Recently in Defective Medical Devices Category

FDA Wants Transvaginal Mesh Device Makers to Study Related Health Complications

January 11, 2012,

At Howard Law, PC, our Orange County, California products liability represent patients that have been injured because of medical devices that were defective, failed, or faulty. One device, in particular, that has spurred hundreds of personal injury lawsuits in the US over the past few years is vaginal mesh, which has been used in hundreds of thousands procedures over the last few years as the implant device of choice for women suffering from pelvic organ prolapse and stress urinary incontinence.

Now, the Food and Drug Administration has written to 33 transvaginal mesh manufacturers telling them that they need to study the rates of health complications linked to these medical devices for a three-year duration. Johnson & Johnson, Boston Scientific, and C.R. Bard Inc. are three of the companies that received these letters, which come several months after the federal agency reported a significant jump in the number of injuries, deaths, and failures related to the mesh implants. The FDA also noted that it cannot verify whether using transvaginal mesh, as opposed to more traditional devices and procedures to treat the same ailments, presented more benefits.

Many of the women who reported related complications have had to undergo additional surgeries to remedy the damage done and/or remove the implant. In some cases, scar tissue that had developed made it impossible to remove the faulty device. Some patients have had to deal with chronic pain, organ damage, infection, urinary tract erosion, organ perforation, perineal cellulitis, painful intercourse, and other complications as a result of their vaginal mesh implants.

"It is important that medical devices are free from safety issues that can cause serious injury to patients," said Howard Law PC partner and Anaheim transvaginal mesh attorney Vincent Howard. "The number of injuries linked to mesh implants is unreasonably high and unacceptable."

The FDA received reports of 1503 adverse occurrences related to transvaginal mesh between 2008 and 2010. This was a fivefold increase from the two years prior.

"You want to work with an Orange County, California medical device manufacturer that isn't afraid to go up against large companies so that you can recover the compensation that you are owed," said Anaheim products liability attorney Vincent Howard.

Vaginal mesh products are FDA-approved under the 510(k) system, which allows medical devices that are similar to ones already approved to forego human testing. However, it is important to note that the majority of transvaginal mesh products that are FDA-approved under this system can trace their approvals to a mesh product made by Boston Scientific that was recalled 13 years ago.

The studies the FDA wants the 33 manufacturers to conduct will focus only on mesh products already available in the marketplace. One wonders why transvaginal mesh products that are not yet available shouldn't be studied before they are released into the market.


J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says, Bloomberg, January 5, 2012

FDA reevaluating vaginal mesh implants, Los Angeles Times, July 13, 2011


More Blog Posts:
Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers, July 13, 2011

Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers, July 5, 2011

California Products Liability: Defective Hip Implant Devices Continue Causing Injuries, California Injury Lawyers Blog, December 30, 2011

Continue reading "FDA Wants Transvaginal Mesh Device Makers to Study Related Health Complications " »

California Products Liability: Defective Hip Implant Devices Continue Causing Injuries

December 30, 2011,

As our Orange County, California defective medical device law firm mentioned in a previous blog post, Howard Law, PC, represent clients in Southern California that were been injured or have had to undergo revision surgery because the hip implant device that they were given proved faulty. Already, over 5,000 products liability lawsuits have been submitted the US by patients seeking to recover compensation. Most of the cases involve DePuy hip implant devices from Johnson & Johnson that were recalled last year. DePuy is also being sued over its line of Pinnacle hip implants.

However, as evidenced by a recent US Food and Drug Administration-commissioned study, Johnson & Johnson is not the only manufacturer making faulty hip implants. The study examined the outcomes of 830,000 hip implant procedures. 18 other studies involving more than 3,000 patients were also evaluated.

Per the FDA commissioned-study, the newer ceramic-on-ceramic and metal-on-metal implants don't exhibit a lot more benefits than their older counterparts, which are made of metal-on-polyethylene and ceramic-on-polyethylene. Patients implanted with devices made of all-metal seem also seemed more like to undergo revision surgery to have an implant replaced.

"Getting a hip implant is a stressful surgical procedure to begin with," said Howard Law, PC partner and Anaheim defective medical device attorney Vincent Howard. "For a patient to have to undergo a second surgery because an implant failed or proved toxic is unacceptable."

In addition to earlier than acceptable failure rates, there are concerns that some of the defective devices are shedding metal debris inside their recipients. The debris is dangerous because after the combined with the scavenger cells released by the body to neutralize them, the human tissue and muscle can become damaged, potentially to crippling effect.

It wasn't too long ago that the FDA sent out notices to the makers of all-metal hip devices telling them to conduct studies to figure out whether their products were shedding toxic levels of metals. Stryker, Biomet, Zimmer, Wright Medical, and DePuy are among the companies that receive this notice.

Per medical and legal experts, hip failures could end up costing billions of dollars. Tens of thousands of people in this country alone may have to undergo revision surgery in the next decade.

"Considering that many of the patients who undergo hip implant procedures are elderly seniors, the trauma of not just one replacement surgery but two can take their physical and emotional toll," said Orange County, California defective hip implant device lawyer Vincent Howard.

Metal-on-Metal Hip Implants Offer No Advantages over Older Versions, FDA Study Finds, News Inferno, November 30, 2011

The High Cost of Failing Artificial Hips, New York Times, December 27, 2011

More Blog Posts:
California Products Liability?: FDA Warns that Lap-Band Ads are Misleading, California Injury Lawyers Blog, December 14, 2011

Transvaginal Mesh Lawsuits Raise Questions About FDA's Medical Device Review Process, California Injury Lawyers Blog, October 20, 2011

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems, California Injury Lawyers Blog, August 22, 2011

Continue reading "California Products Liability: Defective Hip Implant Devices Continue Causing Injuries" »

California Products Liability?: FDA Warns that Lap-Band Ads are Misleading

December 14, 2011,

The Food and Drug Administration has issued a warning to the marketing firm 1-800-GET-THIN and eight surgical centers that advertisements for the Lap-Band are misleading. The surgical device is used to treat obesity by limiting how much food a person can eat. Lap-Band is made by Allergan, which is based in Irvine.

According to the FDA, the 1-800-GET-THIN ads don't include mandatory information about all the possible side effects and risks that can come with using the Lap-Band. Certain precautions, contraindications, and other warnings are also not provided. The federal agency is worried that on the ad inserts, the font size of the information that talks about the risks is not big enough that consumers will see it.


Products Liability

Improper marketing that results in someone sustaining serious injury can be grounds for an Orange County, California products liability lawsuit. Examples of marketing defects:

• Failure to warn of dangers, risks, or side effects
• Inadequate warning
• Improper labeling
• Marketing to the wrong group (For example, promoting a product to kids when it should only be used by adults.)

1-800-GET-THIN LLC offers information sessions and consultations about Lap-Band surgeries. Of the surgical centers that received the FDA warning, a number of them are in Los Angeles County: Beverly Hills Surgery Center, Valley Surgical Center, Palmdale Ambulatory Center, Cosmopolitan Plastic & Reconstructive Surgery, and Cosmopolitan Plastic & Reconstructive Surgery.

The FDA says that unless the ads are revised to address its concerns, the government agency may seize the Lap-Band or impose fines. The companies that received the FDA warning have 15 business days to present their plans for how they intend to change the ads.

"It is irresponsible to incorrectly market any product by failing to warn about the risks involved," said Howard Law, PC partner and Anaheim products liability attorney Vincent Howard. "You may be able to hold the responsible parties liable for the harm you or your loved one suffered."

Lap-Band Surgery
Considered by some to be a safer alternative to gastric bypass, Lap-Band surgery is a surgical alternative to weight loss that can be used for medical reasons or cosmetic purposes. The procedure involves using the band to section the stomach into parts. This allows food to go to the smaller sectioned off area, which will limit how much the person can take in. This usually leads to substantial weight loss. Unfortunately, injuries and deaths have occurred, and plaintiffs have come forward to file Orange County, California medical malpractice and wrongful death claims. Howard Law, PC has reported on a few of these cases and injury incidents, which you can read on our California Injury Lawyers Blog.

FDA Targets Gastric Band Weight-Loss Claims, Food and Drug Administration

Feds warn that 1-800-Get-Thin ads mislead, OC Register, December 13, 2011

FDA Warns Centers for Misleading Lap-Band Ads, ABC News/AP, December 13, 2011


More Blog Posts:
Los Angeles County Medical Malpractice Lawsuit Claims Lap-Band Surgery Caused Wife's Wrongful Death, California Injury Lawyers Blog, March 9, 2011

Family of Lawndale Woman to Pursue Los Angeles Surgery Malpractice Action Over Her California Wrongful Death from Lap-Band Surgery, California Injury Lawyers Blog, April 27, 2011

Los Angeles Medical Malpractice?: California Medical Board Investigates Surgeon Following Lawndale Woman's Death After Lap-Band Procedure, California Injury Lawyers Blog, February 4, 2011

Continue reading "California Products Liability?: FDA Warns that Lap-Band Ads are Misleading" »

Transvaginal Mesh Lawsuits Raise Questions About FDA's Medical Device Review Process

October 20, 2011,

With the number of transvaginal mesh lawsuits rising, the effectiveness of the Food and Drug Administration's medical review process has once again come into doubt. Apparently, defective medical lawsuits against Johnson & Johnson involve a vaginal implant that was based on a similar mesh product that was taken off the market for safety reasons more than 10 years ago. That product was called ProteGen, by Boston Scientific Corp. So why then did the FDA keep approving these new mesh products?

Questions about whether the FDA has been doing its job as watchdog started to surface in the wake of the mass recall announced last year by DePuy Orthopaedics, a J & J subsidiary, of its defective hip implant devices. Medtronic's recall of its Sprint Fidelis defibrillators following over allegedly more than a 100 deaths didn't help either.

Please do not hesitate to contact our Anaheim defective medical device lawyers if you believe that you could have a case.

According to National Women's Health Network police director Amy Allina, as reported in Bloomberg.com, the FDA's 510(k) process for approval lets manufacturers obtain product clearance if it cites similarity to a device that had been previously approved. The next device can then be cited to cleared the next one, and so one. Allina says that if the first approved medical device was recalled, the FDA won't then link it back to devices that were approved after even if they were based on the recalled product. The FDA uses the 510(k) process to approve 90% of device applications annually. The vaginal mesh products, artificial hip implants, and the Medtronic defibrillators all made it through the (510)k process.

Just recently, Boston Scientific put out a class 2 recall of its Pinnacle Pelvic Floor Repair Kits over concerns that the mesh product might detach during surgery. The transvaginal mesh product is supposed to help strengthen and stabilize the pelvic floor to treat pelvic organ proplapse.

More than 600 products liability lawsuits have been filed against vaginal mesh makers, including the one filed a couple of weeks ago by one woman against Boston Scientific. She says that because the Pinnacle pelvic mesh that was implanted in her was defective and that she sustained permanent physical injury as a result. She is seeking $1.5 million in compensatory damages for emotional trauma, medical bills, pharmaceutical costs, disability, loss of enjoyment of life, and pain and suffering.

The FDA recently warned that serious complications related to transvaginal mesh used in treating POP rare are not uncommon. Complications may include organ perforation, infection, or bleeding. Removing this medical device once implanted can be a painful and complicated process that may require numerous surgeries while placing the patient at risk of even more health complications.

Johnson & Johnson vaginal mesh lawsuits another blow to the FDA's device review process, Massdevice.com, October 20, 2011

J&J Vaginal Mesh Approved by FDA Based on Similar Device Recalled in 1999, Bloomberg, October 19, 2011



More Blog Posts:

Public Citizen Wants Transvaginal Mesh Recalled by Food and Drug Administration, California Injury Lawyers Blog, August 25, 2011

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems, California Injury Lawyers Blog, August 22, 2011

Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers Blog, July 5, 2011

Continue reading "Transvaginal Mesh Lawsuits Raise Questions About FDA's Medical Device Review Process" »

Public Citizen Wants Transvaginal Mesh Recalled by Food and Drug Administration

August 25, 2011,

Public Citizen, a consumer advocacy group, wants the FDA to recall transvaginal mesh products. The call comes following the federal agency's warning that the medical device may place patients at unnecessary risk of harm without providing sufficient clinical benefit. It was the FDA's second warning about transvaginal mesh. Please contact our Anaheim defective medical device lawyers if you believe that your injuries were caused by transvaginal mesh.

Three years ago, the FDA put out a Public Health Notification and Additional Patient Information on serious complications involving surgical mesh inserted through the vagina for treatment of stress urinary incontinence and pelvic organ prolapse In this latest warning, the FDA wants health care providers and patients to know that serious complications from use of transvaginal mesh are not rare. The federal agency also says that is not certain whether transvaginal POP repair using mesh is a more successful course of treatment than existing non-mesh repair treatments for POP that also pose less risk of complications.

The FDA's review of published scientific literature between 1996 and 2011 also showed that:
• Placing the mesh for POP repair in the abdomen seems to have a lower rate of complication than placing the mesh in the vagina.

• There is a lack of evidence that transvaginal mesh directed at the back wall or the top of the vagina offers greater benefits than surgery without mesh.

• Although surgical repair through the vagina with mesh for tissue weakness between the vagina and bladder provides anatomic benefit than traditional surgery sans mesh does, symptomatic outcomes are not necessarily better.

• Mesh-related complications when used in POP repair are not linked to one particular brand. Mesh contraction and erosion can lead to painful sexual intercourse, the inability to have sex, and serious pelvic pain.

When considering surgical mesh repair to treat POP it is important to know that if there are complications, you may have to undergo additional surgery. Surgical mesh can also put the patient at risk of new complications. Although surgical mesh is a permanent implant, should complications arise, you may have to more surgeries to remove this medical device, which could impair one's quality of life. Other complications linked to mesh include, bleeding, infection, and organ perforation.

It was just last month that our Orange County, California defective medial device lawyers posted a blog about a woman who sued several manufacturers, including American Medical Systems, for Los Angeles products liability. She said the AMS vaginal sling used during her 2009 POP surgery caused her to develop serious complications and injuries. Laura Jones claims that not only did she experience severe pain and develop urinary problems but also she had to undergo several surgeries so the surgical mesh could be taken out.

In 2008, the FDA said that it had received more than 1,000 reports of surgical mesh-related complications involving the treatment of SUI and POP.

Public Citizen wants the FDA to order all mesh makers to recall all their products that are used for transvaginal repair, mandate that new transvaginal mesh devices fall under the Class III device classification, and ban current marketing efforts for current non-absorbable surgical mesh products.

Recall surgical mesh, consumer group says, Star Tribune, August 25, 2011

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, FDA, July 13, 2011

Petition to Ban Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse, Public Citizen


More Blog Posts:

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems, California Injury Lawyers Blog, August 22, 2011

Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers Blog, July 5, 2011

Cancer Patient Who Could Lose Breasts Following Experimental Procedures Sues for Newport Beach Medical Malpractice and California Products Liability, California Injury Lawyers Blog, March 11, 2011

Continue reading "Public Citizen Wants Transvaginal Mesh Recalled by Food and Drug Administration" »

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems

August 22, 2011,

Johnson & Johnson and DePuy Orthopaedics Inc. are now facing more than 2,000 defective medical device lawsuits over the DePuy ASR metal ASR hip systems that were recalled after they experienced a higher failure rate than expected after implant. Many DePuy hip replacement patients have reportedly experienced joint dislocation, swelling, pain, and, in some cases, systemic damage to the thyroid, central nervous system, or heart. Many users have also had to undergo second hip replacement surgeries because their DePuy medical device failed.

It was last year that DePuy Orthopaedics and Johnson & Johnson recalled about the ASR Hip Resurfacing Systems and the ASR XL Acetabular Hip Replacement devices (that's about 93,000 products). The announcement came after the National Joint Registry of England and Wales reported that within five years of implant, one in eight patients underwent revision surgery to replace the device. There is also concern that toxic metals from the recalled DePuy hip system are showing up in some patients' blood. If you or someone you love has experienced any of the complications mentioned above after being implanted with a DePuy hip replacement device, do not hesitate to contact our Anaheim defective medical device law firm immediately.

With so many people filing their products liability complaints against J & J, there is no doubt that the manufacturer is concerned about liability costs. Legal experts are saying that as a result, DePuy has retained the services of Broadspire Services Inc., a third party, to pay claims for out-of-pocket medical expenses related to the recall. Some believe that this is J & J's way to limit payments while obtaining medical records and other material that could be used in court.

While recalls are usually directly dealt with by companies and their lawyers, who often will go with a doctor's recommendation on whether a medical device should be replaced or removed, with Broadspire in the picture, it would be up to its doctors to decide whether or not to pay for treatment related to the DePuy medical device. There is concern by some that seeing as DePuy is footing the bill for Broadspire to do this job, conflict of interest may be a factor.

Hip replacement surgery is never easy, and many patients tend to be elderly seniors. Not only is hip replacement a painful procedure, but also recovery, as well as learning to walk with the new implanted device, can take time. In addition, having to undergo another surgery again can take a toll, and there is always risk of health complications and infection when any type of invasive procedure is involved. Contact our Orange County, California DePuy Hip Replacement law firm to request your free case evaluation.

Insight: DePuy's handling of hip recall sparks questions, Fox Business/Reuters, August 21, 2011

DePuy

Johnson & Johnson

ASR Hip Replacement Recall Guide

National Joint Registry of England and Wales

More Blog Posts:
Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers Blog, July 5, 2011

Cancer Patient Who Could Lose Breasts Following Experimental Procedures Sues for Newport Beach Medical Malpractice and California Products Liability, California Injury Lawyers Blog, March 11, 2011

CT Scans Can Increase Cancer Risk, Says Two New Studies, California Injury Lawyers Blog, December 14, 2009

Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court

July 5, 2011,

Laura Jones is suing American Medical Systems and other unnamed manufacturers for California personal injury. In her defective medical device lawsuit, which she filed in Los Angeles Superior Court, the plaintiff claims that problems with the AMS vaginal sling that was implanted in her during a pelvic organ prolapse surgery in 2009 caused her to sustain serious injuries and health complications.

The vaginal sling was inserted in Jones to help restore normal vaginal structure and support her pelvic organs. However, following the procedure, Jones says she experienced urinary problems and serious pain. She eventually underwent a number of surgeries to have the surgical mesh removed.

In her Los Angeles defective medical device complaint, Jones claims that AMS neglected to warn patients about the potential side effects involved with using its vaginal mesh. She contends that the manufacturer should be held liable for strict liability, breach of implied and express warranty, negligence, misrepresentation, and fraud. She also says that AMS violated California's consumer protection laws.

Jones is not the first person to claim personal injury from a vaginal mesh. In 2008, the US Food and Drug Administration said that 9 surgical mesh makers had sent over 1,000 reports of complications linked to surgical mesh used to repair Stress Urinary Incontinence and Pelvic Organ Prolapse. This year, the New England of Journal Medicine published a study reporting that use of a vaginal mesh is accompanied by the risk of serious complications, such as pelvic hemorrhage and bladder perforation. Other possible effects, which the FDA has since warned about include perforation of the blood vessels, bladder, or bowel during insertion of the device and infection or incontinence if the mesh were to erode while inside the body.

Defective medical devices can cause serious Los Angeles personal injuries and wrongful death. It is important that you are represented by a law firm that knows how to pursue you recovery and is not afraid to go after manufacturers for their negligence and the harm that you or a loved one has suffered.


Related Web Resources:

Checklist of Significant California and Federal Consumer Laws, Ca.gov

New England of Journal Medicine

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, FDA, October 20, 2008

American Medical Systems

More Blog Posts:
Cancer Patient Who Could Lose Breasts Following Experimental Procedures Sues for Newport Beach Medical Malpractice and California Products Liability, California Injury Lawyers Blog, March 11, 2011

Actor Files Los Angeles Personal Injury Lawsuit Over Defibrillator Accident on Burbank Soundstage, California Injury Lawyers Blog, October 28, 2010

CT Scans Can Increase Cancer Risk, Says Two New Studies, California Injury Lawyers Blog, December 14, 2009

Cancer Patient Who Could Lose Breasts Following Experimental Procedures Sues for Newport Beach Medical Malpractice and California Products Liability

March 11, 2011,

A 58-year-old woman whose cancer was treated using the Axxent Electronic Brachytherapy System at Hoag Hospital is now suing for Newport Beach medical malpractice. The patient, referred to as "Jane Doe," may lose one or both of her breasts following the experimental radiation procedure. She is also suing manufacturer Xoft Inc. for California products liability over the allegedly defective medical device.

The woman was treated on June 24, 2010. During her six-month checkup, doctors discovered high-density tungsten particles in the breast that was treated. The tungsten, which is a metal element, allegedly broke off from the XOFT/iCAD Axxent Flexishield Mini, a device used during the procedure that was supposed to protect patient from radiation. Last month, Xoft Inc. recalled the Flexishield Mini, citing that a Jane Doe had reported finding the metal in her body during a follow-up mammogram. The manufacturer, however, said that the discovery didn't mean that the procedure was less safe.

Doctors, however, are recommending that Jane Doe get her breast removed to ensure that the metal particles don't end up spreading to other parts of her body. She might even end up undergoing a double mastectomy so that her breasts appear more natural. Jane Doe is seeking Newport Beach injury compensation for pain and suffering, lost wages, and medical expenses.

Defective Medical Devices Cases
Unfortunately, there are medical devices out there that can cause more harm than good to a patient. The resulting health complications can be traumatic and costly, possibly leaving the patient worse off than before. If you have been injured by a defective medical device, you may have grounds for a California products liability lawsuit against the manufacturer. You also may reason to sue your medical provider for Newport Beach medical malpractice.

Reasons for Filing a Defective Product Claim:
• Manufacturing defect
• Design defect
• Marketing errors, failures, or defects


Hoag patient sues after experimental therapy, Daily Pilot, March 9, 2011

Metal found in patient's breasts, OC Register, March 9, 2011


Related Web Resources:
Xoft Inc.

Axxent Electronic Brachytherapy System

Actor Files Los Angeles Personal Injury Lawsuit Over Defibrillator Accident on Burbank Soundstage

October 28, 2010,

TV actor Brandon Eaton is suing Physio-Control Inc. for Los Angeles personal injury. Eaton was injured when he was accidentally zapped with a real defibrillator while shooting an episode of "Miami Medical" at Warner Brothers studio last year.

Another actor was supposed to use a defibrillator prop on Eaton's chest. Instead, the plaintiff says he was shocked by a medical device, which applied actual electrical charges to his body. Eaton claims that the incident could have killed him.

Eaton was transported to the emergency room. Although he did not sustain permanent physical injuries, he has had to undergo counseling for flashbacks and anxiety. The experience has also made him anxious about being an actor. According to his Los Angeles injury lawyer, Eaton now second guesses the use of props on a set when he goes to work.

Eaton is seeking unspecified damages and medical costs for loss of earning capacity and income from the defibrillator manufacturer, which he claims either knew or should have known that the production company, which ordered the medical device, lacked the experience, training, and knowledge to determine whether or not the device was a prop or real.

Eaton is known for recurring roles on "The Secret Life of the American Teenager" and "Dexter."

Los Angeles Personal Injury
Manufacturers can be held liable for California products liability if a defective or dangerous product caused someone's injuries or deaths. The makers of products have a duty of care to make products that are safe for use. If there are any risks involved, they must provide appropriate warning to users.

'Miami Medical' actor sues for 2009 mishap, Glendale News-Press, October 25, 2010

Dexter Star Sues Show, Claims He Could Have Died, WOOEB, October 6, 2010

CT Scans Can Increase Cancer Risk, Says Two New Studies

December 14, 2009,

Two new studies are reporting that tens of thousands of people might get cancer in the future because they were exposed to radiation when they underwent CT scans. The findings from both studies can be found in the latest edition of the Archives of Internal Medicine. This is disturbing news, considering that more people are opting to undergo this type of imaging technology, once touted as painless, safe, and able to detect diseases. In 2007, 70 million CT scans were performed.

According to one study, led by University of San Francisco researchers, 1 out of 600 men and 1 out of 270 women who undergo CT coronary angiographies when they are 40 will end up getting cancer. For patients who undergo head CT scans at the same age, one out of 11,080 men and one out of 8,100 women will suffer from cancer as a result.

The findings come from an analysis of 1,119 patients who were given 11 of the most common kinds of examinations at four facilities in California's Bay Area last year. The amount of radiation given to patients varied.

The second study, which was conducted by National Cancer Institute researchers, estimates that about 29,000 future cancers will be linked to CT scans that were performed in this country two years ago: 2,700 cases will come from CT angiographies, 4,100 cancers from chest exams, 4,000 cancer cases from head scans, and 14,000 cancers from pelvis and abdominal CT scans.

These findings will undoubtedly cause additional worry to the over 200 patients who sued Cedars-Sinai Medical Center for Los Angeles medical malpractice after it became known that patients had been exposed to high radiation levels during CT brain perfusion scans. Over 18 months, the patients were exposed to eight times more than the usual dose of radiation that is recommended for this type of noninvasive procedure.

CT brain perfusion scans are performed about 150,000 times annually in this country.

Last week, the Food and Drug Administration announced that it was investigating whether patients treated at Providence St. Joseph Medical Center, another Los Angeles County hospital, received CT scan-related radiation overdoses In November, officials from Glendale Adventist Medical Center, also in Los Angeles County, announced that 10 patients also received radiation overdoses when they had their CT scans. The CT scanners used in the three California hospitals to perform the procedures were made by General Electric or Toshiba.

If a CT scan is a cause of someone's cancer, the patient may have grounds for filing an Orange County, California medical malpractice complaint against the medical professional or facility that recommended the procedure. A CT manufacturer could also be held liable for designing dangerous medical device that causes cancer.

Cancer Risks and Radiation Exposure From Computed Tomographic Scans, Archives of Internal Medicine

New Focus on Dangers of CT Scans, CBS News, December 14, 2009

3rd L.A.-area hospital in radiation overdose probe, Los Angeles Times, December 8, 2009

Radiation overdoses found at second hospital, Los Angeles Times, November 21, 2009

Related Web Resource:
CT Brain Perfusion Scans Safety Investigation: Initial Notification, FDA

Continue reading "CT Scans Can Increase Cancer Risk, Says Two New Studies" »