Chronological History of Mesh
First urogynaecological meshes approved for supply in the USA
First urogynaecological meshes approved for supply in Australia
TGA receives the first adverse event report relating to a urogynaecological mesh
The US-FDA issues a Safety Communication recommending that surgeons should undertake specialised further training and should notify patients that mesh is permanent, complications can occur, and these cannot always be resolved with further surgery.
TGA investigates Australian adverse event reports for urogynaecological meshes and consults an expert panel. It is agreed that the TGA will continue to monitor mesh reports and emerging clinical evidence.
TGA and NZ Medsafe seek advice from the Medical Device Incident Review Committee. The committee emphasises the need for informed patient consent and surgeon training when using such devices.
US-FDA releases statement: a literature review demonstrates conflicting information on the success rates for transvaginal mesh placement and further investigation is required.
Health Canada releases a notice to hospitals informing healthcare professionals of the complications associated with urogynaecological mesh.
TGA undertakes a targeted postmarket review of specific urogynaecological meshes in response to a report that meshes are difficult to visualise once implanted.
FDA releases an updated communication advising that adverse events a no longer considered rare, there is no compelling evidence of greater success with mesh in posterior compartment, and some evidence of greater efficacy in anterior compartment. All patients should be advised that long-term data on safety of mesh is limited and alternatives to mesh should be discussed.
US-FDA issues orders for manufacturers to conduct postmarket surveillance
TGA publishes a web article, Concerns with urogynaecological surgical mesh implants
TGA commences a comprehensive postmarket review of published literature for urogynaecological meshes
Australian Department of Health establishes a Urogynaecological Devices Working Group to consider the available clinical evidence and to contribute to the postmarket review activities being undertaken by the TGA
TGA commences a broad review of all urogynaecological meshes available for supply in Australia.
Health Canada issues an updated notice to hospitals and patients advising that Health Canada continues to receive reports of complications, including some serious and life altering events.
Scottish Cabinet Secretary for Health and Wellbeing appeals to NHS Scotland to suspend transvaginal mesh procedures pending the outcome of an independent review.
The MHRA releases a statement that there is no regulatory justification for removing surgical mesh from use in UK hospitals.
TGA reports on the postmarket review into all urogynaecological meshes available for supply in Australia and there is a significant reduction in the number of urogynaecological meshes available on the Australian market.
New Zealand report into the safety of surgical mesh is published
Scottish independent review into urogynaecological mesh – interim report is published
NHS England Releases the Mesh Working Group Interim Report.
European Commission (SCENIHR 2015) report into the safety of urogynaecological meshes suggests limiting mesh surgical procedures wherever possible, certification systems for surgeons, and appropriate patient selection and counselling.
A Cochrane Review is released comparing mesh to native tissue repair for POP and reports that while permanent mesh has some advantages over native tissue, there are also disadvantages in its routine use.
The Lancet publishes a Scottish multi-centre trial into urogynaecological mesh (PROSPECT study). It finds no benefit in using mesh for surgical treatment of POP in comparison to traditional surgical methods. TGA is considering taking appropriate regulatory action.
FDA reclassifies urogynaecological POP mesh as Class III – a high risk device. Manufacturers are given 30 months to provide updated evidence. The reclassification does not apply to all implantable meshes.
NZ House of Representatives Health Committee releases a report that includes a recommendation for the establishment of a centralised surgical registry. RANZCOG releases a response welcoming the report and the recommendation that meshes remain available as a surgical option.
The Australian Pelvic Mesh Support Group meets with Ministerial Advisors and senior Department of Health officers. This meeting includes discussion on how to encourage patient adverse event reporting in Australia.
TGA publishes a web article urging the reporting of adverse events relating to urogynaecological surgical mesh.
Health Canada considers powers to require mandatory reporting of adverse events by healthcare institutions – Vanessa’s Law.
RANZCOG publishes a statement advising that transvaginal mesh is not recommended as the first line of treatment for any vaginal prolapse. Surgeons should consider clinical trial recruitment for use of any new mesh types.
The EU confirms regulatory reclassification of all surgical mesh to Class III and Australia proposes to commence the regulatory process to reclassify all surgical meshes as Class III (the USA the reclassification of meshes which occurred in 2016 is limited to urogynaecological mesh used in POP).
Scottish independent review into urogynaecological mesh – final report published
4 July 2017 a class action against Johnson & Johnson Medical Pty Ltd and Ethicon commences in the Federal Court of Australia.
30 November 2017, the TGA announced that it had decided to remove transvaginal mesh devices solely used for the treatment of POP from the Australian Register of Therapeutic Goods (ARTG). In making this announcement, the TGA advised that, following a review of the latest international studies and the clinical evidence for each product, it was of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks the devices pose to patients. The ACSQHC reached a similar conclusion in September 2017.
17 January 2018, the TGA announced that it had amended the information that must be provided to consumers about adverse events associated with urogynaecological mesh implants, such as severe chronic pain, groin pain and bladder perforation, in the device instructions for use of the product. Two sponsors chose to update the information and a third sponsor — Johnson & Johnson — elected to withdraw its devices from the market. This left seven entries on the ARTG for urogynaecological mesh and 14 devices remaining.
New report: a damning indictment of health system’s failure to care for women
The Senators inquiring into the use of transvaginal mesh implants in Australia were very clear about their intentions.
They wanted their report to enable people to hear and learn from the experiences of women who’d been harmed – by the mesh implants, as well as by the subsequent responses of health professionals, systems and regulators.
The Senate Community Affairs References Committee report makes for harrowing reading, recording the emotional and physical traumas of hundreds of women who shared often deeply personal stories.
“The committee has sought to place these women at the forefront of this inquiry,” says the report – while acknowledging evidence “that the vast majority of women who have had transvaginal mesh procedures as part of treatment for stress urinary incontinence (SUI) or pelvic organ prolapse (POP) have not experienced complications as a result of their surgery and have experienced improved quality of life.”
The Senators state: “The committee considers that it is of no consolation to women who have lost so much to be told that they are part of a very small minority.”
The report also records the Senators’ damning assessment of health professionals and services involved in the cases they considered: “Even allowing for the positive accounts provided to the committee and the fact that some accounts are recalling events of over ten or fifteen years ago, they present the medical profession in a very poor light.”
Since beginning the inquiry in February 2017, the committee received 555 submissions and said they had been “struck by the extent to which women who have had adverse experiences following transvaginal mesh surgery have struggled to be heard as they have sought to raise concerns about their symptoms”.
The vast majority of more than 500 women who wrote to the committee had experienced adverse events following surgery to implant surgical mesh.
The committee said they received “many accounts describing the challenges and frustration that patients have faced in having their symptoms addressed, or indeed taken seriously”, and that these struggles to cope with their symptoms and to find support and treatment have had “far reaching and devastating impacts on their lives and the lives of their families”.
Some women had waited years for recognition and treatment to address their symptoms, “all the while suffering debilitating pain, physical limitations, social isolation and financial and emotional stress”.
“Sadly many women recounted being spoken to angrily or disrespectfully when they have asked questions about their symptoms and spoke of feeling humiliated, embarrassed and upset… Other women have been told that their symptoms are imagined.”
Dismissive and disrespectful
Committee members said they could “find no reasonable justification for the dismissive and disrespectful treatment many women have experienced from trusted medical professionals”.
They cited Stella Channing of the Australian Pelvic Mesh Support Group, who told the committee: “To add insult to injury, many women who have gone for consultations have been scoffed at, mocked, humiliated and disregarded by some of their doctors”.
These comments, invalidating women’s lived experience, showed “how the health system silences, shames and blames the victims,” Channing said.
The committee also expressed deep concern “about the inconsistent and at times cursory manner in which consent has been obtained”, and said that “many women appear to have received little or no information to assist them to make a decision or provide their informed consent”.
The Senators were “dismayed” by reports some women had not been told they had received a transvaginal mesh implant as part of treatment. As well, some were not informed that the implant is intended to be permanent and can be difficult to remove.
One woman who had transvaginal mesh surgery in 2004 to address minor incontinence told the committee of her horror when she learnt that the mesh was permanent.
The report cites a Consumers Health Forum submission that there had been “a catastrophic failure of the health system to protect women and ensure they have access to safe health care”, and that women had “been let down by their doctors, by the manufacturers of mesh and by the TGA [Therapeutic Goods Administration] as the regulator”.
The committee members said they encourage “women not to accept unprofessionalism by medical practitioners and to consider reporting any concerns they might have, either to the medical practice or hospital, or in the case of more serious complaints, to the health care ombudsman in the relevant state”.
They agreed with a Public Health Association of Australia description of the complications resulting from transvaginal mesh implants as a serious public health issue requiring a response at an individual and a population level – including counselling, public education, clinical interventions and long-lasting protective mechanisms.
The report includes many distressing accounts from women of the wide-ranging impacts upon their health and lives, including their relationships.
Symptoms include chronic vaginal pain and recurrent urinary tract infections. Many woman told of experiencing mesh exposure or erosion – the protrusion of mesh fibres through the vaginal wall, which can lead to discomfort and pain, including bleeding and pain during intercourse, as well as infections, adhesions to the bowel and bladder and faecal incontinence.
Stella Channing told the committee:
The women have lost their health, and in many cases they have lost their jobs, their careers, their homes and, in some cases, their husbands. The pain and complications cause them to be isolated from their friends and families, and many suffer from depression, anxiety and PTSD. Many women are shocked and in despair when they realise that they will probably never regain their health or their life back.
The Women’s Health and Research Institute of Australia told the committee that “often words cannot convey the degree of human suffering we are seeing”.
Many women said they had withdrawn from social and family activities, too embarrassed to explain their symptoms to friends and family and unable to engage in work or normal social activity. Others told of their inability to care for their children or interact with their grandchildren.
The committee was struck by how many women reported the breakdown of their marriages; many found it extremely painful or impossible to sustain an intimate relationship after the surgery, and spoke of the emotional pain and grief involved.
Many women told of the financial toll of needing treatment for complications from mesh surgery, including for pain management, scans, and incontinence and mobility aids.
Women had used up their leave, drawn upon their superannuation, sold valuables and, in some cases sold or mortgaged houses and drawn on the generosity of friends and family to fund their treatment.
Some had travelled overseas to have the mesh devices removed.
Meanwhile, the committee heard that some hospitals have been charging patients to release medical records.
Background to the inquiry
A timeline at the end of this article describes the history of transvaginal mesh implants, a form of urogynaecological mesh that is implanted in a surgical procedure via an incision in the vagina or abdomen to address pelvic floor conditions.
The mesh is a synthetic net-like substance designed to provide extra support to repair weakened and damaged internal tissue. Its holes allow the body’s own tissues to grow into the mesh.
Mesh devices for the treatment of stress urinary incontinence (SUI) or pelvic organ prolapse (POP) are usually made from the same material, but the procedures to implant them are different and each has different risks and benefits.
The report says the prevalence and severity of problems associated with transvaginal mesh implants has risen since the first adverse event was reported in Australia in 2006. These can occur immediately after surgery or take years to manifest.
Class actions have been initiated against manufacturers and suppliers of urogynaecological mesh devices in a number of countries, including the US, UK, and Canada.
Internationally, women have been at the forefront of efforts to lobby for reviews of the use of transvaginal mesh, leading to inquiries in New Zealand, Scotland, England and other countries.
In 2016, the latest update of the Cochrane systematic review of clinical publications of evidence on the use of mesh for POP concluded that mesh “might be useful for particular individual women, who might be willing to accept the risks, but that there was limited information regarding the benefits and risks and more research was needed”.
The Senators’ report highlights the complexity of regulatory and oversight arrangements for the mesh devices, involving the TGA, the medical colleges and the Australian Commission on Safety and Quality in Health Care (ACSQHC).
The TGA undertook its first post market review of urogynaecological meshes in 2008, in response to a United States Food and Drug Administration safety alert.
Professional colleges influence the standard of care delivered by practitioners through education and training, the provision of guidance for the management of clinical conditions in women’s health and standards for professional behaviour and research.
However, while the colleges can guide and advise, they have no regulatory role in relation to standards of clinical practice, outside auditing doctors’ compliance with continuing professional development. Credentialing of individual doctors is the responsibility of credentialing committees within individual hospitals.
Limitations with data sources meant the committee could not make a definitive finding on how many women have had transvaginal mesh implants in Australia, although one expert estimated that between 150,000 and 175,000 transvaginal mesh procedures had been performed for POP and SUI.
Nor could the committee establish how many women had experienced complications.
However, it is clear that adverse events have been significantly under-reported to the TGA, with the Health Issues Centre recording that 2,400 women had provided it with personal accounts of adverse events by August 2017.
Data provided by Medibank indicated that, in the years 2012-2013, four per cent of patients insured by Medibank who had transvaginal mesh inserted had a readmission within the next three years for a complication associated with that implant.
The committee said it was concerned that under-reporting of adverse events associated with transvaginal mesh products had “provided a false indication of the safety of such devices and contributed to delays in responding to the issues identified. The committee is deeply concerned that this has resulted in more women suffering complications.”
The committee heard a range of evidence regarding the interactions between device manufacturers or sponsors and medical practitioners. Such concerns ranged from questions over the presence of sponsor representatives in the surgical theatre to the possibility of financial inducements to medical practitioners to use specific products.
The committee notes widespread support for the establishment of a national register of medical devices and said such work currently underway through COAG should be prioritised.
The committee recommends the TGA take action to educate and encourage doctors to report adverse incidents associated with the use of medical devices, and recommends that the Department of Health and Ageing introduce mandatory reporting for health practitioners to the TGA on relevant issues, including problems with medical devices.
The TGA and the ACSQHC should develop an information sheet for recipients of patient cards for implantable devices providing guidance on appropriate action if an adverse event occurs.
The committee welcomed recently announced measures to increase the level of pre-market scrutiny of surgical mesh devices, and requirements to increase the level of information available to consumers regarding medical devices.
The committee said TGA moves to restrict the use of transvaginal mesh for POP meant the mesh would in effect only be available under a special access scheme and will limit the ability of medical professionals to use transvaginal mesh for the treatment of POP except in certain circumstances.
The committee recommends that the Department of Health work with the Medical Technology Association of Australia and the Medical Board of Australia to review the systems in place within the device manufacturing industry and the medical professions to support consistent, high ethical standards, with specific emphasis on systems in place to prevent the payment of inducements to medical professionals and teaching hospitals.
It also recommended that Commonwealth, states and territory governments commission the ACSQHC to do an audit of all transvaginal mesh procedures undertaken in Australia, and their outcomes.
Other measures in train
The committee notes that the ACSQHC is finalising resources on the symptoms of POP and SUI together with the range of treatment options available, and is also developing care pathways for these conditions, and for the removal of transvaginal mesh.
The ACSQHC has also developed guidance for the credentialing and training of senior medical practitioners who implant transvaginal mesh for the treatment of POP and SUI and also for the removal of transvaginal mesh.
The ASQHC advised the committee that each state and territory is reviewing the provision of services for the use and removal of transvaginal mesh, and some have developed specific information resources and support services, including dedicated telephone information and referral services.
The report said the ACSQHC should also develop guidance material on effective informed consent.
“There is also a clear need to improve the communication skills of some medical practitioners to ensure that they are communicating effectively with, and listening to patients,” the committtee said.
The Consumers Health Forum said the report highlighted the need for rigour and scrutiny in the introduction of medical devices such as mesh, the requirement for effective training including for the possible removal of mesh devices, and close surveillance of the performance of such products.
The Forum’s CEO, Leanne Wells, said: “We support the position that mesh should be the last resort and other measures should be fully explored first. This is not to deny women the choice of having a mesh implant but this must be linked to improved informed consent.”
She acknowledged that the TGA had already begun work on introducing patient device cards and consumer device information leaflets, which will begin to take effect with new urogynaecological devices from 1 December.
A statement by state and territory based health consumer organisations welcomed the report’s recognition of the extent and impact of harms to women, but said they had hoped the report would have gone further.
“We are disappointed that a more cautious approach wasn’t taken, to recommend the suspension in use of all mesh until the data is in to establish their safety and efficacy,” said Melissa Fox, CEO of Health Consumers Queensland.
“These devices will continue to be implanted in women in hospitals across Australia tomorrow, and not one more woman should be unwittingly subjected to this high-stakes surgical intervention until we can be assured of their safety.”
However, she welcomed the report’s recommendations for strengthened provisions for informed consent, only using mesh as a last resort, requiring mandatory reporting of complications, establishing a register and having the ACSQHC do an audit of transvaginal mesh procedures in Australia.
“The Commission must be resourced to do this in a timely manner and the audit should also include procedures done by private specialists,” she said.
Mesh 101: The Basics
For women who have received a transvaginal pelvic mesh implant and have developed complications since then, they are often told “it’s in your head,” or “mesh can’t cause pain.”
These pages are full of thousands of anecdotal reports from women who would argue that point- their mesh implant has caused them real pain and a life-altering complications that sometimes are permanent.
Pelvic mesh, sling, transvaginal mesh, TVT, hammock- some of the names for transvaginal mesh. This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today!
Becoming your own best advocate and knowing the facts will help you navigate the road ahead!
How Did We Get Here?
“It is just so unbelievable that a “minor problem” outpatient procedure that is minimally invasive causes life changing results. I know my life as I knew it is gone.”~ mesh injured patient
Transvaginal mesh means it is placed through the vagina. This procedure called “minimally invasive” which is a marketing term, and it’s done to suspend pelvic organs that may prolapse through the vagina, a fairly common condition in women as they age, after multiple vaginal births, due to a hysterectomy, as a result of surgery or due to weak collagen.
Pelvic organ prolapse is known as POP.
Many different organs can prolapse in a woman and they include:
Urethrocele– lower vaginal wall and urethra;
Cystocele-upper vaginal wall and bladder;
Uterovaginal – uterus, cervix and upper vagina;
Rectocele– lower posterior vaginal wall and rectum;
Enterocele – upper posterior vaginal wall and small bowel. POP is measured in four stages from zero to 4.
Page four and five of this FDA page shows the female anatomy and what can go wrong.
These are embarrassing conditions many women do not want to talk about. That’s why I called my original series “Suffering in Silence.” The four-part series from 2009 begins here.
Mesh is also increasingly being implanted in women following a hysterectomy, sometimes prophylactically to prevent a possible future prolapse.
Another condition treated with mesh is stress urinary incontinence (SUI) which occurs when urine leaks during physical activity, coughing, sneezing or laughing. It’s estimated about 13 million American women experience SUI. Mesh to treat SUI is more common than POP mesh.
It’s estimated upward of 60 percent of women will suffer from one or both of these conditions in their lifetime and the FDA reports that in 2010 about 300,000 women had surgery to repair POP with about 3 out of 4 done transvaginally. Market data also shows that 80 percent of the 260,000 SUI surgeries done in 2010 were done transvaginally with mesh.
Transvaginal or abdominally-placed mesh for POP or SUI is intended to be a permanent implant, despite the fact that there were no studies required by the U.S. Food and Drug Administration for safety and efficacy!
That’s right, none.
The majority of medical devices make it to market via the 510(k) approval process, which is essentially an “approval” to sell. All a manufacturer has to do is to say their device is the “substantial equivalent” of another device already on the market. Exchange paperwork, a few thousand dollars, about 60 to 90 days and Voila! Your device is generally approved by regulators at the FDA.
Did your implanting physician tell you the FDA had issued two warnings about polypropylene mesh in the U.S? Health Canada has also issued warnings.
Polypropylene is derived from petroleum and was developed in the 1950s as a thermoplastic polymer resin that can be molded into many forms. Mesh manufacturers molded the plastic into fibers for sutures. Polypropylene knitted mesh using monofilament yarns make textile fabrics and indoor-outdoor rugs.
Synthetic mesh was first used for hernia repair in the 1950s but sometime in the 1990s it began to be used for POP and SUI. By 1996 the FDA cleared the first surgical mesh product for use in SUI and in 2002 for use in POP. The introduction of pre-cut “kits” corresponded with weekend cadaver training sessions offered by mesh manufacturers.
Gynecologists, were schooled by the manufacturers how to implant the plastic mesh with the aid of a kit including pre-cut mesh, needles and sutures.
Almost immediately complications were noted. From 2005 to 2008, the U.S. Food and Drug Administration noted it had received more than 1,000 reports of complications associated with mesh.
They can include:
- Erosion through the vaginal epithelium and tissues;
- Perforation of bladder, rectum,
- Urinary problems;
- Internal bleeding;
- Recurrence of prolapse and/or incontinence;
- Vaginal wall narrowing
- Nerve entrapment
- Vaginal scarring;
- Dyspareunia (painful sexual intercourse)
“I’m so tired from the struggle & the wait for proper medical attention. My heart is growing weary after five years I am getting worse & scream out to even get up & set down . The getting up is worse , I draw double holding my lower abdominal area where there is an open hole that bleeds.”
By October 2008 when the FDA issued a Public Health Notification concerning transvaginal mesh, it said there were more than 1,000 reports of “adverse events,” as the FDA calls complications. The events were serious but “rare,” according to the FDA. See the FDA 2008 Public Health Notification here.
Then in July 2011, the FDA (here) reported that complications associated with transvaginal mesh to treat POP increased five-fold; that “serious complications associated with surgical mesh for transvaginal repair of POP are “not rare” and that transvaginal mesh used for POP repair “does not improve symptomatic results or quality of life over traditional non-mesh repair.”
It was after the second FDA warning that product liability or defective product lawsuits began to be filed.
Nine manufacturers are the focus of litigation, they include: Johnson & Johnson (Ethicon, GYNECARE), C.R. Bard, American Medical Systems, Boston Scientific, Endo Pharmaceutical Holdings (AMS), Caldera and Covidien, among others.
The FDA issued a White Paper “Urogynecologic Surgical Mesh” about the same time which is an excellent resource here.
See Diana Zuckerman from the Center for Women and Families, and her excellent piece on 510(k) published in the Archives of Internal Medicine here.
If you a re experience some of these symptoms, you may want to reach out to an attorney, please click here.
The Problems: Recalls
Even today women are often told the “bad mesh is off the market.” In most cases this is misleading because the vast majority of meshes are still on the market, even the ones that have been found defective in a court of law!
Those would include the TVT-O (transobturator tape) and the TVT (transvaginal tape).
In June 2012, Ethicon (Johnson & Johnson) announced it was discontinuing the sale of four synthetic transvaginal meshes from its Gynecare division. Here is background story from Mesh Medical Device News Desk.
This was not a recall. J&J said it was making the move for financial reasons.
What was recalled was the ProteGen, a mesh made by Boston Scientific which was the “predicate” named by many of the meshes on the market today. It was found not to functions as intended, in other words it was defective. A great resource on the ProteGen predicate was done by a mesh injured woman who I’ve found to be very credible and an excellent researcher. It appeared on iCNN here.
However, that finding about the ProteGen did NOT spark a re-review of all of those meshes that had named it as their predicate device. Sort of like a generation of Pinto-like cars being left on the market after the Pinto was recalled!
The federal court began consolidating mesh cases in Charleston, WV in January 2012. This is called multidistrict litigation (MDL) and it is intended to smooth the process for the background research of these cases (called discovery) and to have consistent court rulings.
In an MDL, you are awarded any settlement monies based on your degree of injury, unlike a class action where everyone gets an equal slice of the pie.
But the pace of this litigation has been very slow. So far “bellwether cases” so named for the bell on a lead sheep, which are supposed to test the waters on legal theories and have both sides come to an agreement, have been few and far between. There are now, in early 2016, more than 86,000 case filed in this federal court in Charleston before Judge Joseph Goodwin.
An MDL has never had so many cases filed in one court and frankly the court cannot handle it.
The cases that have been heard are generally favorable to the plaintiff- the woman- who is awarded anywhere from $2 to $100 million. (that number was later reduced to $10 million). Immediately after a jury verdict, the defendant mesh maker will file an appeal. So far only one plaintiff who went to trial has received her compensation.
Right now it appears to be a waiting game with the largest mesh maker, Johnson & Johnson, which is slow to the settlement table and instead has opted to defend itself in court. Other mesh makers have settled cases, though settlement dollars are usually disappointing and not intended to fund a lifetime of medical needs.
From the FDA front, the FDA decided to give mesh makers 30 month to prove their products are safe and effective ( something that might have been done before approval!) or they will have to come off the market. This applies ONLY to POP mesh NOT to SUI mesh. It is assumed mesh makers will have quite the challenge to prove safety so it remains to be seen whether POP mesh will survive. Unfortunately, they have 30 months to continue to use it.
Mesh for incontinence (stress urinary incontinence or SUI) will be allowed to stay on the market. Mind you that there are far more defective product lawsuits filed over SUI mesh, incontinence mesh.
The FDA had stated it would watch the complication reports from SUI mesh instead. Last time this reporter asked, the FDA told me they didn’t know how many injuries were they were receiving concerning SUI mesh.
How to Report an Adverse Event:
Have you ever been curious how the FDA is handling the mesh mess?
Here is where you put in mesh, surgical, polymeric (here). You will pull up many reports made to the FDA about mesh. You can make the report, or your attorney. Make the report then follow up and see if it matches your narrative.
So that leads to this- How to report your injury to the FDA! This is very important to do.
First, know what brand mesh you have (Boston Scientific, Ethicon/J&J/ Gynecare- all J&J). You will get this from your medical records. Get those records!
So how do you report to the FDA? Here is a story from August 2014.
You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:
- By phone- 1-800-FDA-1088
- By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
- By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
MedWatch Online Voluntary Reporting Form (3500) is here.
Look up Adverse Events:
Manufacturer and User Facility Device Experience (MAUDE) data
As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.
For example, in the case of mesh patient, Suzanne McClain (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:
1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
2.) Brand Name: Tension Free
3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
4.) Records Per Report Page: Change to 500 and click Search.
The Problems: How Women are Treated
POP and SUI are considered “conditions” and are an inconvenience, generally not painful, but are embarrassing. Most women do not talk about the condition and many find it embarrassing even to talk about complications that result from surgery.
That may be one reason the surgery option continues today – women are embarrassed to speak to their doctor about complications. Symptoms may be general in nature and the woman may not associate her symptoms with mesh and doctors who receive their primary education from the mesh makers and their sales reps may not be equipped to handle complications.
Women suffering after a mesh implant often hear, “You’re the only one who is having these problems.” Women suffering complications are frequently told they are depressed and told to visit pain management and to take antidepressants. Many women talk of unending chronic pain, infections and a continuing denial from their doctors.
These stories are repeated over and over.
Editors Note*- the story on Mesh 101 is designed for those women who are just developing symptoms and do not know where to turn. You may want to reach out to legal counsel. ###