Public Citizen blasts FDA for weak regulation of implanted surgical mesh.

FDA Wants High-Risk Label forTransvaginal Mesh

Published: Apr 29, 2014

By Charles Bankhead, Staff Writer, MedPage Today, 

Public Health & Policy

FiDA highlight

WASHINGTON -- The FDA has proposed reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as a "high-risk device," a designation that mandates an FDA review of safety and effectiveness prior to considering approval.

The agency also wants to reclassify certain instruments used to perform POP repair as "intermediate-risk devices," as opposed to the current low-risk designation.

"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, MD, of the FDA's Center for Devices and Radiological Health, said in a statement. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."

The proposal does not affect surgical mesh used to treat stress urinary incontinence (SUI), abdominal POP repair, hernia repair, and other nonurogynecologic indications. The proposal is subject to a 90-day public-comment period prior to a final decision.

The proposed reclassification follows other FDA actions and statements related to transvaginal POP repair materials going back 6 years:

         October 2008 -- Released a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh for POP and SUI

         July 2011 -- Released an updated safety communication about serious complications associated with transvaginal POP repair with surgical mesh

         July 2011 -- Released a review of urogynecologic surgical mesh adverse events and scientific literature, identifying serious safety and effectiveness concerns

         September 2011 -- FDA's Obstetrics and Gynecology Devices Panel recommended reclassification of surgical mesh for transvaginal POP repair from class II to class III and require premarket approval

         January 2012 -- FDA ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns about surgical mesh used for transvaginal POP repair

Some materials to repair POP come as kits that include the mesh and instruments used to place, attach, and secure the mesh. Instruments also are sold separately from the mesh, and the FDA proposal to reclassify instruments pertains to the instruments that are not included in kits.

The FDA action represents a case of "too little, too late," according to Michael Carome, director of Public Citizen's Health Research Group, a Washington-based public health advocacy group. Public Citizen has petitioned the FDA to recall all surgical mesh products from the market.

"Today's action comes nearly 3 years after our petition and after an FDA advisory committee recommended such action," Carome said in a statement. "Moreover, the proposed timeline for full implementation of the FDA's order, if finalized, will take several more years.

"As a result of the FDA's reckless delays and inadequate action regarding surgical mesh for transvaginal POP repair, thousands of women will continue to be unnecessarily exposed to a wide array of serious risks, many of which can permanently alter women's quality of life."

Bayer Essure: In German or English - Dangerous Birth Control

Tuesday, April 29, 2014

Bayer Stockholder Annual Meeting Speech- English Version

FiDA highlight

Good morning, I’ve prepared something I’d like to read to you. I’ll first speak in English, and then I’m prepared to give the same statement in German if necessary. I have also prepared some questions for the members of the Board.

A few years ago, I had a Bayer device implanted inside me. I chose this device, a birth control device, because it was approved by the United States Food and Drug Administration. This was device was also advertised as safe and effective. The biggest mistake of my life was choosing this device. It would change me, leaving me with permanent reminders of the day I almost died. The physical and emotional scars will never go away.

My name is Michelle Garcia and I live in Miami, Florida. I am an Essure victim, an Essure survivor and a voice to thousands. I stand before you with a simple, yet powerful message. Essure is dangerous and Essure does not belong on the market.

Essure is a form of birth control which is intended to be the non-surgical alternative to a tubal ligation. In April of 2013, Bayer announced the acquisition of a company called Conceptus. During the time they were in existence, Conceptus was never profitable. When Bayer acquired Conceptus, you also acquired Essure. Seven studies following less than six hundred women with Essure were published. The data from these studies was presented when Essure was approved for use in the United States. The same data is also used to support claims the device is safe and effective.

My story goes like this . . . A broken Essure coil pierced my fallopian tube, resulting in internal bleeding and hemorrhaging. Fortunately, while in the emergency room, the bleeding stopped but not before I lost a significant amount of blood and coming close to needing a blood transfusion. I could be dead; I should be dead. As terrified as I was and as frightening as my experience is, there are countless women with stories far worse than mine. For every story we do know, there are thousands more still unreported.

In 2011, a mom named Angie Firmalino, started a group called Essure Problems to warn her friends about the effects this device had on her body. I found the group in May of 2012 when there were only 30 members. Today, worldwide, we are more than 7,000 women strong, 10 times more than the size of your studies.

Gabriela Avina is a health care professional with a Master’s degree in Women’s Health Nursing. She was involved in the clinical trials professionally and became a clinical trial participant in October of 2000. In 2002, she presented to the United States Food and Drug Administration as a clinical trial patient. Gabriela went on to become a spokesperson for Essure, and she toured the United States promoting Essure. Little did she know, the device was slowly destroying her health.

Earlier this year, Gabriella made a second presentation to the United States Food and Drug Administration. During this presentation, she stated that she was wrong when she supported this device 12 years ago. In her own words, she said, “Lives of women have been changed by a device that was not adequately monitored during clinical trials, by physicians who were not adequately trained and by a company that has not adequately listened to their patients.”

So how safe and effective is your device? 3% of the ladies in our group is either currently pregnant or has been pregnant. 2% of the pregnancies ended in death of the child with 55% of our ladies suffering miscarriages. That is a big difference from your published success rate of 99%. The March of Dimes reports the expected rate for miscarriages is ten to fifteen percent.

We prepared a survey so we could collect more specific information from the ladies in our group. The responses support the urgent need to have this device immediately removed from the market. Almost 40% reported issues related to Essure almost immediately after placement with 32% reporting that their coils are no longer properly placed. After successful placement and confirmation of occlusion, the coils may move.

Ectopic pregnancy, which has an expected occurrence rate of 2%, occurred in 14% of our pregnancies. 48% indicated they have experienced three or more miscarriages. For a device that’s effective, 15% of the respondents reported they did not achieve successful tubal occlusion. That 85% failure rate is a significant difference from the success rate reported during the clinical trials.

Almost 1,000 women, over 16% of our membership, women as young as 22 years old, have had major surgeries, usually a hysterectomy to remove the coils. In many instances, one surgery isn’t enough to repair all the damage. Many have endured multiple surgical procedures costing significant amounts of money. These multiple surgeries are usually to find errant coils which have ended up outside the fallopian tube. Essure may be the non-surgical alternative to a tubal ligation, but it is NOT going to keep someone out of the operating room.

The “lucky” ladies have coils expel into their uterus. For some women, doctors have retrieved coils from the vicinity of their liver, kidney, chest cavity, abdominal cavity and the lining of their stomach. One woman had an Essure coil migrate into her colon. She was required to have a colon resection due to the buildup of scar tissue. Her intestines also fused to her rectum. Despite this, Essure continues to be labeled and marketed as a form of birth control that is SAFE.

For the 84% of our group who have not been able to get the coils removed due to a lack of financial resources or the inability to find a surgeon willing to remove them, they suffer from the same debilitating side effects which led the other ladies in our group to the operating room.

Many of these women can attribute their issues to an allergic reaction to nickel, and an Essure coil is over 50% nickel. Nickel is a common allergen and a contraindication was included when the device was first marketed. The contraindication was removed from the label in 2011. The CEO of Conceptus explained the purpose of the new label was to further strengthen our competitive advantage and leadership in the permanent birth control market. In the same press release, he states that Conceptus will be aggressively marketing this change to the members of the OB/GYN community who won’t use our product “primarily because of potential nickel allergy in patients.” The motivation for this change was not based on patient safety but on the manufacturer’s financial interest. They did such a great job with their aggressive marketing that 82% of the respondents to our survey were not asked about any metal sensitivities. And the change in label led some doctors to believe that nickel had been completely removed from the product.

Women suffering from an allergic reaction live with constant pain, irritation and inflammation.

Women without a nickel allergy are also suffering with similar intense side effects which rob us of our health and a quality of life. We suffer with severe pelvic plain, headaches, joint pain and deterioration, chronic inflammation, extreme fatigue, severe bloating, skin conditions, irregular bleeding and many other side efforts. The side effects of Essure affect everyone in a family, not just the patient. Children grow up with a mom who is not healthy — who can’t lift and hug her child. Couples are robbed of their ability to have an intimate relationship because the act of making love is far too painful. Women post messages in our group contemplating suicide because of the pain caused by Essure. They are just so sick that being dead just seems like a better alternative. All of this for birth control; just birth control.

I leave you with two final stories. The first is a baby named Julius. He was conceived because, as with so many, Essure failed. Julius’ mom went into premature labor when an Essure coil perforated her amniotic sack causing her water to break. Julius was born alive, and his under-developed lungs couldn’t sustain him. Julius died on the day he was born, an innocent victim of a device you continue to say is safe and effective.

We learned about the women in the last story when an adverse event report was filed with the "United States Food and Drug Administration". While we don’t know her name, we know she was someone’s wife, mother and daughter. She had Essure and went to the emergency room complaining of abdominal pain. An exam found that her reproductive system, specifically her cervix, fallopian tubes and uterus were necrotic. In layman’s term, her organs were dead. She went into renal failure and did not recover. Her cause of death is listed as necrosis and toxic shock syndrome. The question of what caused her organs to die resulting in her death can’t be answered based on a report; however, it’s a coincidence that can’t be ignored.

Julius and the women in report number are dead. Will you still say this device is safe and effective?

On behalf of the 7,000 women who trust me to be their voice, and the women we have yet to hear from, we ask you, pull Essure from the market. I thank you for the opportunity to speak before you. Please do the right thing. Remove Essure from the market.

The Mom vs. Melinda Gates

This blog isn't only about me or Melinda Gates, its much bigger, its about a battle against the FDA and a defective birth control device called Essure. The Gates Foundation dispenses this product as part of their global contraceptive initiaive.

Michelle  

I'm a mom from Miami, Florida. This blog tells the story how I went from victim, to advocate to activist for women's birth control and against the FDA and a dangerous birth control device called Essure.

Surgical Mesh: High-Risk Device via FDA

FDA NEWS RELEASE

FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” 

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).

Beginning in Jan. 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

In Sept. 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an Oct. 2008 FDA Public Health Notification.

Surgical mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of this proposed order.

The FDA will take comments on the proposed order for 90 days.

For more information:

•               FDA Medical Devices

•               FDA: Proposed Order - “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation” 

•               FDA: Proposed Order - “Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”

•               FDA: Urogynecologic Surgical Mesh Implants

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

# # #

Read our Blog: FDA Voice

Visit the FDA on Facebook  , Flickr  , YouTube  , and Twitter

RSS Feed for FDA News Releases

For Immediate Release: April 29, 2014  
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA, DICE@fda.hhs.gov

Page Last Updated: 04/29/2014 
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Erin Brockovich, Bayer and Essure horror stories

Bayer contraceptives : Sterilization with sideeffects

By Marc Pitzke, Spiegel online/New York

(AFP)  Consumer activist Erin Brockovich: "We seek dialogue with Bayer "

FiDA highlight/Google translation to English from German

 The legendary U.S. consumer activist Erin Brockovich has a new goal - the German Bayer AG. It's about their contraception Essure . Hundreds of women complain of some horrible side effects.

The gynecologist had promised: Everything would proceed entirely " pure and simple ". Two short, outpatient routine interventions , no anesthesia, done. So uncomplicated, the procedure let themselves almost at lunchtime do.

But after the first appointment, Michelle Garcia doubled in "excruciating pain " . After the second, it only got worse : Suddenly the otherwise dynamic woman was constantly tired , then the pain came back , and eventually she began to bleed uncontrollably hard.

"I almost died," the then 38 -year-old recalls. Fast: "I was lucky. "

What Garcia 2011 almost proved fatal, is in fact actually routine. The single mother from Miami did not want any more children and had therefore opted for the Essure procedure, the only permanent method of contraception without surgery. Two blocking coils are placed in the fallopian tube. " A quick, ten minute procedure in your doctor's office," says the manufacturer , Bayer HealthCare , a U.S. subsidiary of Bayer AG in New Jersey.

Been hundreds of horror stories on record

Michelle Garcia, however, is not the only one in the method went wrong. Hundreds of women have now given Essure horror stories on record, on blogs, websites, Twitter and their own Facebook group : chronic fatigue, depression, weight gain , Fibrositissyndrom , degenerative diseases , autoimmune disorders and menstrual disorders, migraine , allergic reactions, rash, dizziness, fever, unwanted pregnancies , miscarriages. Some of the coils are at least partially migrated through the body.

A petition, Essure " to stop or take this product off the market completely ," now contributes nearly 8000 signatures. The protesters also have prominent flank protection: The consumer activist Erin Brockovich - known by the eponymous film, the 2001 Oscar brought Julia Roberts - has done to their side.

"These women have no chance of recourse," Brockovich complains in an interview with SPIEGEL ONLINE . Since its legendary environmental struggle against U.S. power giant PG & E 20 years ago the infamous for their doggedness Ex - paralegal but has become more circumspect. Cooperation instead of war: "We seek dialogue with Bayer. "

But so far, let Bayer rebuffed them. Therefore Garcia and Angela Lynch travel, one of her fellow-sufferers, now to Germany to confront Supervisory Board Chairman Werner Wenning and the Chief Executive Officer Marijn Dekkers at the Bayer Annual General Meeting on Tuesday in Cologne directly. At the invitation of the activist group Coalition against Bayer Dangers Garcia wants to step up to the microphone there.

Bayer, the problem has indeed saddled probably unintentionally, as it bought up the Essure Conceptus manufacturer last year for $ 1.1 billion. "Bayer and Conceptus have the goal with innovations to promote the health of women," rejoiced Andreas Fibig, the CEO of Bayer HealthCare Pharmaceuticals, still there.

"I do not want others to have to join the same "

"Anyone who feels pain or complications, for whatever reason, our great compassion ," said Edio Zampaglione, Vice President of U.S. Medical Affairs at Bayer winds . Bayer debt wear but no: "There is no birth control method that is one hundred percent effective, and which is also clear in our leaflet. "

Derlei " adverse events," said Zampaglione continued, were also " in clinical trials " and a study by the U.S. Pharmacopeia Drug Administration (FDA?) has already been observed and recognized from the beginning. The turn keeps these side effects for infrequent: Essure is " effective as a means of permanent sterilization to 99.83 percent."

Michelle Garcia took their claims to only five months to find out that their pain decreased on Essure. It turned out, therefore, that a coil broken and had wandered in Garcia's abdomen. Both coils should be removed surgically.

Garcia started in a support group to get involved, which now has more than 7,000 members: "I do not want others must join the same." They also sent in 2013 a long letter to Bayer CEO Dekkers, investor relations chief Alexander Rosar and spokeswoman Tricia McKernan . "Women suffer unspeakable pain and serious discomfort, which they got after Essure was implanted," she wrote and warned Bayer. " You now have a nightmare " One answer they never got.

Why are they now pilgrimage to Cologne, " in the lion's den," she says. For their big entrance at Tuesday Garcia has even trained with a coach public speaking because German language was required: " The women rely on my voice. "

Bayer-Verhütungsmittel: Sterilisation mit Nebenwirkungen

Von Marc Pitzke, New York   (Original German)

Die legendäre US-Verbraucheraktivistin Erin Brockovich hat ein neues Ziel - die deutsche Bayer AG. Es geht um deren Verhütungsmittel Essure. Hunderte Frauen klagen über teils grausige Nebenwirkungen.

AFP

Verbraucheraktivistin Erin Brockovich: "Wir suchen den Dialog mit Bayer"

Der Gynäkologe hatte es versprochen: Alles würde ganz "einfach und simpel" verlaufen. Zwei kurze, ambulante Routine-Eingriffe, keine Narkose, fertig. So unkompliziert, die Prozedur lasse sich quasi in der Mittagspause erledigen.

Doch schon nach dem ersten Termin krümmte sich Michelle Garcia unter "qualvollen Schmerzen". Nach dem zweiten wurde es nur noch schlimmer: Auf einmal war die sonst so dynamische Frau dauernd todmüde, dann kamen die Schmerzen zurück, und schließlich begann sie, unkontrollierbar schwer zu bluten.

"Ich wäre fast gestorben", erinnert sich die damals 38-Jährige. Fast: "Ich hatte Glück."

Was Garcia 2011 beinahe zum Verhängnis wurde, ist in der Tat eigentlich Routine. Die alleinstehende Mutter aus Miami wollte keine Kinder mehr und hatte sich deshalb für das Essure-Verfahren entschieden, die einzig dauerhafte Methode der Empfängnisverhütung ohne Operation. Dabei werden zwei Blockade-Spulen in die Eileiter gesetzt. "Eine schnelle, zehnminütige Prozedur in Ihrer Arztpraxis", versichert der Hersteller Bayer HealthCare, eine US-Tochter der Bayer AG in New Jersey.

Hunderte Horrorstorys zu Protokoll gegeben

Michelle Garcia ist aber nicht die Einzige, bei der die Methode schiefging. Hunderte Frauen haben inzwischen Essure-Horrorstorys zu Protokoll gegeben, auf Blogs, Websites, Twitter und in einer eigenen Facebook-Gruppe: chronische Müdigkeit, Depressionen, Gewichtszunahme, Fibrositissyndrom, Degenerationskrankheiten, Autoimmun- und Menstruationsstörungen, Migräne, allergische Reaktionen, Ausschlag, Schwindelgefühle, Fieber, ungewollte Schwangerschaften, Fehlgeburten. Bei einigen seien die Spulen zumindest teilweise durch den Körper gewandert.

Eine Petition, Essure "zu stoppen oder dieses Produkt ganz vom Markt zu nehmen", trägt mittlerweile fast 8000 Unterschriften. Die Protestler haben außerdem prominenten Flankenschutz: Die Verbraucheraktivistin Erin Brockovich - bekannt durch den gleichnamigen Film, der Julia Roberts 2001 einen Oscar brachte - hat sich auf ihre Seite geschlagen.

"Diese Frauen haben keinerlei Aussichten auf Regress", klagt Brockovich im Gespräch mit SPIEGEL ONLINE. Seit ihrem legendären Umweltkampf gegen den US-Stromriesen PG&E vor 20 Jahren ist die für ihre Verbissenheit berüchtigte Ex-Anwaltsgehilfin aber bedächtiger geworden. Kooperation statt Krieg: "Wir suchen den Dialog mit Bayer."

Doch bisher ließ Bayer sie abblitzen. Deshalb reisen Garcia und Angela Lynch, eine ihrer Leidensgenossinnen, jetzt nach Deutschland, um Aufsichtsratschef Werner Wenning und den Vorstandsvorsitzenden Marijn Dekkers bei der Bayer-Hauptversammlung am Dienstag in Köln direkt zu konfrontieren. Auf Einladung der Aktivistengruppe Coordination gegen Bayer-Gefahren will Garcia dort ans Mikrofon treten.

Bayer hat sich das Problem ja auch eher ungewollt aufgehalst, als es den Essure-Hersteller Conceptus im vergangenen Jahr für 1,1 Milliarden Dollar aufkaufte. "Bayer und Conceptus haben das Ziel, mit Innovationen die Gesundheit von Frauen zu fördern", freute sich Andreas Fibig, der Vorstandschef von Bayer HealthCare Pharmaceuticals, da noch.

"Ich will nicht, dass andere das Gleiche mitmachen müssen"

"Jeder, der Schmerzen oder Komplikationen empfindet, egal aus welchem Grund, hat unser großes Mitgefühl", windet sich Edio Zampaglione, Vice President US Medical Affairs bei Bayer. Schuld trage Bayer aber keine: "Es gibt keine Verhütungsmethode, die hundertprozentig effektiv ist, und das steht auch klar auf unserem Beipackzettel."

Derlei "unerwünschte Ereignisse", so Zampaglione weiter, seien außerdem "in klinischen Tests" und einer Studie der US-Arzneibehörde FDA schon von Anfang an beobachtet und anerkannt worden. Die wiederum hält diese Nebenwirkungen für selten: Essure sei "als Mittel zur permanenten Sterilisierung zu 99,83 Prozent effektiv".

ANZEIGE

Michelle Garcia brauchte ihren Angaben zufolge allein fünf Monate, um herauszufinden, dass ihre Pein auf Essure zurückging. Es stellte sich demnach heraus, dass eine Spule zerbrochen und in Garcias Bauchraum gewandert war. Beide Spulen sollen operativ entfernt worden sein.

Garcia begann sich in einer Hilfsgruppe zu engagieren, die inzwischen mehr als 7000 Mitglieder hat: "Ich will nicht, dass andere das Gleiche mitmachen müssen." Auch schickte sie schon 2013 einen langen Brief an Bayer-Chef Dekkers, Investor-Relations-Chef Alexander Rosar und Sprecherin Tricia McKernan. "Frauen erleiden unsägliche Schmerzen und ernsthafte Beschwerden, die sie bekamen, nachdem Essure implantiert wurde", schrieb sie und warnte Bayer: "Sie besitzen jetzt einen Alptraum." Eine Antwort bekam sie nie.

Weshalb sie nun nach Köln pilgert, "in die Höhle des Löwen", wie sie sagt. Für ihren großen Aufritt am Dienstag hat Garcia sogar mit einem Coach öffentliches Reden trainiert: "Die Frauen verlassen sich auf meine Stimme."

SCANDAL: Surgical mesh in Scotland

            News

            Scottish News

            Mesh surgery scandal

Labourhealth spokesman Andy Burnham accuses the Government of failing women living inagony because of mesh implants

         Apr 27, 2014 14:18

         By Marion Scott

THE health spokesman says the Government must act now to end the devastating injuries and enduring agony suffered by hundreds of Scots women.

Mesh victim Caroline Tait outside Scottish Parliament

LABOUR'S health spokesman Andy Burnham has accused the Government of failing women living in agony because of mesh implants.

He criticised SNP health secretary Alex Neil over his refusal to suspend the use of the controversial treatments.

It follows a Sunday Mail campaign which has highlighted devastating injuries and enduring agony suffered by hundreds of Scots women.

Burnham said: “The evidence from health boards is shocking and clearly shows thousands of women have been affected by these products which can have life-altering consequences.

“Some of the cases revealed by the Sunday Mail are heart-breaking when what should be a simple procedure has left women disabled.

“I’m surprised by the lack of action or leadership being shown by the Scottish Government.”

Burnham backs Scotland’s shadow health secretary Neil Findlay who has called on Alex Neil to suspend the use of mesh until an inquiry can properly assess the scale of the scandal.

Pressure on Neil is growing after a US court decision found one of the most widely used vaginal mesh implants, produced by Johnson & Johnson subsidiary Ethicon, was defective.  (Batiste v. McNabb/J&J Ethicon in Dallas, TX)

Findlay said: “After the US ruling, Alex Neil should have suspended the use of mesh in Scotland and instructed health boards to 
contact every woman given this implant to check whether they are experiencing any problems.”

Hundreds of thousands of women around the world have reported injuries inflicted by mesh eroding in their bodies.

Many have faced a series of ops as surgeons struggle in vain to remove the mesh used to treat prolapse and bowel conditions.

American courts have already awarded damages of millions of pounds to the victims.

More than 400 cases are lodged in Scotland. The Scottish Government said: “We continue to work with professional organisations to improve 
reporting and monitoring of procedures using mesh.”

Johnson & Johnson are considering appealing last month’s judgment that their TVT-O device was defective.

Spokeswoman Lucinda Macari said: “The verdict is disappointing and we believe we have strong grounds for an appeal.”

Leslie McGlinchey, 33, of Drumchapel, Glasgow, who was forced to use a wheelchair after a mesh implant three years ago, said: “Politicians continue to ignore this scandal at their peril.

“When things go wrong, the damage is so devastating, it affects whole families.

“We’re calling on everyone to sign our petition and get this stuff out of our hospitals.”

The Hear Our Voice petition closes on Wednesday.

www.scottish.parliament.uk/gettinginvolved/petitions/scottishmeshsurvivors