Poll: Public wants strong medical device oversight

Consumer Reports Poll: Americans Overwhelmingly
Support Strong Medical Device Safety Oversight

Industry Pressure Stymies Patient Protections
In Draft House and Senate Medical Device Bills

WASHINGTON, D.C. – A new Consumer Reports poll shows overwhelming public support for strong medical device safety oversight. The poll was released just as House and Senate Committees have issued draft legislation to reauthorize the statute governing medical devices and at a time when the FDA’s process for reviewing new implants has come under intense criticism.
The House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight and should be rejected by Congress, according to Consumers Union, the policy and advocacy arm of Consumer Reports. While the Senate Health, Education, Labor and Pensions Committee’s draft bill provides some additional protections for patients once devices are on the market, it misses the opportunity to enact a clear process for preventing unsafe devices from being sold in the first place.
“Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective,” said Lisa Swirsky, senior policy analyst for Consumers Union. “Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available.”
The medical device industry has been pushing Congress to scale back oversight of implants and other devices, which it claims is necessary to promote innovation and make it easier to get new devices approved. But according to the new Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
The vast majority of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale. Instead, the FDA is limited to review only whether the device is similar to one already on the market. Ninety-one percent of the Consumer Reports poll respondents said each implant should be safety tested before being sold even when similar implants were in use, and 68 percent of those respondents thought they “definitely should” be safety tested.
Current law allows the FDA to approve a new device that is similar to an existing device even when the existing device has been recalled because of safety problems. So far, the medical devices industry has succeeded in lobbying Congress to keep this policy in place – neither the House nor Senate discussion drafts address it. However, 71 percent of the poll respondents said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
Ninety-four percent of poll respondents indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.
Similarly, 95 percent of respondents said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.
Sixty-six percent of respondents indicated a high level of concern about the safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers. Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.
One additional finding of the poll was that 17 percent said they had a medical implant and 47 percent have a family member or close personal friend with one. These findings reflect the large number of Americans using medical implants that could pose a risk of significant harm if they break, leak, stop functioning or disintegrate.
“Our poll shows that Americans support common sense reforms that would help improve medical device oversight and keep patients safe,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “The vast majority of the public wants strict requirements that ensure new implants are safe and effective.”
Consumers Union’s Safe Patient Project has called on Congress to require more rigorous safety testing before medical implants and life sustaining devices are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems arise. For more details, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet.
The Consumer Reports National Research Center conducted a nationally representative telephone survey about medical implants such as artificial joints and heart stents between February 9-12, 2012. The poll included 1,000 U.S. residents (18 and older) and was fielded by vendor ORC International. Respondents were asked their opinions about the safety, level of concern and consumer protections related to medical implants. The margin of error is + / – 3.0 percentage points at a 95 percent confidence level.
Contact: Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell) or 415-431-6747, ext 126 (office) or David Butler, dbutler@consumer.org, 202-462-6262

Article source : http://consumersunion.org/news/poll-public-wants-strong-medical-device-oversight/


Transvaginal Mesh: What You Need to Know

medical mesh
medical mesh

If you’ve had surgery to treat pelvic organ prolapse (POP) or stress urinary incontinence, your doctor might have implanted a surgical mesh product during your procedure. Almost one third of these types of procedures utilize surgical mesh, and this percentage is growing daily, despite FDA warnings and product recalls. My employment offers me a unique perspective into the disturbing world of medical products, where products can create enormous complications and their manufacturers are less than honest.

Let’s start from the beginning. POP and stress urinary incontinence operations used to be exclusively surgical procedures, where the physician would use his or her skills in order to best repair weak tissue and prevent the offending condition from reoccurring. It usually took doctors several years before they acquired the necessary experience to perform these operations successfully. Until about the 1990s, that is… when medical providers began to sell healthcare providers on what they thought was the perfect solution: synthetic mesh.

Since that time, use of synthetic mesh in POP and incontinence operations has skyrocketed, creating a tailspin of unintended consequences and lifelong complications in the patients unfortunate enough to have had one implanted in their bodies. Most mesh products are made from polypropylene, a polymer you’d commonly think of as plastic. Now here’s the crazy part: the major manufacturers create their transvaginal mesh products from the byproducts of industrial petroleum operations. That’s right. These companies are instructing doctors to implant a petroleum waste product, an entirely foreign object into women’s most sensitive areas to threat their complications.

Because transvaginal mesh products are only classified as a “Category II” of the three categories established by the FDA, they were not subject to the most rigorous testing before they were approved for use on the open market. Complications don’t always ensue after implantation, but when they do, they can be pretty nasty. Some side effects that women I’ve dealt with have reported include bleeding, chronic back pain, bloating, and pain during intercourse. Removing the mesh can be difficult as well, as tissue grows around the product after it is implanted.

If you’re worried about an operation you had, I suggest requesting a copy of your medical records immediately. That way you can determine whether or not a mesh product was used in your operation (sometimes doctors do not inform their patients of this, so be sure to check for yourself). If you’re experiencing ongoing complications, consult a doctor and discuss the feasibility of having the transvaginal mesh removed, if possible. And finally, although you might never be able to rid yourself of the terrible complications from these products, odds are good that you have a solid legal claim on your hands. Make sure you check the FDA website regularly, as it seems they are finally catching onto the true danger behind transvaginal mesh products. Be sure to get the word out so other women don’t have to potentially experience the complications that you face daily.

Knowledge is power. Finding objective information about transvaginal mesh can be daunting because it has been whitewashed for so long. But hopefully this article provided you with a solid starting point… best of luck!

More information about transvaginal mesh [http://transvaginalmeshfailure.com/] and the tools you need to file a products liability lawsuit.

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What Are The Transvaginal Mesh Problems You Can Have?

Transvaginal mesh problems can occur, but it’s a fairly common surgery. This is a health issue caused primarily from hysterectomies, difficult child birth, and even menopause. The issue is that women’s vaginal tissue begins to weaken, causing the muscle to lose its ability to hold up a woman’s internal organs. These organs, without support from vaginal tissue, begin to fall into a woman’s vagina. This causes serious health problems.

Women who need mesh implants typically begin to have issues using the restroom. They may not be able to go even though they feel they have to very badly. They may not feel they have to use the restroom and then use it without any warning. They may also have pain when walking, engaging in sexual intercourse, or using the bathroom. If this happens, a doctor will check to see if the muscles in the vagina are strong enough to support her organs. If not, she will be given a transvaginal mesh implant.

This implant is placed into a woman’s vagina and attached to the vaginal wall. Some women will only receive implants that evaporate over time. Others will receive permanent mesh implants. It all depends on what you doctor thinks you need.

Like any other surgical implant, there are complications that can occur after the implantation of pelvic mesh. For example, many women experience perforation of their internal organs. This occurs when a woman’s mesh begins to rub against organs such as her bladder or bowel, causing them to tear open and bleed. This is a potentially deadly occurrence, which needs to be treated right away. Other issues that can occur include pelvic mesh failure. This means that the mesh does not support the organs, perhaps because the vaginal wall is not strong enough to hold the mesh.

If you think that you are suffering from transvaginal mesh problems, you will want to see your doctor. Some problems are small and can be taken care of right away without much trouble. Other issues are much worse and require medical attention right away. Regardless, it’s always better to be safe than it is to be sorry, so go ahead and contact your doctor right away.

Transvaginal Mesh Bladder Perforation
One of the biggest problems associated with transvaginal mesh is bladder perforation. This occurs when the mesh inserted into a woman’s body pushes far enough into a woman’s bladder that it perforates the organ. This can cause bleeding, severe health issues, and even death. While the surgery is relatively safe, mesh implants do have a 10 percent failure rate. This is a high number, which is precisely why the FDA has recalled many different mesh implants as well as issue a public announcement regarding the safety of the products.

If you have transvaginal mesh, you will want to watch for some of the most common side effects that could indicated a perforated organ such as the bladder. The most common side effect is bleeding. You might originally think that your menstrual cycle has appeared, but the bleeding will not stop and it will not decrease in heaviness as time goes by. The blood will continue to come faster and heavier, and it should be an indication that you should call your doctor right away.

Another common side effect of a perforated bladder is pain. You might notice this pain when you sit, walk, or engage in sexual activity. The pain will worsen quickly, which is a big indicator that you have some sort of issue that needs immediate medical attention. Finally, if you have had a mesh implant, you will want to check for problems using the bathroom. You might notice that it’s difficult to urinate when you have to go. You might notice that you are using the bathroom without realizing it. The issues go on and on. Essentially, if you have a transvaginal mesh implant and you begin to notice issues when it comes to using the bathroom, call your doctor right away.

Transvaginal Mesh Urinary Incontinence
When you have transvaginal mesh inserted, it’s supposed to help you improve your bathroom usage by keeping your internal organs where they’re supposed to go. Many women with implants needed them because their bladder was falling into their vagina, making it difficult to use the bathroom. This occurs when the tissue and/or muscles in the vagina are not strong enough to support a woman’s internal organs. When they begin to sag, one of the first problems women experience is an issue using the bathroom.

With the mesh in place, there should be no more issues using the restroom. However, some women do begin to experience some side effects, including urinary incontinence. This is caused by a failing mesh implant and other problems, such as bladder perforation. Again, If you have a mesh implant and you begin to use the bathroom uncontrollably, you will need to see a medical professional right away.

What is transvaginal mesh urinary incontinence? It’s the problem women experience that causes them to urinate on themselves without control. You might feel that you have to use the restroom but simply don’t make it in time. You might not feel you have to use the bathroom and you do it in your pants without even knowing you had to go. The point is that you are using the bathroom without any control over your own bladder, and oftentimes you are not in the bathroom when this happens.

This issue is one that can be handled by a medical professional. Call your doctor right away if you notice this happening in your life. You don’t have to live a life of embarrassment or inconvenience because your having a transvaginal mesh problem. In addition, you’ll want to have this looked at immediately because it could mean that you have more issues, including a perforated bladder that could lead to some dangerous and irreversible health problems.

For more information about transvaginal mesh, please visit: Transvaginal Mesh Problems

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Surgical Mesh Implants – The Top Recommendations to Avoid Post Surgery Complications

Modern day surgery uses the principles of placing surgical mesh inside the human body to achieve the desired results. The mesh works by the foreign body principle, inciting an inflammatory reaction and then forming a fibrotic barrier which is protective for the organs. Surgical mesh is used in many procedures like herniorrhaphy, stress incontinence surgery and pelvic organ prolapse repairs. However it should be noted that research has shown a few problems associated with the use of surgical mesh and so FDA has provided a guide in the use of these meshes.

The following is a summary of FDA’s recommendations regarding the use of surgical mesh implants

Recommendations for the surgeons: TheFDA gives a separate set of recommendations each for the surgeon and the patient. Following things are to be taken care of by the surgical end of the matter.

1.The surgeon should realize that most forms of pelvic organ prolapse can be treated conservatively or by simple repair without the need of a mesh. Therefore unnecessary usage of the transvaginal mesh should be minimized.

2. The mesh placement is a permanent approach, and once it has been placed it might be difficult to operate on the same patient in the future for any other problem. This is owing to the altered anatomy of the patient’s internal structures as a result of mesh implantation. It will predispose the women to greater risks in the future surgeries.

3.The risk of complications is higher with transvaginal placement of the mesh than the abdominal approach. Therefore an abdominal surgery should be opted in most cases, when there is no contraindication to it.

4.It is the surgeon’s responsibility that all the pros and cons should be told to the patient before the surgery. A complete informed consent should be sought before proceeding to the surgery.

Recommendations for the patients: The following is a set of guidelines is to be followed religiously by the patients in order to decrease the chances of complications.

1.It is mandatory for the patient to ask the surgeon everything about the mesh surgery. The patient needs to understand as to why the surgeon is opting for a mesh and what could go wrong if a non-mesh procedure is employed.

2.The women have to continue with the regular post operative routine check-ups. It is also mandatory to notify to the surgeon any kind of complications developing; e.g. continuous vaginal bleeding, heavy vaginal discharge, pain in the legs and lower abdomen, persistent fever and painful intercourse. This will allow for the prompt start of treatment of these issues.

3. Those patients who have had a pelvic organ prolapse surgery, but do not know if a mesh has been placed or not, should try to find this out on their next scheduled visit. This is important as it will help the patient recognize the possible side effects that can develop after the surgery and will aid in the early detection of these complications.

If you or a family member experience serious or embarrassing complications after surgery for vaginal Hernia, Pelvic Organ Prolapse or Stress Urinary Incontinence, complete our patient intake form, and an expert and compassionate female case manger will contact you today!

The author is the webmaster for TheLawsuitNewsReport.com, Expert Legal Resources. For the People, by the People”

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