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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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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