginal mesh kits (7). In this review, the rate of reoperation to correct complications as well as the total reoperation rate was highest for vaginal mesh kits compared with vaginal native tissue and abdominal repairs, despite shorter overall follow-up.

 

A 2010 Cochrane review evaluated 3,773 participants in 40 trials of different surgical procedures for POP and concluded that mesh grafts improved anterior anatomy more than native tissue repairs, but the abdominal approaches offered the best anatomic result (8). There was a higher rate of complications associated with vaginal mesh compared with native tissue vaginal repairs, including a 10% mesh erosion rate.

 

In Canada, the Society of Obstetricians and Gynaecologists of Canada (SOGC) reviewed 18 published studies of vaginal mesh for POP, of which 9 were observational or case series with 3–12-month follow-up, and only 1 was a randomized trial (9). Anatomic cure was typically defined as less than stage II of the POP quantification system (leading edge of prolapse within 1 cm of hymenal ring) and reported as 79–100%. The SOGC recommended that transvaginal mesh procedures be considered novel techniques that can demonstrate high rates of anatomic cure in uncontrolled short-term case series. It advocated surgeon training specific to each device before vaginal mesh repair for POP is performed and called for thorough individual patient counseling regarding the risks and benefits of these surgical procedures.

 

In a recent randomized controlled trial (RCT) of 389 women assigned to anterior mesh or anterior colporrhaphy, higher success rates based on a composite outcome of subjective absence of a bulge and anatomic stage 0 or stage I prolapse were seen with anterior mesh (60.8%) compared with colporrhaphy (34.5%) at 1 year (10). Ratesof intraoperative bladder injury and hemorrhage were higher in the mesh group, and de novo stress incontinence also was higher (12.3% versus 6.3%). Surgical reintervention for mesh exposure was 3.2%.

 

What are the complications of vaginal mesh in surgery for pelvic organ prolapse?

 

The complications of vaginal mesh in surgery for POP range from transient pain and small mesh erosions to larger vaginal mesh exposures or extrusions or perforations into the bladder or bowel (11). Some complications can be managed in the office, but others that involve bladder and bowel injury, fistulae, abscess formation, and debilitating pain may require repeat surgery under anesthesia. Table 1 is adapted from the SOGC review and reports additional case studies and randomized trials of mesh for POP published since the Canadian review that analyzed literature published through May 2010. In the previously described reviews, mesh erosion was the most common complication, occurring in 5–19% of vaginal repairs using mesh (2–11% in the SOGC report). Some acknowledged risk factors for mesh erosion include urogenital atrophy and smoking, and vaginal or topical estrogen and smoking cessation may be helpful for affectedwomen (12). Overall, complication rates from vaginal mesh range from less than 1% to 15%; however, because most of the studies cited in the SOGC report were observational and of short follow-up, there is concern that the complication rates could be higher than those estimated from these reviews.

Table 1. Range of Percentage of Mesh-Related Complications

Reported

Complication

Range Based on

Case Series

(%)

 

Range Based on

Randomized

Controlled Trials

(%)

Mesh erosion

(exposure)

1–18.8

 

5–19

Buttock, groin,

or pelvic pain

2.9–18.3

 

0–10

De novo dyspareunia

2.2–15

 

8–27.8

Reoperation*

1.3–7.6

 

3.2–22

*Does not include reoperation for stress urinary incontinence.

 

Data from Transvaginal mesh procedures for pelvic organ prolapse. SOGC Technical Update No. 254. Society of Obstetricians and Gynaecologists of Canada. J Obstet Gynaecol Can 2011;33:168–74; Carey M, Higgs P, Goh J, Lim J, Leong A, Krause H,et al. Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised controlled trial. BJOG 2009;116:1380–6; Nieminen K, Hiltunen R, Takala T, Heiskanen E, Merikari M, Niemi K, et al. Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J Obstet Gynecol 2010;203:235.e1–235.e8; Miller D, Lucente V, Babin E, Beach P, Jones P, Robinson D. Prospective clinical assessment of the transvaginal mesh technique for treatment of pelvic organ prolapse-5-year results. Female Pelvic Med Reconstr Surg 2011;17:139–43; Jacquetin B, Fatton B, Rosenthal C, Clave H, Debodinance P, Hinoul P, et al. Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study. Int Urogynecol J Pelvic Floor Dysfunct 2010;21:1455–62; Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol 2008;111:891–8; Iglesia CB, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL,et al. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 2010;116:293–303; Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME.Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol 2011;117:242–50; Maher C, Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: CD004014. DOI: 10.1002/14651858.CD004014.pub4; and Altman D, Vayrynen T,Engh ME, Axelsen S, Falconer C. Anterior colporrhaphy versus transvaginal meshfor pelvic-organ prolapse. Nordic Transvaginal Mesh Group. N Engl J Med 2011;364:1826–36.

 

Several recent retrospective reports provide longer follow-up. One reported that vaginal erosion rates for anterior mesh repairs ranged from 7% to 20% (13) with one half of the cases managed with vaginal estrogen and antibiotics and the other half requiring surgical mesh removal (partial or complete). Another reported 5-year follow-up in a cohort of 85 women after vaginal mesh surgery (14). The overall rate of mesh exposure was 18.8% with 56% (9/16 patients) requiring reintervention for partial mesh excision. Anatomic success rate (defined as less than POP quantification system stage II) at 5 years was 66.7%. One report evaluated a cohort of 355 women after vaginal mesh procedures (15). Eighteen percent of the women developed pelvic muscle dysfunction and pain; of these, one quarter continued to have symptoms after 6 months of therapy.

 

Pelvic pain, groin pain, and dyspareunia can occur with pelvic reconstructive surgery regardless of the use or nonuse of mesh. However, a complication unique to mesh is erosion (also described as exposure or extrusion), which seems to be the most common complication, and may sometimes present several years after the index procedure. There are increasing reports of vaginal pain associated with changes that can occur with mesh (contraction, retraction, or shrinkage) that result in taut sections of mesh; 11.7% of patients were found to have retracted mesh in a large retrospective multicenter cohort (16). Some of these women will require surgical intervention to correct the condition, and some of the pain appears to be intractable.

 

Risk factors for developing intractable pain after vaginal mesh placement are not understood. Mesh grafts for abdominal hernia repair, which are placed in clean surgical planes with intervening tissue layers, can cause pain in one quarter of individuals 1 year after repair; in one half of these cases there was functional impairment (17). Hernia mesh also is known to undergo retraction (18), and pain persists in patients at 5 years (19). Mesh grafts in the vagina are placed in a clean–contaminated field with a single vaginal incision, and the “arms” of some mesh configurations pass into the obturator internus and levator ani muscles. Shrinkage or contraction of mesh around these structures or excess tension on the mesh arms can cause vaginal pain in some individuals. All vaginal surgery can potentially affect vaginal length and function; however, the addition of synthetic mesh could make the vagina, a cylindrical organ that expands and contracts, less pliable and perhaps more prone to pain or dyspareunia. One ultrasound study evaluating women at 3 months after anterior vaginal mesh placement found severe contraction or shrinkage, defined as a decrease of more than 50% of the size of the mesh, in 9.3% of patients (20).

 

Based on the currently available limited data, although many patients who undergo mesh-augmented vaginal repairs heal well without problems, there seems to be a small but significant group of patients who experience permanent and life-altering sequelae, including pain and dyspareunia, from the use of vaginal mesh. These problems emerge in studies with longer follow-up, similar to hernia literature. Large-scale registries are urgently needed to understand the number of mesh-augmented vaginal procedures that are being performed with POP repair and how many of them are associated with vaginal mesh complications as well as to balance the risks and benefits of mesh-augmented vaginal procedures.

 

How effective and safe are native tissue repairs for pelvic organ prolapse?

 

Native tissue repair may have better success rates than previously thought. However, like repairs augmented with mesh, native tissue repairs also may be associated with complications, including pain, dyspareunia, granulation tissue formation, and recurrences, all of which may also require subsequent intervention. Older definitions of surgical success from prolapse repairs were more anatomically based (eg, no prolapse beyond -1 cm from the hymenal ring) and may not be the best assessment of outcome compared with newer definitions of surgical success, which include the absence of bulge symptoms or rates of retreatment (21). Previous studies used definitions of success that may have been too stringent. A 2001 randomized trial of three methods of anterior wall repair, including native tissue, ultralateral anterior colporrhaphy, and absorbable vaginal mesh, reported success rates (based on anatomic success definitions) of only 30–46% (22). These low success rates were frequently cited as a reason why innovations such as vaginal mesh were needed to decrease failure rates. The original data from this study were recently reanalyzed using modern outcome measures (a composite of anatomic outcomes and subjective success), and the revised success rates for the three arms of this RCT were comparable, with 89% of women having no objective prolapse beyond the hymen. Overall, only 5% of those with 1-year follow-up data were symptomatic, and there were no reoperations either for recurrence or complications at 1 year (23). Patient “success” is more than an anatomic outcome; subjective patient-oriented success and quality of life outcomes need to be considered as well. The ideal method for comparing vaginal surgical procedures using native tissues and those using vaginal mesh kits remains an RCT with an adequate length of follow-up and blinded assessment of outcome using several complementary outcome measures, including cost–benefit analysis.

 

Who are the best patients for transvaginally placed mesh?

 

Few data exist as to who are the best patients for transvaginally placed mesh. Pelvic organ prolapse vaginal mesh repair should be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk, such as individuals with recurrent prolapse (particularly of the anterior compartment) or with medical comorbidities that preclude more invasive and lengthier open and endoscopic procedures. The approach to the repair of POP should take into account the patient’s medical and surgical history, severity of prolapse, and patient preference after education regarding the benefits and risks of the surgical and nonsurgical alternatives.

 

How can patient safety be maximized by physicians who perform pelvic organ prolapse repairs with vaginal mesh?

 

Surgeons performing complex pelvic floor reconstructive surgery should have adequate experience and training in native tissue repairs as well as repairs using mesh augmentation specific to each device, should have a thorough understanding of pelvic anatomy, and should be able to counsel patients regarding the risk/benefit ratio on the use of mesh compared with native tissue repairs. In its 2011 Safety Communication, the FDA identified transvaginal placement of surgical mesh for POP repair as an area of “continuing serious concern” (1). The FDA’s 2011 Safety Communication reaffirmed its 2008 recommendation that clinicians inform patients about the potential for serious complications and the effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh, and provide a copy of the patient labeling from the surgical mesh manufacturer if available. Clinicians should be vigilant for possible adverse events from mesh. Additionally, the FDA made several new recommendations for health care providers, including that they recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications; that they choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and nonsurgical alternatives; and that they consider that the removal of mesh because of mesh complications may involve multiple surgical procedures 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.

 

As a surgeon, one should have a thorough understanding of pelvic anatomy and have training in the technique. Patients need to be counseled that there are alternative native tissue repairs and that synthetic mesh is permanent. Some patients may not realize that vaginal bleeding, pain, and dyspareunia may be related to vaginal mesh, and such reports should prompt a thorough vaginal examination, and an examination under anesthesia if needed.

 

Summary

 

Mesh kits for repair of POP were first marketed to urologists and gynecologists as a way to improve success rates for POP repairs with native tissue, but without well-designed trials to establish the safety and efficacy of these devices. However, prolapse surgical procedures, with or without mesh, are not always successful.

 

With the use of a composite of anatomic success, patient-oriented improvement and satisfaction, and total reoperation rates, success rates of native tissue repairs may be higher than previously thought. Based on available data, transvaginally placed mesh may improve the anatomic support of the anterior compartment compared with native tissue repairs; however, there are insufficient data on the use of mesh for the posterior or apical compartments. The risk/benefit ratio for mesh-augmented vaginal repairs must balance improved anatomic support of the anterior vaginal wall against the cost of the devices and increased complications such as mesh erosion, exposure, or extrusion; pelvic pain; groin pain; and dyspareunia.

 

Recommendations

 

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society make the following recommendations for the safe and effective use of vaginal mesh for the repair of POP:

 

Outcome reporting for prolapse surgical techniques must clearly define success, both objectively (anatomic results) and subjectively (patient satisfaction or symptomatic return of bulge causing bother or requiring reoperation). Complications and total reoperation rates (for recurrence or complications) should be reported as outcomes.

Pelvic organ prolapse vaginal mesh repair should be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk, such as individuals with recurrent prolapse (particularly of the anterior compartment) or with medical comorbidities that preclude more invasive and lengthier open and endoscopic procedures.

Surgeons placing vaginal mesh should undergo training specific to each device and have experience with reconstructive surgical procedures and a thorough understanding of pelvic anatomy.

Compared with existing mesh products and devices, new products should not be assumed to have equal or improved safety and efficacy unless clinical long-term data are available.

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society strongly support continued audit and review of outcomes, as well as the development of a registry for surveillance for all current and future vaginal mesh implants.

Rigorous comparative effectiveness randomized trials of synthetic mesh and native tissue repair and long-term follow-up are ideal.

Patients should provide their informed consent after reviewing the risks and benefits of the procedure, as well as discussing alternative repairs.

 

References

 

Food and Drug Administration. FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Silver Spring (MD): FDA; 2011. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Retrieved July 27, 2011.

Food and Drug Administration. FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Silver Spring (MD): FDA; 2008. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Retrieved June 2, 2011.

Murphy M. Clinical practice guidelines on vaginal graft use from the society of gynecologic surgeons. Society of Gynecologic Surgeons Systematic Review Group. Obstet Gynecol 2008;112:1123–30.

Brubaker L, Glazener C, Jacquentin B, Maher C, Melgrem A,Norton P, et al. Surgery for pelvic organ prolapse. In: 4th International Consultation on Incontinence. Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence; 2008 Jul 5–9; Paris, France. p. 1273–320. Available at: http://www.icsoffice.org/Publications/ICI_4/files-book/comite-15.pdf. Retrieved June 2, 2011.

Sung VW, Rogers RG, Schaffer JI, Balk EM, Uhlig K, Lau J,et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Society of Gynecologic Surgeons Systematic Review Group. Obstet Gynecol 2008;112:1131–42.

Feiner B, Jelovsek JE, Maher C. Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic review. BJOG 2009;116:15–24.

Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complication and reoperation rates after apical vaginal prolapse surgical repair: a systematic review [published erratum appears in Obstet Gynecol 2009;113:1377]. Obstet Gynecol 2009;113:367–73.

Maher C, Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: CD004014.DOI: 10.1002/14651858.CD004014.pub4.

Transvaginal mesh procedures for pelvic organ prolapse. SOGC Technical Update No. 254. Society of Obstetricians and Gynaecologists of Canada. J Obstet Gynaecol Can 2011;33:168–74.

Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. Nordic Transvaginal Mesh Group. N Engl J Med 2011;364:1826–36.

Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery. Int Urogynecol J Pelvic Floor Dysfunct 2011;22:3–15.

Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW,Norton PA, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol 2008;199:688.e1–688.e5.

Rardin CR, Washington BB. New considerations in the use of vaginal mesh for prolapse repair. J Minim Invasive Gynecol 2009;16:360–4.

Miller D, Lucente V, Babin E, Beach P, Jones P, Robinson D.Prospective clinical assessment of the transvaginal mesh technique for treatment of pelvic organ prolapse-5-year results. Female Pelvic Med Reconstr Surg 2011;17:139–43.

Aungst MJ, Friedman EB, von Pechmann WS, Horbach NS, Welgoss JA. De novo stress incontinence and pelvic muscle symptoms after transvaginal mesh repair. Am J Obstet Gynecol 2009;201:73.e1–73.e7.

Caquant F, Collinet P, Debodinance P, Berrocal J, Garbin O, Rosenthal C, et al. Safety of trans vaginal mesh procedure: retrospective study of 684 patients. J Obstet Gynaecol Res 2008;34:449–56

Bay-Nielsen M, Perkins FM, Kehlet H. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Danish Hernia Database. Ann Surg 2001;233:1–7.

Schoenmaeckers EJ, van der Valk SB, van den Hout HW, Raymakers JF, Rakic S. Computed tomographic measurements of mesh shrinkage after laparoscopic ventral incisionalhernia repair with an expanded polytetrafluoroethylene mesh. Surg Endosc 2009;23:1620–3.

Berndsen FH, Petersson U, Arvidsson D, Leijonmarck CE, Rudberg C, Smedberg S, et al. Discomfort five years after laparoscopic and Shouldice inguinal hernia repair: a randomised trial with 867 patients. A report from the SMIL study group. SMIL Study Group. Hernia 2007;11:307–13.

Velemir L, Amblard J, Fatton B, Savary D, Jacquetin B. Transvaginal mesh repair of anterior and posterior vaginal wall prolapse: a clinical and ultrasonographic study. Ultrasound Obstet Gynecol 2010;35:474–80.

Bradley CS, Nygaard IE. Vaginal wall descensus and pelvic floor symptoms in older women. Obstet Gynecol 2005;106:759–66.

Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol 2001;185:1299–304; discussion 1304–6.

Chmielewski L, Walters MD, Weber AM, Barber MD. Reanalysis of a randomized trial of 3 techniques of anterior colporrhaphy using clinically relevant definitions of success. Am J Obstet Gynecol 2011;205:69.e1–69.e8

 

Copyright December 2011 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

 

ISSN 1074-861X

 

Vaginal placement of synthetic mesh for pelvic organ prolapse. Committee Opinion No. 513. American College of Obstetricians and Gynecologists. Obstet Gynecol 2011;118:1459–64.

 

Stryker recall Rejuvenate Modular, ABG II modular-neck hip stems.

Stryker Recalls Hip Implants

By Cole Petrochko, Associate Staff Writer, MedPage Today

The orthopedic device manufacturer Stryker has recalled two modular-neck hip stems because of a potential for fretting and corrosion that may result in tissue pain and swelling.

The recall affects all lots of the Rejuvenate Modular and the ABG II modular-neck hip stems.

The company initiated the recall after post-market surveillance data showed that the fretting and corrosion risk “may be predictive of a trend,” according to an FDA statement.

Hip stems are attachments to artificial hips that allow the device to better fit a patient’s anatomy.

In an FAQ release, the company noted that “patients may present with symptoms of pain and swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis.”

Stryker has set up a toll-free phone number — 1-888-317-0200 — to deal with questions about the recall. The number is effective in the U.S. and Canada only. For a Stryker recall lawyer see DePuyHipreplacementhelpline.com who has just launched a Stryker Hip Replacement Helpline. 1 8oo 733-5342

Vaginal mesh Updates, Vaginal Mesh lawyers, Vaginal mesh Doctors, Everyone is in on It

The Vaginal mesh has been the center of attention these days with lawyers on T.V and doctors trying to give women hope and confidence again. Women are filing lawsuits for defective devices and J & J has pulled four of the Gynecare mesh off the market. The mesh is a problem. At the  vaginal mesh helpline, vaginalmeshhelpline.com  women are getting support and help by a female medical social worker who is attempting to locate a urogynecologist or surgeon for them with much difficulty. The vaginal mesh helpline also put women in touch with a lead lawyer or a lawyer who only refers to a lead lawyer approved by the helpline. 888 529-7222.  Vaginal mesh and bladder slings attorneys are aggressively investigating and litigating cases on behalf of women throughout the United States who have suffered severe complications as a result of the Gynecare (Ethicon) Prolift Anterior, Posterior, and Total Pelvic Floor Repair Systems, Bard Avaulta Pelvic Floor Repair Systems, Boston Scientific Uphold and Pinnacle Pelvic Floor Repair Kits, American Medical Systems (AMS) Apogee, Perigee and Elevate Prolapse Repair Systems and related mesh products. At the same time doctors are offering mixed reactions to women with severe mesh complications.

Below is an article of interest about the vaginal mesh with one of the most open minded medical reviews I have seen. However, discussion of the horror stories  with the vaginalmeshhelpline.com  MSW  reveals the complications are very severe and life altering.

with Jane Harrison-Hohner, RN, RNP and Laura Corio, MD

Monday, August 1, 2011

Vaginal Mesh: New FDA Warnings

As a healthcare provider one really knows that a serious concern has arisen when it makes the evening news. But in my book, nothing tops the alarm bells that go off when a medical product suddenly appears on the TV screen at my gym followed by the phone number of an out of state legal firm soliciting for clients. This just happened when I was on the cross trainer last week so it seemed important to share the most accurate information I could find about the newest FDA warnings for vaginal mesh.

 

You may have had some type of surgical mesh used for, say, a hernia repair. This use goes back to the 1950s. In the 1970s GYN surgeons began using the mesh designed for hernia repairs to help reinforce tissues in the vagina to repair pelvic organ prolapse (POP). Up to 50% of women may experience some type of prolapse (Maher, 2010), but only a few percent will need surgical treatment. In POP, either the bladder collapses down from the upper wall of the vagina (cystocele), the rectum pushes through the lower wall of the vagina (rectocele), or the top of the vagina collapses down the vaginal canal. Yet it was not until 2002 that there was an FDA approved product designed specifically for repairs of pelvic organ prolapse.

 

Mesh can also be used to elevate the neck of the bladder to treat urinary stress incontinence (SI). Stress incontinence presents with loss of urine with coughing/sneezing/jumping and may be present in 24% of women (Minassian, 2008). Surgeons began using mesh to treat stress incontinence in the 1990s. The FDA approved a mesh specifically for SI use in 1996.

What is the vaginal mesh and what are the problems?

There are four types of surgical mesh: non-absorbable polyester or polypropylene, absorbable synthetics, animal tissues, and combinations of the above. Most GYN and female urology surgeries use the polyester or polypropylene type of mesh

Once a drug or device is approved for use, the FDA has a variety of ways in which problems with a product can be reported. For example, you may have noticed the MedWatch option on some WebMD pages, which allows consumers to report suspected problems. Unfortunately, some women (and their doctors) may not connect a new gynecological problem to a past surgery. One member of our staff shared the following personal experience.

 

I had this repair done about 10 or so years ago for rectocele. The approach was vaginal and surgical mesh was used. It seemed to be perfect initially, however, as time has gone on, I have had pain issues. I get paroxysmal cramping pain along the wall of the vagina where the repair was made. It lasts from 5-20 minutes, and is bad enough to wake me from a sound sleep. These episodes have increased over time.

 

I have mentioned it to two doctors and one blew it off, and the other looked puzzled and had no ideas to offer. I have not mentioned it to my newest doctor because it seemed pointless — until I saw the FDA article.

 

Manufacturers are required to keep track of possible adverse outcomes linked to their products. In the first few years there were 1105 reports of possible problems with mesh used for prolapse repair, or for urinary stress incontinence surgery. In the last three years there have been an additional 2874 adverse reports (FDA, 2011).

 

According to a just-published FDA report (2011), the most common problems reported when mesh was used for repair of prolapse were:

Erosion or protrusion of the mesh from the soft tissues

Pain, including pain with intercourse

Infections in the area of the mesh

Urinary tract problems

Bleeding from the mesh site

Damage to nearby organs

Who is most likely to have problems with mesh repairs for POP?

According to one of the largest analyses of almost 12,000 women, about 10% of women experienced mesh erosion within a year after surgery. This figure includes both synthetic mesh and biologic types (Abed, 2011). Individual studies have found rates that were as low as 1.2 %, as in a group of 446 women derived from a private uro-gynecology clinic (Stephanian, 2008).

Some risk factors have been described which might predispose a woman to have mesh erode into vaginal tissues. Among 322 women who had a 24 month follow up after mesh repair for POP, having a hysterectomy at the time of POP surgery, and being a smoker increased risk for mesh problems (Cundiff, 2008). When the mesh was placed through a vaginal approach (as opposed to an abdominal incision) there were more mesh complications (Visco, 2001). Other risks may include: increasing age, low estrogen levels, size of mesh implant, and variations in surgical technique (Mistrangelo, 2007). Keeping one’s uterus and use of a mesh just for rectocele repair seemed to decrease risk (Caquant, 2008).

 

How long does it take for the problems to be apparent?

Mesh problems tend to develop at least a month after surgery for POP (Caquant, 2008) as opposed to the immediate recovery period. The average time for an erosion of mesh to occur may vary by surgery. For those with an abdominal incision for POP, it took 15.6 months versus 4.1 months with a vaginal incision placement, for mesh erosion to be a problem.

 

Is there a cure?

If a woman has developed pain, or infection, or mesh erosion after a POP surgery, the usual treatment is excision of the mesh via vaginal incision. Thirteen such women were referred to a uro-gynecology clinic for mesh removal. It took an average of two surgeries per patient to remove mesh, and repair any resultant prolapse (Margulies, 2008).

What about mesh used for urinary stress incontinence (SI) repair?

While some 33% of POP surgeries involve mesh placement, over 80% of SI surgeries utilize mesh placed through a vaginal incision (FDA, 2011). Often mesh is used as a sling to elevate and support the urethra. Currently the FDA is reviewing the scientific data on the use of mesh for urinary stress incontinence repair for a later report to the public.

What are the problems reported after vaginal sling surgery for SI?

As discussed earlier, there are several types of materials that can be used for surgical repairs. One of the older synthetic meshes used to make a sling (Mersilene®) had a reported erosion rate of 8% requiring surgical removal. While this material has had decreased use in the past 15 years, some of the women with erosion were 20 years out from their SI surgery (Wohlrab, 2009)

In one group of 179 women with complications from synthetic mesh materials, 125 had a sling placed under the urethra for repair for SI. The most frequent problems were bladder outlet obstruction, pain, and narrow mesh/tape exposure. The mesh complications for SI surgery were found to be different than those for POP repair (Skala, 2011).

A thorough search of published reports of sling surgery complications yielded over 1200 articles. Some complications were more related to surgery (e.g., perforation, bleeding) while others would appear later (e.g., urge incontinence, urinary tract infections, and voiding problems). The number of complications also varied with the type of surgery (Daneshgari, 2008). Not all surgeries utilized synthetic mesh; however for the years examined (1995-2007) mesh was an increasingly popular choice.

 

How are SI mesh problems treated?

There can be several options for treatment. In one study of 21 patients where vaginal erosion occurred, all were treated with a re-sewing of the vaginal tissues. For 18 women this included surgery for mesh removal. When there was only a small area of erosion, three women were treated with topical estrogen vaginal cream after the stitching. Only two patients needed a second surgery to resolve the problem (Kuhn, 2009)

In the event of vaginal erosion of sling material, the sling should be removed. If only a small area is involved, only the exposed mesh need be removed. The area is then re-sewn (Delorme, 2010)

Unfortunately, if the sling is excised, symptoms can return. Following the removal of a mesh sling, some 36% of women developed new symptoms of urinary stress incontinence (Tijdink, 2011).

On September 8-9, 2011 the FDA will be meeting to review the studies evaluating safety and effectives of mesh placed through vaginal incisions. Repair of both POP and SI will be discussed. Until such time as new guidelines might be published, the FDA asks that women (and their doctors) report suspected problems with GYN mesh use to Med Watch.

 

Additionally the FDA recommends the following to women who are planning, or have had, mesh surgery for prolapse (FDA, 2011):

Before surgery:

Be aware of risks associated with POP repair using a vaginal incision

Understand that a surgery with mesh might require additional surgery to correct mesh problems–and that in a few cases even repeat surgery may not cure the problem.

Ask your doctor about other POP treatment options. If they recommend mesh, have a clear understanding of why this is the preferred option.

 

After surgery:

 

Continue with routine check ups

Notify their doctors if they begin to have persisting vaginal bleeding/discharge, pelvic or groin pain, or pain with sex

…. However most doctors are not recognizing the problems are real,  especially  the ones that put the mesh in according to the helpline…..

Let your doctor know you have mesh. This is especially important if you are planning to have another abdominal/pelvic surgery.

If you are unsure if mesh was used , ask your surgeon if you had a mesh placed during your POP repair. If you have a mesh and need help call the Vaginal Mesh Helpline 1 888 529-7222

Vaginal Mesh News. Urinary Incontinence, Bladder sling Alternative

For women with Urinary incontinence we found this alternative to the vaginal mesh and also the Bladder Sling. As you know Vaginal mesh has been the focus of many lawsuits and controversies. J&J just pulled four Gynacare products off the market and changed the label for the fifth just recently : See article below on a new method to help:

BACKGROUND: Stress urinary incontinence (SUI) is the most common type of urinary incontinence, affecting 15 million women in the United States alone. SUI is the involuntary leakage of urine which occurs during periods of increased intra-abdominal pressure (“stress”).

CAUSE: The primary cause of SUI is inadequate support of the bladder resulting in leaks during activity. SUI affects women of all ages, including approximately 25% of women age 30-59 years, particularly those who have delivered at least one baby vaginally

Other factors that may worsen stress urinary incontinence include: urinary tract infection, obesity, smoking, diabetes, excessive consumption of alcohol or caffeine, and sports like running or tennis. (Source: Mayo Clinic

COMMON SYMPTOMS: If you have SUI, you may experience urinary leakage when you: cough, sneeze, laugh, stand up, lift something heavy or exercise.(Source: Mayo Clinic)

SURGICAL OPTIONS:

Injectable bulking agents: Collagen, synthetic sugars or gels may be injected into tissues around the upper portion of the urethra. These materials increase pressure on the urethra, improving the closing ability of the sphincter. Because this intervention is relatively noninvasive and inexpensive, it may be an appropriate treatment alternative to try before other surgical options.

Open retropubic colposuspension: This procedure is often used to treat women with stress incontinence. Sutures attached either to ligaments or to bone lift and support tissues near the bladder neck and upper portion of the urethra.

Sling procedure: In this procedure most often performed in women, the surgeon uses the person’s own tissue or a synthetic material to create a “sling” that supports the urethra. Slings for men are used less frequently, but this surgical approach is under investigation. A recently developed technique using a mesh sling has proved effective in easing symptoms of stress incontinence in men. (Source: Mayo Clinic)

RENESSA: Renessa is a non-surgical treatment for women who experience SUI. The Renessa treatment uses a small device which your physician passes through your urethra. It involves the controlled heating of microscopic tissue sites at the base of your bladder, after which the device is immediately removed.

There are no catheters, bandages or dressings to change. It takes about 45 minutes. The full effect of treatment is typically seen within 60-90 days.

Dr Looks At vaginal Mesh, Vaginal mesh Doctors

Dr. Goldman Talks Mesh Removals

Apr 4th, 2012 | By Jane Akre | Category: Medical News

 

Dr. Howard Goldman, Cleveland Clinic

 

A woman who I am planning to do a Patient Profile on called me the other day. She had surgical mesh partially removed at the Cleveland Clinic with urologist, Dr. Howard Goldman, two weeks ago. She was on her way back to the Cleveland Clinic in extreme pain. She had been on the same antibiotic for two years and now had a high white cell blood count, she said. This woman’ didn’t sound good and cried on the phone but she refused to go to an emergency room because, she said, they didn’t know how to treat her.

 

I wanted to follow up with Dr. Goldman’s office to find out how he feels about partial mesh removals. Last week Dr. Goldman’s videos (here) featuring a partial mesh removal “excision” and a mesh “incision,” where the mesh is cut to relieve tension, shown on YouTube, made their way to MDND and many readers complained believing that contributes to a worse outcome. While some doctors who advocate full mesh removal would agree, Dr. Goldman says that’s not his experience.

 

MDND: Are partial removals the answer for mesh removal?

 

Dr. Howard Goldman: “We do removals specific to the area bothering the patient. Whether the mesh is extruded or exposed and is causing pain we remove what’s bothering her and we only try if it’s causing problem.

 

“As far as a total removal, I’ve seen patients ended up with major vascular or bowel issues and severe complications. If they have vaginal symptoms, we remove that portion and do not dig into their thigh. We do not want to make them worse.”

 

MDND: Do you not believe in the systemic response to mesh?

 

Dr. Goldman: “Mostly what we see are not systemic but localized symptoms. We have had a systemic response and we did go after more of it only in a specific situation. But if there is pain in an area or the mesh has eroded, we take care of that and they feel fine.”

 

MDND: Women I’m hearing from are are devastated and debilitated with pain all over. Some go to see Dr. Shlomo Raz at UCLA who is seeing patients all over the world for mesh removals.

 

Dr. Goldman: “You may be seeing the tip of the iceberg, the ones who are devastated and debilitated. In our paper which appears next month in the Journal of Urology, we looked at life after 20 odd vaginal mesh kits, and the vast majority had localized treatment and after three months and six months they did well. I’m well aware of Dr. Shlomo Raz and his thoughts and I’m well aware he is a great surgeon. I’m also aware that he’s a most vocal proponent of not using mesh. He was the most vocal proponent of using mesh.

 

“But we’re seeing a lot of women who have had more damage from the removal. People don’t realize the physicians have to have a lot of experience in this area.

 

MDND? What should you ask?

 

Dr. Goldman: How many have you done and completely taken out?

 

MDND: How many total removals do you do of the people who come in with complications?

 

Dr. Goldman: “We don’t have data but it’s not the majority, hardly any.”

 

MDND: Dr Donald Ostergard says mesh is not inert. See background story here. Do you agree?

 

Dr. Goldman: “It’s the same stuff that is used in vascular surgery; the same suture material. I can tell you among the slings, the vast majority are doing fine.”

 

MDND: How about the more mesh the more mess?

 

Dr. Goldman: “Were seeing a lot of technical issues – some surgeons without good outcomes.

 

“There is a paper from a few years ago – Ridgeway, B. is the first author, and in the new one the first author is Firoozi, F. Find it in PubMed to get the Abstract.

 

“The vast majority with localized treatment at the three-month and six-month follow-up did well. I’ve seen your site and I’d like to think you are seeing the tip of the iceberg, not to discount that some women are in really bad shape with serious problems.”

 

MDND: Any idea of the complication rate?

 

Dr. Goldman: “We know from a number of studies the pain, erosion and extrusion rates when compared to no mesh. We do need more data.” #