MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Endologix and FDA notified healthcare professionals of the voluntary product recall of selected Powerlink System delivery catheters marketed in the U.S.,used to deliver minimally invasive treatment for abdominal aortic aneurysms.Endologix initiated the recall as a result of an analysis of three recentreports of tip separation from the catheter sheath inner core duringprocedures. This action does not include the Powerlink stent grafts thathave been implanted in patients or the large diameter 34 mm Powerlink Systembeing evaluated under an investigational device exemption or PowerlinkSystems sold outside of the U.S.
Read the complete MedWatch 2005 Safety summary, including a link to thefirm's press release, at: http://www.fda.gov/medwatch/safety/2005/safety05.htm#Powerlink
Tuesday, December 20, 2005
Friday, December 16, 2005
Law Office Reviewing Cases Involving Victims of ETS
Our office is reviewing several cases involving victims of ETS. We can answer your questions for free.
Contact Alan Friedman or Ricky Bagolie toll free at 1-866-333-3529, by e-mail at info@bagoliefriedman.com or check out our website at http://www.bagoliefriedman.com
Palmar hyperhidrosis, where the hands sweat profusely and uncontrollably, results in an unnecessary thoracoscopy with sympathectomy. It is a complex and risky procedure in which a surgeon makes an incision under the patient's armpit, inserts a surgical probe through the incision, collapses the patient's lung to gain access to the spinal area, and then severs or clamps a nerve near the spine that controls perspiration of the hands. This surgery can produce serious complications, including bleeding in the chest cavity, pneumothorax (a condition that impedes breathing), infection, significant pain, and greatly increased sweating in other parts of the body.
Contact Alan Friedman or Ricky Bagolie toll free at 1-866-333-3529, by e-mail at info@bagoliefriedman.com or check out our website at http://www.bagoliefriedman.com
Palmar hyperhidrosis, where the hands sweat profusely and uncontrollably, results in an unnecessary thoracoscopy with sympathectomy. It is a complex and risky procedure in which a surgeon makes an incision under the patient's armpit, inserts a surgical probe through the incision, collapses the patient's lung to gain access to the spinal area, and then severs or clamps a nerve near the spine that controls perspiration of the hands. This surgery can produce serious complications, including bleeding in the chest cavity, pneumothorax (a condition that impedes breathing), infection, significant pain, and greatly increased sweating in other parts of the body.
Tuesday, December 13, 2005
Serious Health Events Due To Enteryx Device
The FDA & Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with the Enteryx device.
On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Additionally, Boston Scientific Corp. recently suspended sales of it's Enteryx Device after more than two dozen reports of problems. The notice was posted on the company's Web site, during the week of September 19, 2005.
An estimated 3,800 patients have been treated with Enteryx device, which was approved in 2003 by the FDA. The company's recall notice stated some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing adverse events. Based upon reports filed with the FDA, patients suffered leakage, swelling, and ulcers in the esophagus. One elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.
Boston Scientific sold about $5.5 million worth of Enteryx kits in 2004. Boston Scientific Corp. said the U.S. Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease. Boston Scientific, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment. The agency will try to determine whether the death was linked to the device or to physician technique. We've reported this to the FDA and we're working cooperatively with them," said Paul Donovan, a Boston Scientific spokesman. FDA spokeswoman Kathleen Quinn confirmed the agency was reviewing the adverse events.
The Enteryx treatment, which the company had identified as one of its top products in terms of sales growth potential involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach. In July 2004, the company issued an alert to doctors about the product and is updating the product label. In the case of the patient who died, some of the polymer had been injected into the woman's aorta, which ruptured, causing her to bleed to death.
On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Additionally, Boston Scientific Corp. recently suspended sales of it's Enteryx Device after more than two dozen reports of problems. The notice was posted on the company's Web site, during the week of September 19, 2005.
An estimated 3,800 patients have been treated with Enteryx device, which was approved in 2003 by the FDA. The company's recall notice stated some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing adverse events. Based upon reports filed with the FDA, patients suffered leakage, swelling, and ulcers in the esophagus. One elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.
Boston Scientific sold about $5.5 million worth of Enteryx kits in 2004. Boston Scientific Corp. said the U.S. Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease. Boston Scientific, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment. The agency will try to determine whether the death was linked to the device or to physician technique. We've reported this to the FDA and we're working cooperatively with them," said Paul Donovan, a Boston Scientific spokesman. FDA spokeswoman Kathleen Quinn confirmed the agency was reviewing the adverse events.
The Enteryx treatment, which the company had identified as one of its top products in terms of sales growth potential involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach. In July 2004, the company issued an alert to doctors about the product and is updating the product label. In the case of the patient who died, some of the polymer had been injected into the woman's aorta, which ruptured, causing her to bleed to death.
Recall of Boston Scientific ENTERYX Injector Packs
Recall of Boston Scientific ENTERYX® Injector Single Packs for Treatment of
Gastroesophageal Reflux Disease (GERD)
October 14, 2005
There are serious adverse events, including death, occurring in
patients treated with Boston Scientific’s ENTERYX® for gastroesophageal reflux disease
(GERD), and to provide recommendations on avoiding future occurrences.
On September 23, 2005, Boston Scientific Corporation issued a recall of ALL
ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs from commercial
distribution. Physicians should stop injecting ENTERYX® immediately and follow the
manufacturer’s procedures for returning unused product.
Nature of the Problem
ENTERYX® is a liquid chemical polymer which is intended to be injected into the lower
esophageal sphincter. The device polymerizes into a spongy material shortly after
injection and once injected cannot be removed.
The serious adverse events involve unrecognized transmural injections of ENTERYX®
into structures surrounding the esophagus. Transmural injections can potentially result in
death or serious injury. Signs and symptoms of transmural injection can potentially
include: chest pain, flu-like symptoms, pneumonia, atelectasis, reactive pneumonitis,
mediastinitis, pneumo-mediastinum, reactive pleuritis, pleural effusion, pericardial
effusion, syncopal episodes, and flank pain. Some cases of transmural injection were not
recognized at the time of the procedure or during immediate follow-up; these occurred
even though fluoroscopy was used throughout the procedure. Three weeks was the
longest period that we know of in which a transmural injection went unrecognized by a
physician.
At this time, it is not possible to provide accurate estimates of the number of adverse
events associated with transmural injection of ENTERYX®, or to describe all of the
possible outcomes. Reports received thus far suggest ENTERYX® has been injected into
various sites outside the esophagus including the mediastinum, pleural space and the
aorta. When injected into the aorta, ENTERYX® may migrate to and occlude blood
vessels which supply other organs including the kidneys. One reported death was due to
injection of the ENTERYX® into the wall of the aorta, which resulted in an aorto-enteric
fistula. Another patient experienced a partial reduction in renal function due to partial
embolization. It is not known at this point whether ENTERYX® injected outside the
esophagus can be removed.
FDA is aware that not all injuries are caused by user technique or transmural injection.
Recent literature cites 2 cases in which serious mediastinal events suggestive of possible
inflammatory reactions occurred even though proper procedure was followed. Other
adverse events not associated with transmural injection have also been reported to the
FDA, some of them presenting 4 to 7 weeks after ENTERYX® injection. They include
dysphagia from esophageal stenosis or stricture that required dilation procedures, and
weight loss. These later-onset events appear to be different from the immediate onset,
short-lived events observed during the approval trial for ENTERYX®.
Recommendations
Physicians are advised to immediately stop using ENTERYX®.
If transmural injection of ENTERYX® has occurred or is suspected at the time of
implantation, the patient should be monitored carefully for at least 30 days.
For all patients who have received ENTERYX®, we recommend that you:
1. advise your patients to seek medical evaluation immediately if they experience
the onset of symptoms which may indicate transmural injection. These include
chest or epigastric pain, flu-like or respiratory symptoms (fever, cough, shortness
of breath), syncope or flank pain. You may wish to provide them with a copy of
FDA’s "Advice for Patients with ENTERYX® for Gastroesphageal Reflux
Disease," available at
http://www.fda.gov/cdrh/medicaldevicesafety/atp/101405-enteryx.html.
2. perform tests, as clinically indicated, including chest x-rays, barium swallows,
and/or chest/abdominal CT scans to confirm or rule out transmural injection.
3. advise patients to:
• continue with their regularly-scheduled follow-up appointments; and
• go immediately to an emergency room if they experience chest pain or
syncope.
Since physicians should no longer be implanting ENTERYX®, the FDA is not making
recommendations about techniques in using the product.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries
associated with the use of medical devices. If you suspect that a reportable adverse event
was related to the use of ENTERYX®, you should follow the reporting procedure
established by your facility. Prompt reporting of adverse events can improve FDA’s
understanding of and ability to communicate the risks associated with devices and assist
in the identification of potential future problems.
We also encourage you to report adverse events related to ENTERYX® that do not meet
the requirements for mandatory reporting. You can report these directly to the device
manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program.
You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-
FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.
Consumers can also report directly to MedWatch.
Getting More Information
For more information about the recall, contact Boston Scientific Corporation at 1-800-
862-1284. For more information on litigation, contact Bagolie Friedman at 1-866-333-3529 or visit http://www.bagoliefriedman.com
Gastroesophageal Reflux Disease (GERD)
October 14, 2005
There are serious adverse events, including death, occurring in
patients treated with Boston Scientific’s ENTERYX® for gastroesophageal reflux disease
(GERD), and to provide recommendations on avoiding future occurrences.
On September 23, 2005, Boston Scientific Corporation issued a recall of ALL
ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs from commercial
distribution. Physicians should stop injecting ENTERYX® immediately and follow the
manufacturer’s procedures for returning unused product.
Nature of the Problem
ENTERYX® is a liquid chemical polymer which is intended to be injected into the lower
esophageal sphincter. The device polymerizes into a spongy material shortly after
injection and once injected cannot be removed.
The serious adverse events involve unrecognized transmural injections of ENTERYX®
into structures surrounding the esophagus. Transmural injections can potentially result in
death or serious injury. Signs and symptoms of transmural injection can potentially
include: chest pain, flu-like symptoms, pneumonia, atelectasis, reactive pneumonitis,
mediastinitis, pneumo-mediastinum, reactive pleuritis, pleural effusion, pericardial
effusion, syncopal episodes, and flank pain. Some cases of transmural injection were not
recognized at the time of the procedure or during immediate follow-up; these occurred
even though fluoroscopy was used throughout the procedure. Three weeks was the
longest period that we know of in which a transmural injection went unrecognized by a
physician.
At this time, it is not possible to provide accurate estimates of the number of adverse
events associated with transmural injection of ENTERYX®, or to describe all of the
possible outcomes. Reports received thus far suggest ENTERYX® has been injected into
various sites outside the esophagus including the mediastinum, pleural space and the
aorta. When injected into the aorta, ENTERYX® may migrate to and occlude blood
vessels which supply other organs including the kidneys. One reported death was due to
injection of the ENTERYX® into the wall of the aorta, which resulted in an aorto-enteric
fistula. Another patient experienced a partial reduction in renal function due to partial
embolization. It is not known at this point whether ENTERYX® injected outside the
esophagus can be removed.
FDA is aware that not all injuries are caused by user technique or transmural injection.
Recent literature cites 2 cases in which serious mediastinal events suggestive of possible
inflammatory reactions occurred even though proper procedure was followed. Other
adverse events not associated with transmural injection have also been reported to the
FDA, some of them presenting 4 to 7 weeks after ENTERYX® injection. They include
dysphagia from esophageal stenosis or stricture that required dilation procedures, and
weight loss. These later-onset events appear to be different from the immediate onset,
short-lived events observed during the approval trial for ENTERYX®.
Recommendations
Physicians are advised to immediately stop using ENTERYX®.
If transmural injection of ENTERYX® has occurred or is suspected at the time of
implantation, the patient should be monitored carefully for at least 30 days.
For all patients who have received ENTERYX®, we recommend that you:
1. advise your patients to seek medical evaluation immediately if they experience
the onset of symptoms which may indicate transmural injection. These include
chest or epigastric pain, flu-like or respiratory symptoms (fever, cough, shortness
of breath), syncope or flank pain. You may wish to provide them with a copy of
FDA’s "Advice for Patients with ENTERYX® for Gastroesphageal Reflux
Disease," available at
http://www.fda.gov/cdrh/medicaldevicesafety/atp/101405-enteryx.html.
2. perform tests, as clinically indicated, including chest x-rays, barium swallows,
and/or chest/abdominal CT scans to confirm or rule out transmural injection.
3. advise patients to:
• continue with their regularly-scheduled follow-up appointments; and
• go immediately to an emergency room if they experience chest pain or
syncope.
Since physicians should no longer be implanting ENTERYX®, the FDA is not making
recommendations about techniques in using the product.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries
associated with the use of medical devices. If you suspect that a reportable adverse event
was related to the use of ENTERYX®, you should follow the reporting procedure
established by your facility. Prompt reporting of adverse events can improve FDA’s
understanding of and ability to communicate the risks associated with devices and assist
in the identification of potential future problems.
We also encourage you to report adverse events related to ENTERYX® that do not meet
the requirements for mandatory reporting. You can report these directly to the device
manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program.
You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-
FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.
Consumers can also report directly to MedWatch.
Getting More Information
For more information about the recall, contact Boston Scientific Corporation at 1-800-
862-1284. For more information on litigation, contact Bagolie Friedman at 1-866-333-3529 or visit http://www.bagoliefriedman.com
Chronology - Key events in the history of Merck's Vioxx
CHRONOLOGY-Key events in the history of Merck's Vioxx
A timeline of Vioxx's history follows:
1998
*Nov. 1998 - Merck files an application with the FDA seeking U.S. approval of Vioxx.
1999
Jan. 1999 - Vioxx Gastrointestinal Outcomes Research (VIGOR) trial begins, aiming to show whether Vioxx causes fewer ulcers and other gastrointestinal problems than the standard arthritis treatment naproxen.
*Feb. 1999 - Merck begins first clinical trial of Vioxx to see whether it can treat Alzheimer's disease. A second trial begins in April 2000.
May 20, 1999 - FDA approves Vioxx for the relief of osteoarthritis symptoms, management of acute pain and primary dysmenorrhea, or painful menstruation.
2000
March 2000 - Merck unveils data from Alzheimer's trials, which it said showed no difference in heart problems between patients on Vioxx and others taking a placebo.
June 2000 - Merck submits to the FDA final data from the VIGOR study, which it said showed a decrease in gastrointestinal problems but a four-fold higher risk of heart attacks compared with naproxen.
2001
Feb. 2001 - FDA Arthritis Advisory Committee meets to discuss the gastrointestinal VIGOR study.
2002
April 11, 2002 - FDA approves changes to Vioxx label which include cardiovascular risks, gastrointestinal benefits and a new use to treat rheumatoid arthritis.
2004
Sept. 27, 2004 - Merck tells the FDA a study to see if Vioxx could prevent colon polyps showed twice the risk of heart attacks among patients taking Vioxx for 18 months as those who took placebos.
Sept. 28, 2004 - FDA officials meet with Merck, which tells the agency it will voluntarily withdraw Vioxx. Two days later Merck announces the withdrawal.
Nov. 18, 2004 - Congress holds hearing on Merck and the FDA's handling of the drug's safety issues.
2005
Aug. 19, 2005 - Merck is found negligent in the marketing and design of Vioxx and is ordered to pay $229 million in punitive damages and $24 million for mental anguish and loss of companionship to the widow of a Texas man.
The total award is expected to be cut to about $26 million because of Texas laws limiting damages.
Nov. 3, 2005 - Merck is exonerated in a New Jersey lawsuit involving a man who suffered a heart attack after taking Vioxx but survived. The case was the first tried of thousands of cases filed against Merck in the state.
Dec. 8, 2005 - The New England Journal of Medicine says Merck deleted dangers linked to Vioxx, including three heart attack deaths among users, in its analysis of the VIGOR study.
Dec. 12, 2005 - A U.S. judge declares a mistrial in the first federal lawsuit after a jury fails to reach a unanimous verdict in a case brought by the widow of a Florida man. The case is expected to be retried in 2006.
Source: FDA--
A timeline of Vioxx's history follows:
1998
*Nov. 1998 - Merck files an application with the FDA seeking U.S. approval of Vioxx.
1999
Jan. 1999 - Vioxx Gastrointestinal Outcomes Research (VIGOR) trial begins, aiming to show whether Vioxx causes fewer ulcers and other gastrointestinal problems than the standard arthritis treatment naproxen.
*Feb. 1999 - Merck begins first clinical trial of Vioxx to see whether it can treat Alzheimer's disease. A second trial begins in April 2000.
May 20, 1999 - FDA approves Vioxx for the relief of osteoarthritis symptoms, management of acute pain and primary dysmenorrhea, or painful menstruation.
2000
March 2000 - Merck unveils data from Alzheimer's trials, which it said showed no difference in heart problems between patients on Vioxx and others taking a placebo.
June 2000 - Merck submits to the FDA final data from the VIGOR study, which it said showed a decrease in gastrointestinal problems but a four-fold higher risk of heart attacks compared with naproxen.
2001
Feb. 2001 - FDA Arthritis Advisory Committee meets to discuss the gastrointestinal VIGOR study.
2002
April 11, 2002 - FDA approves changes to Vioxx label which include cardiovascular risks, gastrointestinal benefits and a new use to treat rheumatoid arthritis.
2004
Sept. 27, 2004 - Merck tells the FDA a study to see if Vioxx could prevent colon polyps showed twice the risk of heart attacks among patients taking Vioxx for 18 months as those who took placebos.
Sept. 28, 2004 - FDA officials meet with Merck, which tells the agency it will voluntarily withdraw Vioxx. Two days later Merck announces the withdrawal.
Nov. 18, 2004 - Congress holds hearing on Merck and the FDA's handling of the drug's safety issues.
2005
Aug. 19, 2005 - Merck is found negligent in the marketing and design of Vioxx and is ordered to pay $229 million in punitive damages and $24 million for mental anguish and loss of companionship to the widow of a Texas man.
The total award is expected to be cut to about $26 million because of Texas laws limiting damages.
Nov. 3, 2005 - Merck is exonerated in a New Jersey lawsuit involving a man who suffered a heart attack after taking Vioxx but survived. The case was the first tried of thousands of cases filed against Merck in the state.
Dec. 8, 2005 - The New England Journal of Medicine says Merck deleted dangers linked to Vioxx, including three heart attack deaths among users, in its analysis of the VIGOR study.
Dec. 12, 2005 - A U.S. judge declares a mistrial in the first federal lawsuit after a jury fails to reach a unanimous verdict in a case brought by the widow of a Florida man. The case is expected to be retried in 2006.
Source: FDA--
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