Posts Tagged ‘FDA Warnings’

So Many Bad Drugs and Medical Devices are Affecting Women

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

It is amazing to me how many dangerous drugs and medical devices are having an affect on women. The vaginal mesh Helpline hears from women thru-out the country regarding their horiffic ecperiences with these mesh devices. Yet, there are so many other drugs and medical devices that are hurting women. The Mirena birth control device, Yaz, Yasmin, Ocella, The DePuy Hip Replacement, metal on metal hip replacements, Zimmer Duram Cup, Breast Implants, Cytotec, Topamax and others,

Mirena Birth Contol device

The Mirena Birth control device has caused amongst other side effects: Miscarriage, Risk Of Infertility, Intrauterine Pregnancy, Streptococcal Sepsis, Pelvic Inflammatory Disease Cervix, Severe Pain, Contraceptive Perforation and other side effects.

Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of the Mirena device, including perforation of or imbedment in the uterus.

Bayer actually marketed Mirena as a way  women could simplify their lifestyle. One of the ways it did so was through "Mirena Parties." Working with the social networking site Mom Central, Bayer created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. Bayer was eventually warned against this. The stories have heard and read regarding this divice are horrific.

WARNINGS AND PRECAUTIONS
Ectopic Pregnancy
Evaluate women who become pregnant while using Mirena for ectopic pregnancy. Up to half of pregnancies that occur with Mirena in place are ectopic. The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was approximately 0.1% per year.
"Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility."

Other Adverse Effects from the use of Mirena:
Sepsis, ovarian cyst formation, breast cancer, damage to conceived children, PID, embedment, amenorrhea, perforation of uterine wall or cervix may occur during insertion

Cytotec (Misoprostol)

It is estimated that in about 200,000 births in one year, Cytotec was used to stimulate delivery. This is where most of the problems with this drug, including birth defects have incurred.  The purpose of the drug was for the prevention of ulcers, but it has also been used in abortions. Brain damage to infants is of particular concern.

Yaz, yasmin Birth Control Pills

The review was prompted by two new studies recently published in the British Medical Journal, which concluded that women ages 15-44 taking birth control pills containing the synthetic progestin, drospirenone, are more likely to develop blood clots deep in the veins of the leg (venous thromboembolism), than women using birth control pills containing the common progestin levonorgestrel. The studies reported that the risk of developing blood clots for women taking the drospirenone-containing pills may be two to three times greater than those who take other pills. Yaz is one of these drugs.

Potential Yasmin and Yaz side effects may cause:

  •     Heart Attacks
  •     Strokes
  •     Cardiac Arrhythmias
  •     Blood Clots
  •     Deep Vein Thrombosis (DVT)
  •     Liver damage
  •     Anaphylactic Shock
  •     Pulmonary Embolism (PE)
  •     cervical cancer
  •     severe migraines
  •     Hair loss
  •     Gallbladder Disease
  •     Death

List of Drugs similiar to Yaz and Yasmine

Approved Oral Contraceptives containing Drospirenone

    Drospirenone and ethinyl estradiol  Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Ocella  Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Safyral  Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
    Syeda  Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Yasmin  Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Zarah  Drospirenone 3 mg and ethinyl estradiol 0.03 mg 
    Beyaz  Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
    Drospirenone and ethinyl estradiol  Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Gianvi  Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Loryna  Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Yaz  Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Topamax

Topiramate, the generic form of Johnson & Johnson’s anti-seizure drug, Topamax, is under fire from the Food & Drug Administration for its birth defect risks, Reuters reports. The medication is prescribed to patients suffering from epilepsy, and more popularly, to consumers with chronic migraine headaches. Topiramate has recently been combined with other drugs to battle obesity and bipolar disorder. More than 4.7 million prescriptions for Topamax were filled in the United States from 2007 to 2010, bringing in approximately $600 million worldwide last year.

In March 2011, the FDA issued a warning that Topamax side effects may increase the risk of oral cleft birth defects, such as cleft lip and cleft palate, among babies born to mothers who took the drug during the first trimester of pregnancy. As a result of inadequate warnings previously provided, many women were not aware they may be exposing their baby to a potential risk of Topamax birth defect.

If one looks att all the current medical devices and drugs with complications the effects on women are staggering:?  A new report says women are most likely to be injured.

 

FOSAMX EFFECTS WOMEN

 

The .Long-Term  use of Fosamax  has been shown to more then double the Risk of Femur Fractures Among Older Women.

An article in an issue of the Journal of the American Medical Association reports that long-term use of Fosamax and other bisphosphonate drugs by older women more than doubles their chance of suffering femur fractures.  This side effect is particularly disturbing in light of the fact that Fosamax and similar drugs are prescribed to strengthen the bones of women with osteoporosis.

The article summarizes a study of Canadian women aged 68 years and older who had taken oral bisphosphonates like Fosamax for five years or more.  The study found that women who had taken Fosamax and related drugs for five years or longer were 2.74 times more likely to suffer a femur fracture than women who had taken the drug for only 100 days or less.  In fact, the study concluded that more than half of the femur fractures among women who had taken bisphosphonates for five years or more were attributable to their use of bisphosphonates.

A number of Fosamax lawsuits seeking financial compensation have already been filed against Merck & Co. for injuries caused as a result of serious

TRANSVAGINAL MESH AND RELATED MESH PRODUCTS

Manufacturers of Mesh Products Include:

Johnson & Johnson

    Ethicon TVT
    Gynecare TVT
    Gynemesh PS
    Prolene Polypropylene Mesh Patch
    Secur

Bard

    Avaulta Plus BioSynthetic Support System
    Avaulta Solo Synthetic Support System
    Faslata Allograft
    Pelvicol Tissue
    PelviSoft Biomesh
    Pelvitex Polypropylene Mesh

American Medical Systems or AMS
SPARC
Boston Scientific

    Advantage Sling System
    Obtryx Curved Single
    Obtryx Mesh Sling
    Prefyx Mid U Mesh Sling System
    Prefyx PPS System

Vaginal mesh implants have been used to correct uterine prolapse and incontinence but the complications are effecting women thru-out the United States, Canada and the U.K.

complications include:

  •         Erosion of vaginal tissue can result from a vaginal mesh
  •         Hardening of the vaginal mesh
  •         Infection is a serious vaginal  mesh-patch complication
  •         Severe Pain and discomfort
  •         Perforations of the bowel, bladder or blood vessels
  •         Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
  •         Urinary problems and more severe incontinence
  •         painful sexual intercourse
  •         Vaginal mesh erosion
  •         Vaginal scarring

The transvaginal mesh Continues to effect women and alter the lives of Women and

Recent warnings have linked various birth control drugs and devices to serious injuries and even death.

 

Metal On Metal Hip Replacements like the DePuy and Zimmer

Women are reporting more problems, and a higher failure rate, with the DePuy ASR XL Acetabular hip replacement system than men. It turns out they're also more prone to some of the serious side effects of the poorly-designed implant, including metallosis.

Statistics show individuals with a small stature, such as women may be more susceptible to failure of DePuy ASR hip implants. .

Breast Implants

Breast Implant Lymphoma

In January 2011, The U.S. Food & Drug Administration (FDA) advised that women who had received breast implants should notify their doctors of any changes in their breasts because of a possible association with a rare type of lymphoma. In breast implant patients, ALCL has occurred in the scar capsule adjacent to the implant.

Symptoms of breast implant lymphoma include:

  • Pain
  • Lumps
  • Swelling
  • Asymmetry that developed after their initial surgical sites were fully healed

Historically, women are more often exposed to dangerous medical products and medical negligence than men. Some medical malpractice claims, for instance, are unique to women—like obstetrical malpractice and sexual assault by health care providers. In addition, women suffer harm from gender-specific products such as breast implants, birth control pills, osteoporosis medications and birth control devices like IUDs.

In the age of prescription drugs and antidepressants, where drugs are administered over-the-counter without any major restrictions, more people are dying each year from medications than from traffic accidents. A recent L.A. Times article looked at the impact prescription drugs have upon American society, and their dangers if used in certain combinations.

In 2009, prescription drugs factored in the deaths of over 37,000 people. Less people died in motor vehicle accidents that year, which was a  new phenomenon, according to the U.S. Centers for Disease Control and Prevention.

The vaginal mesh helpline hopes that the new bill coming before congress will protect women from manufacturers whose products slip thru and eventually are either recalled or end up with warnings. These drugs and medical devices are hurting women.

 

 

 

Prolene mesh Trans vaginal mesh,Surgical Mesh and Pelvic organ Prolapse

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Information

Prolene mesh and your prolapse surgery – erosions, sex, and the latest data. The transvaginal mesh is made of a prolene substance which is creating problems in woman with the various transvaginal mesh patch implants. The following information on the prolene mesh substance is of interest and being passed along for our readers. In doing so we hope to offer informations,support and help to women who have been suffering form these vaginal mesh products. Many of our callers and followers do not really understand what these mesh products are. They merely followed the advise of their physicians to relieve discomfort and improve theor quality of life. Hope has  turned to pain and women worldwide have stories to tell about their transvaginal Mesh.

The following is by Lauri Romanzi on the prolene mesh

Prolene Mesh and Pelvic Organ Prolapse
Cystocele, rectocele, erosions, sex, mesh shrinkage, folding and thickening,transvaginal mesh

 

 

Prolene mesh is the product name for a permanent plastic mesh with many implantation applications in reconstructive surgery. Prolene mesh is used to fix large and small abdominal hernias, inguinal hernias, hernias of the diaphragm; it’s used to resuspend kidneys (nephropexy) rectums (rectopexy), uteri (aka uterus’ plural) (sacrohysteropexy), prolapsed vaginas after hysterectomy (sacrocolpopexy), chin augmentations (mentoplasty), chest wall repair in certain thoracic surgeries, (abdominal hernias (inguinal, umbilcal, ventral) and both male and female urethral sling operations for stress urinary incontinence, to name a few.

Over the last 8-10 years, the use of prolene mesh for vaginal prolapse surgery has expanded to include cystocele and rectoceele repair, In an effort to standardize application and, arguably, make it easier for gynecology, urogynecology and urology surgeons to use the mesh, and, definitely, to market the new pelvic organ prolapse mesh kits effectively, Prolene mesh companies have tweaked mesh pore size (degree of laciness), thickness, and density; they’ve mixed it with other graft materials, impregnated it with various materials, each in an effort to reduce horrific complications and claim clinical superiority. The industry cannot advertise or market superiority without data, so they sponsor scientific clinical trials hoping for favorable data that will legally permit them to claim product  superiority in marketing activities, via studies paid for in part or in full by the companies manfacturing the mesh, often but not always recruiting surgeons who work as paid advisors and consultants, much the same way pharmaceutical companies use paid advisors to participate in clinical drug trials. I know, I’ve been, at various points in my career, one of those advisor/consultants. It is a very fine ethical tightrope clinicians walk when participating at that level. The perks are large. The rewards many. It’s an elite group of clinical industry insiders that trumpet the merits of these meshes. Those surgeons publishing outside of the advisory board arena compete for journal space along side industry funded trials.

A few times a year, I and a few colleagues comb the literature for the Journal of Sexual Medicine, fashioning reviews of research with a sexual function implication. This month, I found three that “turn me on” – 2 of which focus on Prolene mesh for vaginal implantation in pelvic organ prolapse surgery for cystoceles (dropped bladders) and rectoceles (back wall vaginal hernias).

Here are the two trials on 2 different Prolene mesh kits: AMS Perigee and Gynecare Prolift.

The first study, using Prolift, found that young sexually active women were more likely to suffer vaginal erosion of mesh, literally mesh showing where the vaginal skin over it has eroded away. A bit of a problem, if your young, like sex, have prolapse, and use Prolene mesh, at least with this particular kit, to have it fixed. Prolene mesh in the vagina creates a mechanical risk of sexual dysfunction; your sex life could, quite literally, hit the skids. Forget carpet burns, we’re talking penis-meets-sand paper. Woops.

The second study, using a different brand of Prolene mesh vaginal prolapse kit for dropped bladder (cystocele) repair called Perigee, claims a close-to-zero mesh erosion rate, each erosion “minimal and easily remedied” with a bit of tinkering in the office. The investigators report some interesting ongoing changes in the sonographic appearance of the mesh once implanted in the vagina. In this study, Prolene mesh demonstrated folding in a few, and continued to shrink or shorten and thicken more and more at each of three sonograms done in the first year after implantation. Makes you wonder how it’s behaving after, say, 5  or 10 years.

I’ve said before and I’ll say again here, Prolene mesh ribbons for uterine suspension, vaginal cuff suspension after hysterectomy and female urethral sling operations for urinary incontinence have been around a long time and really do seem, in my experience and in my opinion, to work very well with low rates of minimally bothersome, easy to fix complications. BUT I’ve seen nightmares with Prolene mesh kits used for cystocele and rectocele repair – full recurrence of the prolapse, sometimes worse that before surgery, along with horrific, painful, bleeding mesh  vaginal or bladder erosions, kinking of ureters (the tubes that drain urine from your kidney to your bladder) glued to the mesh requiring ureteral re-implantation into a diffierent part of the bladder (this is big surgery, not a quickie), in addition to mesh bundles eroding into the vagina creating bleeding vaginal wounds that make sex impossible. Explanting (removing it in full) Prolene mesh from the anterior and posterior walls of the vagina is no easy task.

The Vaginal mesh helpline listens to women daily with horror stories of the complications of the mesh. Tell us your stories.We want to hear from you iin: Auburn AL; Birmingham AL; Dothan AL; Gadsden AL; Huntsville AL; Mobile AL; Montgomery AL; Muscle Shoals AL; Tuscaloosa AL; Anchorage AK; Fairbanks AK; Juneau AK; Flagstaff AZ; Sedona AZ; Mohave County AZ; Phoenix AZ; Prescott AZ; Show Low AZ; Sierra Vista AZ; Tucson AZ; Yuma AZ; Fayetteville AR; Fort Smith AR; Jonesboro AR; Little Rock AR; Bakersfield CA; Chico CA; Fresno CA; Humboldt County CA; Inland Empire CA; Long Beach CA; Los Angeles CA; Mendocino (new) CA; Merced CA; Modesto CA; Monterey CA; O.C. CA; Oakland CA; Palm Springs CA; Palmdale CA; Redding CA; Sacramento CA; San Diego CA; San Fernando Valley CA; San Francisco CA; San Gabriel Valley CA; San Jose CA; San Luis Obispo CA; San Mateo CA; Santa Barbara CA; Santa Cruz CA; Santa Maria CA; Siskiyou CA; Stockton CA; Susanville CA; Ventura CA; Visalia CA; Boulder CO; CO Springs CO; Denver CO; Fort Collins CO; Pueblo CO; Rockies CO; Western Slope CO; Eastern CT CT; Hartford CT; New Haven CT; Northwest CT CT; Wilmington DE; Dover DE; Newark DE; Pike Creek DE; Bear DE; Washington D.C. District of Columbia; Daytona FL; Fort Myers FL; Ft Lauderdale FL; Gainesville FL; Jacksonville FL; Keys FL; Lakeland FL; Miami FL; Ocala FL; Orlando FL; Panama City FL; Pensacola FL; Sarasota FL; Space Coast FL; St. Augustine FL; Tallahassee FL; Tampa FL; Treasure Coast FL; West Palm Beach FL; Albany GA; Athens GA; Atlanta GA; Augusta GA; Brunswick GA; Columbus GA; Macon GA; Northwest GA GA; Savannah GA; Statesboro GA; Valdosta GA; Big Island HI; Honolulu HI; Kauai HI; Maui HI; Boise ID; East ID ID; Lewiston ID; Twin Falls ID; Bloomington IL; Carbondale IL; Chambana IL; Chicago IL; Decatur IL; La Salle County IL; Mattoon IL; Peoria IL; Rockford IL; Springfield IL; Western IL IL; Bloomington IN; Evansville IN; Ft Wayne IN; INpolis IN; Kokomo IN; Lafayette IN; Muncie IN; Richmond IN; South Bend IN; Terre Haute IN; Cedar Rapids IA; Des Moines IA; Dubuque IA; Fort Dodge IA; IA City IA; Mason City IA; Ottumwa IA; Quad Cities IA; Sioux City IA; Waterloo IA; Lawrence KS; Manhattan KS; Topeka KS; Wichita KS; Bowling Green KY; Eastern KY KY; Lexington KY; Louisville KY; Owensboro KY; Western KY KY; Baton Rouge LA; Lafayette LA; Lake Charles LA; Monroe LA; New Orleans LA; Shreveport LA; Portland ME; Lewiston ME; Bangor ME; West Scarborough ME; Annapolis MD; Baltimore MD; Cumberland Valley MD; Eastern Shore MD; Frederick MD; Western MD MD; Boston Massachusetts; Cape Cod Massachusetts; South Coast Massachusetts; Springfield Massachusetts; Worcester Massachusetts; Ann Arbor MI; Battle Creek MI; Central MI MI; Detroit MI; Flint MI; Grand Rapids MI; Holland MI; Jackson MI; Kalamazoo MI; Lansing MI; Monroe MI; Muskegon MI; Northern MI MI; Port Huron MI; Saginaw MI; Southwest MI MI; Upper Peninsula MI; Duluth MN; Mankato MN; Minneapolis MN; St Paul MN; Rochester MN; St. Cloud MN; Biloxi MS; Hattiesburg MS; Jackson MS; Meridian MS; Natchez MS; North MS MS; Columbia/Jeff City MO; Joplin MO; Kansas City MO; Kirksville MO; Lake of the Ozarks MO; Southeast MO MO; Springfield MO; St. Joseph MO; St. Louis MO; Billings MT; Missoula MT; Great Falls MT; Bozeman MT; Butte MT; Grand Island NE; Lincoln NE; North Platte NE; Omaha NE; Scottsbluff NE; Las Vegas NV; Reno NV; Manchester NH; Nashua NH; East Concord NH; Concord NH; Derry Village NH; Central Jersey NJ; Jersey Shore NJ; North Jersey NJ; South Jersey NJ; Albuquerque New Mexico; Santa Fe New Mexico; Albany NY; Binghamton NY; Buffalo NY; Catskills NY; Chautauqua NY; Elmira NY; Finger Lakes NY; Glens Falls NY; Hudson Valley NY; Ithaca NY; Long Island NY; New York City NY; Oneonta NY; Plattsburgh NY; Potsdam NY; Rochester NY; Syracuse NY; Twin Tiers NY; Utica NY; Watertown NY; Westchester NY; Asheville NC; Boone NC; Charlotte NC; Eastern NC; Fayetteville NC; Greensboro NC; Hickory NC; Outer Banks NC; Raleigh NC; Wilmington NC; Winston Salem NC; Fargo ND; Akron OH; Canton OH; Ashtabula OH; Athens OH; Chillicothe OH; Cincinnati OH; Cleveland OH; Columbus OH; Dayton OH; Huntington/Ashland OH; Lima/Findlay OH; Mansfield OH; Sandusky OH; Toledo OH; Tuscarawas County OH; Youngstown OH; Zanesville/Cambridge OH; Lawton OK; OK City OK; Stillwater OK; Tulsa OK; Bend OR; Corvallis OR; East OR OR; Eugene OR; Medford OR; OR Coast OR; Portland OR; Roseburg OR; Salem OR; Allentown PA; Altoona PA; Cumberland Valley PA; Erie PA; Harrisburg PA; Lancaster PA; Meadville PA; Philadelphia PA; Pittsburgh PA; Poconos PA; Reading PA; Scranton PA; State College PA; Williamsport PA; York PA; Providence RI; Warwick RI; Cranston RI; Pawtucket RI; East Providence RI; Woonsocket RI; Charleston SC; Columbia SC; Florence SC; Greenville SC; Hilton Head SC; Myrtle Beach SC; Sioux Falls SD; Rapid City SD; Aberdeen SD; Chattanooga TN; Knoxville TN; Memphis TN; Nashville TN; Tri-cities TN; Abilene TX; Amarillo TX; Austin TX; Beaumont TX; Brownsville TX; College Station TX; Corpus Christi TX; Dallas TX; Denton TX; El Paso TX; Fort Worth TX; Galveston TX; Houston TX; Huntsville TX; Killeen TX; Laredo TX; Lubbock TX; Mcallen TX; Odessa TX; San Antonio TX; San Marcos TX; Texarkana TX; Texoma TX; Tyler TX; Victoria TX; Waco TX; Wichita Falls TX; Logan UT; Ogden UT; Provo UT; Salt Lake City UT; St. George UT; Burlington VT; Essex Junction VT; Bennington VT; Charlottesville VA; Chesapeake VA; Danville VA; Fredericksburg VA; Hampton VA; Harrisonburg VA; Lynchburg VA; New River Valley VA; Newport News VA; Norfolk VA; Portsmouth VA; Richmond VA; Roanoke VA; SouthWV VA; Suffolk VA; VA Beach VA; Bellingham WA; Everett WA; Moses Lake WA; Olympia WA; Pullman WA; Seattle WA; Spokane WA; Tacoma WA; Tri-cities WA; Wenatchee WA; Yakima WA; Charleston WV; Huntington WV; Martinsburg WV; Morgantown WV; Parkersburg WV; Southern WV WV; Wheeling WV; Appleton WI; Eau Claire WI; Green Bay WI; Janesville WI; La Crosse WI; Madison WI; Milwaukee WI; Racine WI; Sheboygan WI; Wausau WI; Cheyenne WY; Casper WY; Laramie WY; Gillette WY;

We have attorneys in: Alabama Al Alaska Arizona Az Scottsdale Arkansas California Ca Colorado Co Connecticut Conn Delaware De D.C. Florida Fl Georgia Ga Hawaii Idaho Illinois Ill Indiana Iowa Kansas Kentucky Louisiana La Maine Maryland Massachusetts Mass Michigan Mi Minnesota Minn Mississippi Ms Missouri Mo Montana Nebraska Nevada Nv New Hampshire New Jersey N.J. New Mexico. N.M New York N.Y Brooklyn Queens Staten Island Long Island Westchester North Carolina North Dakota N.C Ohio Oh Oklahoma Ok Oregon Pennsylvania Pa Rhode Island RI South Carolina S.C South Dakota S.D Tennessee Tenn Texas TX Utah Ut Vermont Virginia Washington Wa West Virginia Wisconsin Wyoming.