Understanding The Dangers Of Transvaginal Mesh

Trans-vaginal mesh is an implant of a mesh-like material that is implanted through the vagina. This mesh was originally developed to treat abdominal hernias. However, the mesh was found to be useful for women who were suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both of these conditions can occur after a hysterectomy, childbirth, or menopause due to weakened pelvic muscles. The prolapse occurs when the main organs in the pelvis – the uterus, bladder, and rectum – actually drop down into the vagina.

Mesh repair became more popular, and kits were developed with prepackaged mesh, special tools, and instructions to help doctors with the implantation. By the year 2010, more than 75,000 patients received a trans-vaginal mesh implant. However, of those patients, more than 10% experienced a failed surgery.

There were incidences where the surgery did not solve the problem. The biggest problem women faced, however, was trans-vaginal mesh erosion. This occurs when there is an erosion of the mesh or it passes through the vaginal wall. There is a great deal of pain when this happens, not to mention the bleeding, infection, and nerve damage. Once the mesh erodes through the wall of the vagina, other organs are affected and damaged as well. Other complications that can occur include recurrence of prolapse or incontinence, neuro-muscular problems, vaginal scarring and shrinkage, painful sexual intercourse, and emotional problems.

Many women have opted to have the mesh removed. However, severe complications often occur. When the mesh is implanted, it is never intended to be removed. Blood vessels and tissues grow around the mesh, forcing doctors to remove the mesh in pieces, each removal requiring a surgical procedure.

In September of 2011, the FDA organized a panel to look into the implants. They found evidence to believe that the implants caused serious problems and they did not significantly improve the POP. However, the committee did not remove the device from the market, but instead called for more testing. The FDA finally ruled that manufacturers must conduct a three-year study on their mesh products.

Sources:
http://www.drugdangers.com/transvaginal-mesh/
http://www.drugwatch.com/transvaginal-mesh/

Injury And Even Death: Problems With Robotic Surgery

The medical field has seen many advances over recent years that have served to improve health and lengthen lifespan. Robotic surgery uses high-tech equipment that can pinpoint precise areas of the body for tissue removal or repair. However, technology can also bring increased risk of injury or death if the equipment fails or the operator is careless.

About Robotic Surgery

Robotic surgery uses a computer to remotely operate tiny instruments that perform the surgical procedure. Essentially, robotic surgery works by matching the physician’s hand movements after the instruments are inserted into the body. A very small camera, attached to a thin tube (called an endoscope), allows the physician to see the area being treated. Robotic surgery allows the physician to make smaller incisions than would otherwise be possible. This less-invasive surgery generally allows for faster recovery times. However, robotic surgery generally takes longer than traditional surgery and is not available at all hospitals.

Problems with Robotic Surgery

As with other new technologies, physicians require intensive training on the equipment before it can be used properly. Additionally, technical malfunctions can occur that require surgeons to abandon robotic techniques and resume traditional methods. The robotic equipment has also been associated with perforation of adjacent organs, objects being left in the incision site and increased risk of complications after surgery.

Other problems include increased scarring and tissue burns, which have been responsible for at least 5 deaths. Because the equipment is now heavily marketed to surgeons, as well as to their patients, concerns about adequate skill levels and proper equipment maintenance are coming to the forefront of the medical community. Robot-related surgical mistakes have entered the news, and the safety concerns are deepening. The U.S. Food and Drug Administration is taking a fresh look at robotic surgery, training methods for the equipment, and related issues.

DaVinci Robotic Surgery

One of the most intensely marketed robotic systems is the DaVinci robotic system. This technology is being touted for prostate surgeries, hysterectomies, urinary system surgeries and other procedures because of the minimally invasive technique and fast recovery time. However, a number of injuries are being associated with the use of the equipment, including burns to internal organs, punctured blood vessels, bladder tears, severed ureters and problems with incontinence or impotence after surgery. Subsequent surgery to repair organs may also be necessary.

Sources:
http://www.bloomberg.com/news/2013-10-08/robot-surgery-damaging-patients-rises-with-marketing.html
http://www.usatoday.com/story/news/nation/2013/04/09/robot-surgery-fda/2067629/

Alleged Vaginal-Mesh Implants Erosion Costs Endo Health Solutions (ENDP) Millions in Settlement Payouts

Settlement has been reached in many vaginal mesh implant cases. American Medical Systems, Inc. (AMS), a division of Endo Health Solutions, Inc., will pay in excess of $54 million to settle some of these cases.

More than 5,400 cases have been filed against this company regarding alleged defects in the implants. Most of the cases filed against AMS and other companies have not been settled. AMS is one of the leading manufacturers of vaginal implants.

The Use of Vaginal Mesh Implants (VMI)

Vaginal mesh implants were designed as a solution for pelvic organ prolapse and female urinary incontinence. When vaginal walls are weakened or stretched, pelvic organs, including the bladder and uterus, expand and obstruct the vaginal wall. In addition, urinary leaking can occur in some patients.

The implants are manufactured with synthetic or natural materials to strengthen the damaged muscle tissue. Normally, they are implanted permanently into the pelvis in the area of the damaged tissue.

The Food and Drug Administration (FDA) first approved vaginal mesh implants in the late 1990s. Since that time, the FDA has approved more than 100 different products for use by more than 40 different companies. Approximately 500,000 VMI operations are performed annually in the United States.

FDA Warning Regarding Vaginal Mesh Implants

In 2008, the FDA reported side effects and complications involving the implants. Many of the defects included wearing away or shrinking of the mesh material. This has led to additional operations to repair the mesh, pain exhibited by women undergoing the procedure, and pain during urination or sexual intercourse. In some cases, injuries have been more severe.

On July 13, 2011, the FDA updated its warning regarding the use of vaginal mesh implants. Though it had previously reported that complications involving the implants were rare, additional evidence received from 2008 to 2010 indicated that complications were more common than once believed.

Rise in Vaginal Mesh Implant Litigation

More than 5,000 lawsuits have been filed against AMS alone for claims of injury due to alleged defective mesh products. The AMS cases have been consolidated in the Southern District of the U.S. District Court in West Virginia. The settlement recently announced is not a global settlement.

It is estimated that more than 28,000 total lawsuits have been filed, including several where jury verdicts exceeded several million dollars. In the past few months, more than 1,000 new lawsuits were filed. The rise in recent filings is believed to be related to the statute of limitations and is tied to the FDA announcement on July 13, 2011. In most states, an injured party has two years to file a lawsuit. The two-year period often begins when the product is first used or when it is first known to cause injury. The FDA announcement two years ago would likely be considered evidence of knowledge of the implant’s defective nature.

Sources:

http://www.drugwatch.com/transvaginal-mesh/brands/
http://www.bloomberg.com/news/2013-06-21/endo-health-unit-pays-55-million-in-vaginal-mesh-accord.html
http://www.fda.gov/MedicalDevices/Safety/alertsandNotices/ucm262435.htm

FDA Rules that Metal-on-Metal Hip Replacements Create Problems

For many patients, a hip replacement is the best option for a healthy future. Options for hip replacement devices include metal-on-plastic, metal-on-polyethylene, metal-on-metal, and metal-on-ceramic. Until recently, about 1/3 of all patients receiving a hip replacement have been receiving an all-metal device.

While all hip replacement devices carry risks, the FDA has found that metal-on-metal devices have additional unique risks. The metal parts rub against each other as a patient moves, creating friction between the metal parts which allows tiny particles to enter into the body’s bloodstream; which causes inflammation, allergic reactions, and pain. It is estimated that 1 in 1,000 patients have exhibited sensitivity to these metals (e.g. cobalt and chromium).

Reports found that metal hip replacement parts are also failing earlier than those that are made of other materials such as plastics, ceramics, or a mix of metal and plastic. If metal hip replacement parts fail early, a need for revision surgery to correct the problem may be necessary.

Metal-on-metal hip parts have been the subject of criticism for several years. In 2010, DePuy recalled their all-metal hip replacement device, the Articular Surface Replacement (A.S.R.). There have been several international studies warning against the use of metal on metal hip replacement parts. DePuy is facing over 13,000 lawsuits related to all metal replacement hips in two models, the ASR and the Pinnacle.

The FDA has not ruled that companies cannot manufacture the all-metal hip replacement devices but the agency is requiring companies to conduct intensive studies with patients in order to sell the devices. DePuy has decided not to conduct these studies and instead, it will discontinue selling all metal hip replacement parts. The company will also stop selling metal parts that are used in Pinnacle and Complete systems which combine ceramic and metal components.

Metal-on-metal replacement hips once accounted for one in three hip implants used in the United States. However, more recently few doctors are choosing to replace their patients’ hips with metal-on-metal devices.

The following symptoms may indicate that the hip replacement device is not working correctly:

  • pain in groin, leg, or hip
  • swelling in area of hip joint
  • limp or other change in walking ability
  • sounds such as popping, grinding, clicking, or squeaking

Recommended Reading:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm

http://healthletter.mayoclinic.com/editorial/editorial.cfm/i/262/t/
Choosing%20the%20right%20total%20hip%20replacement/

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm

Insulin Infusion Pump from Animas Recalled Due to False Alarm

There has been a Class I Recall on the Animas 2020 Insulin Infusion Pump. These machines are manufactured to pump insulin directly into a person’s bloodstream. They are used by people who have insulin issues related to a diagnosis of diabetes. This recall was listed during the first week of April and was issued by the Food and Drug Administration (FDA).

Insulin infusion pumpThe pumps manufactured from March 1 to November 30 of last year (2012) are the ones that have their functionality in question. According to FDA safety information, a component of the machine could possibly sound a false alarm. The alarm may be falsely alerting the user to problems concerning “loss of prime,” “occlusion” or “no cartridge detected.”

If one of these alarms sounds, the user might be instructed to “rewind, reload and prime” the unit. Caution is necessary when performing these steps because if you do not first unhook the pump from the body, it could cause extra insulin to be deposited into the bloodstream. This could cause serious injury, or even death, because of illnesses, such as hypoglycemia, that may occur.

There is also a flaw in the software system of this product. The machine will only work until December 31, 2015. After that date, it will stop pumping insulin and make a “Call Service Alarm.” The company, Animas, is offering advice as well as recommendations to people using this pump.

The company states that if a person has this machine that they should call the Product Fulfillment Center. They are open from 6 a.m. until midnight to be accessible to those customers dealing with problems relating to this recall. The company will send out a free replacement for the faulty pump.

Also, the company wishes that any patient with side effects relating to this issue report those problems. You can report these problems with an online report from the FDA, or clients may download or request forms by mail. Anyone with questions or concerns of any variety is encouraged to call the Fulfillment Center or Technical Support Center.

Related Sources:
http://www.ivteam.com/animas-corporation-2020-insulin-infusion-pump-class-i-recall-false-alarm-or-warning-sound/
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346788.htm