Study Shows Mirena IUDs Connected to Breast Cancer

Merina IUDA recent study published in the Obstetrics & Gynecology medical journal researched the connection between certain intrauterine devices (IUDs) and a higher risk of breast cancer. This study specifically focused on women who used Mirena, sold by Bayer, and similar IUDs that release a synthetic progestin known as levonorgestrel to prevent pregnancy and treat heavy periods. The small, plastic, T-shaped device is placed in the uterus to partially suppress ovulation and thin the uterine lining to prevent implantation of a fertilized egg.

This study collected data from over 93,000 women between the ages of 30 and 49 who used Mirena or other IUDs that release levonorgestrel from 1994 to 2007. All of the patients chose this form of treatment for menorrhagia, a medical term for heavy and prolonged menstrual bleeding.

Of the women in the study, 2,781 patients received breast cancer diagnoses. In the case of breast cancer specifically, there were 1,542 cases, as opposed to the calculated normal incidence rate of approximately 1,292 breast cancer diagnoses. When applied to the population as a whole, this would account for a 20% increased risk of breast cancer for patients using Mirena.

Although breast cancer risk appears to increase while on Mirena, the risk for some other cancers seems to get lower when using these devices. Endometrial adenocarcinoma and pancreatic cancer decreased by 50%, diagnostic rates of lung cancer decreased by 32%, and ovarian cancer rates decreased by 60%.

“Using the levonorgestrel-releasing intrauterine system for treatment of menorrhagia during reproductive years was associated with a lower incidence of endometrial, ovarian, pancreatic, and lung cancers than expected,” stated the research authors. However, they did mention the need for more testing to establish the influence of other factors, such as lifestyle and genetics.

Patient Education Is Key

Any form of medical treatment carries risks. While there are benefits to using IUDs, there are also serious risks, including the 20% increased risk for breast cancer. Mirena has also been reported to include side effects such as spontaneous migration of the device and perforation of the uterus. Patient advocates suggest that more comprehensive patient education initiatives to fully inform patients of the serious risks associated with IUD use would benefit women.

Dr. Angela Marshall, the director of Comprehensive Women’s Health in Silver Spring, Maryland, stated, “We need to educate our patients, because many of these therapies may work, but some could have serious side effects. Women need to be told. Then it’s up to the patient, along with a doctor’s guidance, to make the decision.” Better patient information upfront could allow women to make smarter, well-informed decisions about their health.

Source:

http://injurylawyer-news.com/2014/07/study-connects-breast-cancer-risk-mirena-iud/

FDA Rejects Citizen Petition to Ban Transvaginal Mesh

Regulators at the Food and Drug Administration (FDA) have rejected a petition to ban United States sales of nonabsorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP). The petition was filed in 2011 by the consumer advocacy group Public Citizen.

The FDA issued a letter to Dr. Michael Carome, then deputy director of Public Citizen’s Health Research Group expressing sympathy for the petitioner’s concerns and even some level of agreement. However, the FDA did not agree with the proposed remedies, nor that a total ban and recall was necessary.

While the FDA acknowledged worries that transvaginal mesh products pose safety risks to women, it stated that it was already taking steps to counter those concerns. According to the FDA in its response, “There is not sufficient evidence at this time to support a finding that there is a reasonable probability that all nonabsorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP would cause serious, adverse health consequences or death.”

The Future of Pelvic Mesh Products

While the outright ban of nonabsorbable pelvic mesh products is not going to happen, there will be changes in the way the FDA treats these devices in the future. The FDA issued a tentative reclassification order to upgrade transvaginal mesh products to Class III. This would require premarket approval for all related devices.

Furthermore, the FDA has made safety communications about the risks posed by transvaginal mesh required before use and has increased post-market scrutiny. The FDA even stated that there was some evidence that there were measurable benefits to using surgical mesh when transvaginally repairing pelvic organ prolapse.

These actions have not totally placated concerns by consumer organizations who are worried about the side effects of transvaginal mesh, including vaginal scarring, shrinkage, and pelvic pain.

Public Citizen has stated that actions taken by the FDA are “backward” in the case of this product. Furthermore, they believe that while the higher regulatory scrutiny will be good for consumers, the FDA is undercutting its effectiveness in two ways. First, they believe that the FDA’s allowance of 510(k) clearance for transvaginal mesh products goes against purposes of the intensive premarket approval process. Secondly, they worry that the length of time for the installment of the reclassification will hurt women in the meantime.

Despite this fact, many organizations view these actions by the FDA as a step in the right direction. With added oversight, there is hope that the true health risks and benefits of transvaginal mesh can be known.

This response by the FDA does not preclude it from issuing a recall later. Many manufacturers of transvaginal mesh have been sued by patients who have been treated with nonabsorbable pelvic mesh, and researches on the products are still being conducted.

In the end, the FDA has a responsibility to take any accusations of patient risk seriously, so this is not the end of investigations regarding transvaginal mesh products.

Source:

http://www.fiercemedicaldevices.com/story/fda-rejects-petition-ban-transvaginal-mesh/2014-07-16

Surgical Mesh Kits – Tighter Regulations

The University of Utah in 2009 published a study conducted by the National Institute of Health and the Pelvic Floor Disorders Network that indicated as many as 1 in 9 women go through pelvic prolapse surgery each year. This surgery, already risky to a woman’s future pelvic health, can be further complicated if the surgical mesh kit being utilized fails to meet common safety standards established by the FDA. While most surgical mesh kits, commonly those used in operations for urinary incontinence, meet the established guidelines, others used in the more delicate procedure for pelvic prolapse fail to perform as expected. Women who are outfitted with these poorly designed kits are at risk of developing further complications, such as displaced mesh and significant levels of pain that can only be relieved by more surgery.

In fact, with the 510 (k) clearance process, the kits used for both types of pelvic operations are typically expedited through the review and inspection procedure. This procedure is designed to get the products to the market immediately so that patients can get the medical help they need right away. However, while this expedited review does not seem to affect the kits used for incontinence, it does adversely affect those that are needed for prolapse surgery. The FDA now stipulates that the prolapse mesh kits must be inspected more thoroughly to help patients avoid complications from their procedures.

The primary inspection of the prolapse mesh kits should help regulators ensure that the mesh is shaped properly for pelvic prolapse repair. Both kits until now feature mesh that was shaped the same. While the shape appeared to work well for urinary incontinence, it failed to work as expected in prolapse repair operations. Women outfitted with this poorly shaped mesh were found to suffer from complications like the mesh slipping out of place to perforations that caused excruciating pain. In fact, so many women suffered complications that the Huffington Post now reports that “thousands” of lawsuits against surgical mesh kit manufacturers have been filed, with one woman in California recently being awarded more than $5 million in damages by a state court.

With the FDA mandates, however, these lawsuits could come with less frequency as patients receive better care and suffer fewer post-surgical side effects. Major manufacturers, including Johnson & Johnson, report that their kits already meet the new safety guidelines and are ready for use today. These new mandates and continuing FDA monitoring could be vital to women who want to avoid the life-changing consequences experienced by other patients in the past.

Blood Glucose Test Strips Warning – False Results

The American Diabetes Association reports on its website that 1.9 people each year are diagnosed with diabetes. These new diabetic patients join more than 25.8 million people living with this condition, as well as 79 million people who are pre-diabetic or at risk of developing this disease later in life. Most of these patients rely on medical equipment like blood glucose machines to test their blood each morning and help them determine how much insulin they should take each day. Because they rely on these machines, they likewise expect the components of their glucose meters to function as expected. However, the FDA recently issued a warning that people who rely on glucose strips made by Shasta Industries should stop using this brand of strips immediately.

The FDA has found several quality infractions that raise doubts about the strips’ effectiveness and performance. Government inspectors suspect that people who use these components could get false or inaccurate readings, leading them to miscalculate how much medication to take to maintain their diabetic conditions. Rather than rely on strips that could be poorly made or ineffective altogether, patients who use GenStrip glucose strips made for LifeScan OneTouch meters should ask their pharmacist or doctor for a new brand or a new meter that uses a different manufacturer’s components.

This ban also applies to healthcare professionals who use this brand of strips in their offices. When testing patients for high glucose readings, healthcare professionals should use another variety of strips or test for diabetes with a different medical test.

Along with patients and healthcare professionals, pharmacists across the country have been put on high alert for this brand of strips. When patients are given scripts for GenStrip supplies, pharmacists should heed the FDA warning and alert the patient, as well as the prescribing doctor immediately. The ban is in effect until further notice from the FDA. Until then, patients, as well as physicians and pharmacists, should utilize other brands of strips. This precaution can protect people from false readings and perhaps taking too much or too little of the diabetic medication on which they rely. People who take the wrong dosage of glucose could lapse into a diabetic coma or die from a result of an inaccurate reading.

Source:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395270.htm

Jury Decides On Pelvic Mesh Case in Texas

Over recent years, a number of medical solutions to the problem of vaginal prolapse and urinary incontinence problems after pregnancy have offered women increased function and better quality of life. Transvaginal mesh seemed to provide a good option for these problems. However, reports of problems with the device led to a number of product defect lawsuits. In one of these suits, a Texas jury ordered Johnson & Johnson, who manufactures the Ethicon TVT-0 mesh device to pay $1.2 million in damages to a patient who was injured by the device.

Transvaginal Mesh Products

Transvaginal mesh devices were designed to provide additional support for reproductive and urinary organs that may have suffered relaxation from pregnancy or natural aging. The devices are made of natural or synthetic materials, and were designed to be implanted within the vaginal walls to simulate the support of normal muscles. However, women and their physicians reported a number of problems with the device, which in some cases shrank and deteriorated, causing injuries to internal organs. In many cases, additional medical procedures were required to repair the damage to tissues. As many as 70,000 devices were implanted in women just in 2010. An estimated 12,000 federal lawsuits are pending against J & J concerning these devices.

Injuries from the Device

Shrinking, deterioration, and erosion of the device can cause a number of injuries to the patient, including chronic pain, blood in the urine, pain during intercourse, urinary tract infections, fistulas, painful urination, bowel perforation, bladder perforation, and hemorrhage. Many women who had the mesh implanted had to undergo revision surgery to repair the damage caused by the devices. Johnson & Johnson, C. Bard and 31 other companies have been named in lawsuits involving injuries from their transvaginal mesh products.

Sources:
http://www.nj.com/business/index.ssf/2014/04/post_285.html
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm