FDA slow to take action on vaginal mesh

UPDATE: 24 January 2012

Dems call for Lap-Band, mesh probes ahead of MDUFMA re-authorization

Democrats in the U.S. House of Representatives are calling for a congressional probe into a pair of high-profile medical device products – Lap-Bands and vaginal mesh – as Congress gears up for hearings and a vote on re-authorizing the Medical Device User Fee & Modernization Act.

Democrats in the U.S. House, concerned about a pair of high-profile medical devices, want the Energy & Commerce Committee to open a probe into gastric band and vaginal mesh products. SOURCE

US House of Representatives recently has been visiting my series of articles on surgical mesh.  Find them all using our search window.

5 January 2012

FDA wants new studies on surgical mesh

By Anna Yukhananov,  Thu Jan 5, 2012

WASHINGTON (Reuters) - U.S. health regulators ordered new safety studies for surgical mesh implants that are used to hold pelvic organs in place, citing a spike in the number of complications seen for female patients, including erosion and infection.The Food and Drug Administration also said it may reclassify the devices in a higher-risk category that would require manufacturers, such as Boston Scientific and a unit of Johnson & Johnson, to conduct clinical trials in people before receiving approval for sale.
The companies could not be immediately reached for comment.
The devices, made of synthetic or biological material, are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP). They are also used to help those with a severe overactive bladder known as stress urinary incontinence.
The FDA said it received more than 1,500 reports of complications related to the repairs with mesh from 2008 to 2010, including cases in which the mesh eroded into the vagina or caused bleeding and infection. The rate of problems was five times the rate reported from 2005 to 2007.
The FDA sent letters this week to 35 manufacturers of transvaginal surgical mesh, requesting three-year studies of several hundred women each to study side effects, as well as the women's overall quality of life.
In July, the agency warned that complications with the mesh were "not rare" and that transvaginal organ repair using mesh may put patients at greater risk than other surgeries and treatments.
The FDA also said it was concerned about scientific studies that show a lack of clinical benefit from surgical mesh, compared to non-mesh repair.
About 75,000 women received mesh repairs for pelvic organ prolapse in 2010 and about 200,000 women received transvaginal repairs for stress urinary incontinence.
The agency is asking for more studies from companies that sell the mesh for POP surgery. In the case of mesh used to correct an overactive bladder, the FDA is seeking further study of use of a so-called "mini-sling," when strips of material are used around the bladder neck and the urethra.
During their lifetime, 30 percent to 50 percent of women may experience POP, with two percent developing symptoms. The condition happens when tissue that holds the pelvic organs in place becomes weak or stretched and bulges into the vagina.
Surgery to support prolapsing organs can be done through the abdomen or the vagina, either with stitches or also with surgical mesh for reinforcement.
Surgical mesh has been used since the 1950s to repair abdominal hernias, but doctors only started using the mesh for POP and stress urinary incontinence in the 1990s, a procedure that has grown in popularity.
Companies that wanted to make the mesh specifically for POP or urinary incontinence could submit their application under a 510(k) accelerated review application that did not require them to do clinical trials in people, as long as they could show their implants were similar to devices already on the market.
But during a panel meeting in September, outside advisers to the FDA recommended that the agency reclassify the devices for POP to require companies to submit additional studies. The FDA said it is considering their advice.
Jeffrey Grand, a lawyer at Bernstein Liebhard in New York, is representing women who are suing companies that make the transvaginal mesh, with a case going to trial later this year.
"These things were basically put on the market without any significant safety testing," Grand said. "I'm hoping that all of this brings about some regulatory changes."

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In September 2011 the FDA convened a conference on the use of TV mesh and the consideration for changing its device classification to a more stringent one.

Now the FDA is calling for comments regarding its process of classifying its own process.  You can read more about this here... 



FDA Public Health Notification: Official 2008 warning from the FDA

Serious Complications Associated with Placement of Surgical Mesh 

in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence 

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

READ MORE: TRANSVAGINAL MESH AND WOMEN'S HEALTH

What to consider before choosing surgery -

Alternatives to the laparoscopic Burch and/or paravaginal repair procedures include the following:

• do nothing and continue to experience the loss of urine
• medical (non-surgical) treatment
• lifestyle modification: quit smoking, lose weight, allergy treatment
• Kegel’s exercise: regular contraction of the muscles that allow you to stop urine in mid-stream may reduce or eliminate incontinence
• pessary use: usually a donut-shaped rubber or plastic device inserted into the vagina to support the bladder
• hormonal (estrogen) replacement therapy
• treatment with medication helps certain types of incontinence
• other surgical procedures including
  • the so-called anterior repair (performed from a vaginal approach),
  • other procedures performed in the space between the bladder and pubic bone (may be done at laparoscopy or through a large incision at laparotomy),
  • sling procedures usually done with an incision in the vagina and a 1-2" incision at the pubic hairline,
  • collagen injection (injection of a natural glue-like substance into the bladder neck), and
  • InterStim® - a nerve stimulator is surgically placed to reduce bladder irritability

Many times using a combination of several forms of treatment results in the best treatment for incontinence and paravaginal defects (such as losing weight, stopping smoking, taking estrogen replacement, performing Kegel’s exercise, and having the Burch procedure). If you have any questions regarding the above or any aspect of the proposed surgery, be sure to discuss them with your physician. SOURCE


Request our prevention article


Read more -
http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html

http://naturalhealthnews.blogspot.com/p/womens-health-transvaginal-mesh.html

How FDA Approved Mesh 

Graphic Courtesy of Patrick

Latest News on Device Approval from Congress, 13 December, 2011

Misleading Data on Breast Implant-Related Cancer Removed from Site

Toxic Breast Implants

French Warned of Toxic Implants, no one listened

More than 30,000 women have had breast implants filled with industrial silicone instead of medical-grade fillers.  Complete article.

Thousands Of Women Given Leaky, Toxic Breast Implants Complete article.

Breast Implants and Rupture Science is still debating as to whether ruptured silicone breast implants are responsible for illness and disease. What is known is that when the silicone leaches throughout the body, it wants to stay in the body. Any foreign matter, including silicone, is not easily transported out of the body. The body needs help in ridding itself of any potentially harmful agent.
DNR, Inc. has created Body Soak-Gold for those women who have experienced ruptured silicone implants. Its design is to help activate the body's own resources necessary for it to release and remove impurities resulting from leaching or ruptured implants. This can occur with each soak and for hours thereafter.
Light Energized SolutionsBody Soak GOLD Item #: 105-G
Your Price: $52.00
Stress - Cleansing - Breast Implants - Relaxing - Emotions

Posted Feb 2011

Another attempt by mainstream medicine to keep women uninformed about health risks has been stymied.

In February 2011, Public Citizen alerted the FDA that the presidents of two leading plastic surgery organizations – the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) – urged members to inaccurately downplay the significance of recent evidence about the risks of breast implant-related cancer when speaking to female patients during a recent members-only webinar posted on the ASPS and ASAPS websites. Such communications represented a deplorable attempt to trivialize the significance of the findings of increased numbers of cases of a rare form of cancer, called anaplastic large cell lymphoma (ALCL), in women with breast implants. Public Citizen called on the FDA to stop this deliberately misleading messaging campaign, the goal of which apparently was to keep women in the dark about the dangers of breast implants so they will continue to ask for them. Complete article

New Leadership:  Karuna R. Jaggar appointed Executive Director of Breast Cancer Action.

San Francisco, CA— After an exhaustive search the Breast Cancer Action board of directors announced Karuna R. Jaggar as the organization’s new executive director.  “We feel extremely proud and excited about our new Executive Director,” said BCA board president Claudia Cappio. “Karuna has worked in non-profit leadership and capacity building for 15 years advocating for women’s rights and socio-economic empowerment.  She uncompromisingly challenges inequities at every level and this will continue to be her focus as she leads Breast Cancer Action.”

Jaggar has a personal passion to end the breast cancer epidemic fueled by her commitment to social justice and her own experiences as a patient advocate.  “My closest family members have grappled with three breast cancer diagnoses during the last ten years,” Jaggar stated.  “It is not enough to educate ourselves and try to make “good” lifestyle choices. We need systemic change to end this breast cancer epidemic.”

Jaggar is driven by the reality that social injustices and environmental factors put each of us at risk of developing breast cancer, regardless of family medical history.  “Every woman affected by breast cancer should possess the power and knowledge to make informed decisions that enable them to take control of their healthcare,” Jaggar said.  “This includes a women’s right to access affordable treatment options, to create individualized treatment plans, and to make healthcare decisions centered on personal values and priorities.”

Under Jaggar’s leadership, BCA will remain uncompromising on issues of health, social and environmental justice:  “We will continue to fearlessly and relentlessly tell the truth about breast cancer,” Jaggar asserted.

Breast Cancer Action, the San Francisco based national watchdog of the breast cancer movement, is known for a commitment to understanding breast cancer through a social justice and health equity lens.  The organization demands greater corporate accountability and better treatment options for patients; pays keen attention to the social inequities that cause differences in breast cancer incidence and outcomes; secures changes at the policy level to reverse involuntary exposure to carcinogens; and works to shift  the balance of power at the FDA away from pharmaceutical companies towards patient interests. 

Prior to her role at BCA, Jaggar was the Executive Director, East Bay of the Women’s Initiative for Self Employment where she worked to reverse inequities among low-income women and women of color.  Jaggar replaces Barbara Brenner who retired at the end of 2010.