Wednesday, September 28, 2011

Vaginal Mesh Surgeons Respond to FDA

A group of surgeons has recently published their collective response to the 'Safety Communication Update' provided to the FDA by an advisory committee, regarding the use of transvaginal placement of surgical mesh (TVM) for pelvic organ prolapse (POP).  You can read the entire report here:

Earlier this month, the advisory committee concluded that these mesh devices do not need to be reclassified from Class II to Class III.  While the committee acknowledged that there are very real and significant risks involved with these devices, they did not find enough evidence to reclassify them.  Basically, any device that is classified as Class III may be required by the FDA to undergo a series of randomized trails that demonstrates its safety and efficacy; whereas, Class II devices are not nearly tested to such high standards.  

The surgeons do agree with the FDA that implantation of mesh does carry such risks as mesh erosion, pain, infection, bleeding, pain during intercourse, organ perforation, and urinary problems but they take issue with one of the quotes from the FDAs most recent update:  “Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.”  This group of surgeons argues that patients should be aware that with the exception of mesh erosion, these are all risks of traditional non-mesh surgery as well.  In other words, they feel that the FDAs statements imply that there are multiple risks of TVM that do not exist with traditional repairs and they feel that this is not accurate and is misleading to the public.

Well, all POP surgical procedures carry a certain level of risk and all methods of treatment will have its share of complications.  But the question is about mesh and if the benefits outweigh the risks.  When the surgeons say "...with the exception of mesh erosion…" they change the discussion.   The FDAs advisory committee didn't meet to discuss POP repair 'with the exception of mesh erosion'; they met to discuss mesh and mesh erosion and if the benefits of using mesh outweigh the risks.  It's not entirely clear what the motivation is of this report and it's not clear how many surgeons assisted in writing this report or how many agree with it.

If you are interested in seeking recovery from the manufactures of these mesh devices that caused you pain, please contact a vaginal mesh lawyer.  We suggest finding an attorney who will not make you part of a class action lawsuit and one that that is knowledgeable and successful in this type of complex litigation.

Tuesday, September 13, 2011

Vaginal Mesh Update

An advisory committee, appointed by the FDA, met late last week to determine whether the approval process for mesh devices should be left in place.  The mesh devices in question are used to treat women with urinary incontinence, pelvic organ prolapse, or a general weakening of vaginal tissues.  In these and similar cases, the mesh implants are implanted to strengthen these weakened tissues. 
The advisory committee determined that (though no formal vote was conducted) the devices do not need to be reclassified but that additional data would be useful.  "The FDA does not believe that mesh used for SUI repair should be reclassified from Class II to Class III," the committee stated.  Any device that is classified as Class III may be required by the FDA to undergo a series of randomized trails that demonstrates its safety and efficacy; whereas, Class II devices are not nearly tested to such high standards.
What is rather shocking, is that the panel expressed numerous safety concerns and the majority supported reclassifying the devices from Class II to Class III after the first day of their two day meeting; however, by the end day two, the panel indicated that a reclassification was not necessary.  Further, the FDA back in July, warned doctors and patients to avoid mesh products. Stating, "…the transvaginal placement of surgical mesh to treat POP may carry more risks than other surgical options, without any evidence of greater benefit."  It is important to note that while the FDA is not required to follow the advice of its advisory committee, if often chooses to.
Whether or not this device gets reclassified is moot at this point anyway for many.  Both the FDA and their advisory panel have made strongly worded statements against using these devices and have documented the undue risk of using them.  For those who have already had such procedures and have experienced complications, as thousands of other women have, a reclassification doesn't change anything.  It is logical (after speaking with your physician of course, as your health needs to be your top priority) to seek the advice of a professional on how to cope with the distress of this unnecessary pain.  Should you choose to seek the assistance of a qualified vaginal mesh attorney, remember that in some cases the manufacturers of these devices may have known about the risks of their products but chose not to disclose them.  These companies need to be held responsible for these decisions that have negatively affected so many.

Tuesday, September 6, 2011

Vaginal Mesh – Advisory Committee to Meet This Week

A committee has been established (Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee) to make recommendations and to provide advice to the FDA.  On September 8th and 9th the committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for the repair of pelvic organ prolapse (POP). 

Many adverse effects have been documented with these mesh products.  The committee will be asked to provide evidence of the risks and benefits of these products and if the benefits outweigh the risks when compared to alternative treatments that tend to have fewer complications.  These implants have been used for years to treat urinary incontinence, pelvic organ prolapse, hernias, and to support weakening of vaginal tissues due to childbirth.  In 2008, it came to the attention of the FDA that a substantial percentage (as high as 10%) of recipients of these mesh implants have, or will, experience complications.  The FDA recently warned against using these devices until an advisory committee could be organized to discuss their findings further.  These advisory meetings will be held later this week in Gaithersburg, MD. 

If you have not undergone a procedure involving transvaginal mesh implants and are exploring your options, perhaps the hearings that take place this week will be enlightening.  If you are a recipient of one of these implants and you have not had any adverse side effects, again, hopefully you can gain a better understanding of risk factors and what you can expect going forward.  If you are a recipient of one of these implants and you have had adverse side effects, talk to your physician as soon as possible.  There are treatment options available but they do vary in their effectiveness depending on the severity of your personal situation. 

If you are one the many women who have experienced pain or discomfort from a mesh implant, you owe it to yourself to seek additional recovery.  In our litigious society the thought of another lawsuit might be a turnoff but think of it in the following way.  Oftentimes  manufactures/corporations/businesses/etc make decisions based on profitability.  In some cases they have even do so at the expense of being negligent.  If your pain was caused by a negligent company who only cared about increasing their bottom line, do you really think you owe them the consideration and empathy that was not shown for your well-being?  It is imperative that you speak with a qualified vaginal mesh lawyer to discuss your options.  There is no cost to have a simple conversation just to see what options are available to you.  In many cases you can play a large role in protecting future consumers to ensure that all of the necessary precautions have been put into place to increase the safety of everyone.  Even though this is foremost a health issue, sometimes negligent companies only pay attention when it becomes a financial one.

Monday, August 29, 2011

Transvaginal Mesh Recall, Requested by Public Citizen

Public advocacy group, Public Citizen, has just petitioned the FDA to ban all surgical mesh products for use in transvaginal repair procedures and for the manufactures to recall their products on the market today.   Public Citizen claims that these mesh devices expose patients to unnecessary risk without providing benefits above and beyond safer alternatives.

Public Citizen claims that about 75,000 women had prolapse surgery last year that involved some form of mesh implant.  Public Citizen's Dr. Michael Carome is quoted as saying,"Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately."

This is true.  Last month, the FDA made harsh statements against these products and advised against using them.  Deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, Dr. William Maisel, "There are clear risks associated with the transvaginal placement of mesh to treat POP." 

The timing of this recall request is notable, as advisory panel members of the FDA plan to meet on September 8th to further discuss the efficacy and safety of such mesh devices. 

Mesh erosion is the most commonly reported problem associated with transvaginally implanted mesh devices and can cause considerable pain and discomfort as well as bleeding and infection.

Tuesday, August 16, 2011

Alabama Lawsuit Filed Against Vaginal Mesh MFGs.

An Alabama woman recently filed a product liability lawsuit against vaginal mesh manufacturers Boston Scientific and American Medical Systems (AMS).  She originally sought vaginal mesh implantation to treat pelvic organ prolapse (POP) and stress urinary incontinence. 

Specifically, the devices named in the lawsuit are the Elevate Anterior & Apical mesh systems by AMS and the Pinnacle Posterior Pelvic Floor Repair Kit & Solyx SIS System by Boston Scientific.

Allegations surrounding these and similar mesh implant products (primarily those that were surgically implanted transvaginally) all suggest the same thing – that the mesh products were defective and that the manufactures knowingly kept selling and marketing these products despite their unnatural rate of failure.

The FDA just recently made statements warning of the risks of vaginal mesh implants and advised against having these products implanted.  Advisory panel members of the FDA plan to meet on September 8th to further discuss the efficacy and safety of such devices.

When seeking recovery from companies that caused injuries, especially in product liability cases, it is important to contact a knowledgeable and experienced attorney.  It is important that you contact a vaginal mesh lawyer that will not make you part of a class action lawsuit; one that will give you the attention that your individualized situation requires.

Monday, August 1, 2011

Symptoms of Pelvic Organ Prolapse

Symptoms of Pelvic Organ Prolapse (POP) include all or some of the following:
  • A feeling of pressure from pelvic organs pressing against vaginal walls.  This is the most common symptom.
  • Incontinence - the uncontrollable release of urine and/or frequently having the need to urinate.
  • A feeling of fullness in your lower abdominal region.
  •  Pain in your lower back or groin area.
  • Painful intercourse.  This can actually occur for both partners, especially if the mesh implant has started eroding.
  • Constipation. 
  • A feeling of something falling out of your vagina.
If you think you have a pelvic organ prolapse, it is critical that you visit your gynecologist or general physician as soon as possible.

Thursday, July 28, 2011

Vaginal Mesh Lawsuits filed

More than 400 lawsuits have been filed in New Jersey state court against Ethicon, Inc.  and Johnson & Johnson (Ethicon, Inc. is a wholly owned subsidiary of Johnson & Johnson). 

The complaints allege that Johnson & Johnson was aware that their products were risky and dangerous but continued to manufacture and market them.  The specific line of mesh products in question were: Gynecare Prolene mesh, Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare TVT sling and other pelvic mesh product manufactured by Ethicon. 

Some of the symptoms reported by patients of these mesh products include infections, pelvic pain, urinary complications, and erosion of the mesh device.  Earlier this month the FDA officially advised against using these mesh products as a means to repair pelvic organ prolapse or for weakened vaginal tissues due to childbirth, hernias, etc.   
Johnson & Johnson isn't the only company under fire for manufacturing and marketing their transvaginal mesh products.  C.R. Bard, Boston Scientific, and American Medical Systems (AMS) have also allegedly manufactured defective mesh products.

There are two important steps to take if you have been negatively impacted from your transvaginal mesh implant.  First and foremost, it is critical that you visit your physician as soon as possible.  Second, if you're interested in seeking recovery from the company that is responsible for your injury, you will need to speak with a successful injury lawyer; preferably a vaginal mesh injury lawyer with a track record of maximizing settlements for their clients.

Wednesday, July 27, 2011

Vaginal Mesh Failure Rate - 10%

The FDA is now reporting that up to 10% of vaginal mesh implants have been eroding and have officially advised against using them. 

Often times, medical devices don't require the same scrutiny and approval process as prescription drugs and can be rushed to market without adequate testing (note: this excludes devices that are considered 'most risky' such as pace-makers and breast implants). 

As unfortunate of a situation as vaginal mesh implants have become, hopefully some good will come out of this.  There needs to be greater oversight and consumer protections in place to protect against future incidents involving medical devices.

Over the last 5 years, there have been over 100 recalls on medical devices that the FDA cleared.  Of those 100 recalled devices, only 21 required patient testing before receiving their approval.

In 2010 alone, there were over 100,000 vaginal mesh implant patients in the United States. 

If you have experienced any pain or discomfort from your vaginal mesh implant, it is important that you visit your physician as soon as possible.  If you're interested in seeking additional recovery from your injuries, it is advisable to speak with a qualified vaginal mesh lawyer, preferably one who offers free consultations and one that doesn't try to make you part of a class action lawsuit.

Tuesday, July 26, 2011

FDA Alert - Vaginal Mesh

On July 13th 2011, the FDA issued a safety communication regarding 'Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse'.

In other words, serious complications have been linked to the use of vaginal mesh or transvaginal mesh.  As discussed previously, this vaginal mesh is an implant used to strengthen vaginal tissue that can weaken due to childbirth, hernias, etc.  According to the FDA, the purpose of their "serious concerns" are specific to pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  

The most common complication that was reported for these vaginal mesh implants was an erosion of the device through the vagina, also known as a protrusion.  The vast majority of these reports came between 2008 and 2010.

Some of the most important revelations from the FDAs investigation (taken directly from the FDAs website) are as follows:
  • Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
  • Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
  • There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
  • While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
 Patients that experienced either mesh erosion or mesh contraction reported severe pelvic pain and/or discomfort.

If you have had a vaginal mesh implant and have suffered from any discomfort, it is important that you contact your physician immediately.  There are surgical steps that can be taken to repair this damage and/or reduce the pain or discomfort.  If you are interested in legal remedies from such complications, it would be best to speak with a vaginal mesh lawyer.

If you have not had a mesh implant but are considering doing so, please be aware of the alternatives (such as biologic grafts) as well as asking your physician the appropriate questions (recommended by the FDA):

  • Are you planning to use mesh in my surgery?
  • Why do you think I am a good candidate for surgical mesh?
  • Why is surgical mesh being chosen for my repair?
  • What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
  • What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
  • Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
  • If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
  • What can I expect to feel after surgery and for how long?
  • Which specific side effects should I report to you after the surgery?
  • What if the mesh surgery doesn’t correct my problem?
  • If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
  • If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
  • If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Monday, July 25, 2011

Why are Vaginal Mesh Implants used?

Vaginal Mesh Implants are used to strengthen vaginal tissue.  This tissue can become weakened, especially after childbirth, hernias, etc and the mesh implant can reinforce and re-strengthen this tissue.  

The vaginal mesh itself is porous to allow the body's own tissue to grow into the mesh. This is intended to create an even more reinforced structure.

Sometimes vaginal mesh implants are used when there is a vaginal prolapse.  A vaginal prolapse is a condition where the bladder, uterus and/or bowel distends into the vagina. 

A vaginal prolapse does not guarantee the use of a mesh implant.  Alternatively, biologic grafts can be used to re-strengthen vaginal tissues.  To determine whether a mesh implant or biologic graft was used you should consult your physician; however, generally biologic grafts were used if the surgery was performed through the the vaginal route.  If you had robotic surgery, then there is a higher liklihood that mesh was used.