Posts tagged with "FDA warning"

Other FDA Warnings

As a gynecology practice, the Northwest Ohio Center for Urogynecology and Women’s Health, often prescribes medicines that have an important place in the prevention and treatment of conditions such as heavy or painful periods, menopausal symptoms, or osteoporosis.  Medicinal therapies in the form of oral contraceptives, hormone replacement therapy, the IUD, or bone loss prevention medicines are used to significantly help women with the above problems with great successes.
As with any medicine, there is sometimes a risk to benefit ratio regarding side effects or particular dangers of the particular medicine versus the good it does that each healthcare provider should weigh with the patient being counseled. Risks with contraceptive pills or patches most often revolve around blood clots or venous thromboembolism (VTE). Most legitimate studies put that risk at 1 in 10,000 for both contraceptives and hormone replacement. Some forms of contraceptive therapy (Yazmin, Ortho-Evra) may have chemical structures that are minutely more predisposed to clot formation. In regards to the IUD, most risk is regarding insertional perforation or trauma to the uterus which is exceedingly rare according to most studies and can occur to no greater degree than with endometrial biopsy or office hysteroscopy. When talking of bisphosphonates (Fosamax) for osteoporosis, risks are mainly pointed at gastrointestinal complications like ulcers or an extremely rare condition called osteonecrosis of the jaw. Most patients who suffered these complications had histories of GI disorders or a bone cancer respectively.
The FDA, doing its due diligence, requires that pharmaceutical companies discuss these risks through a “black box” warning to inform the consumer. Unfortunately, even though these medicinal therapies have extremely positive value, a small number of people will have untoward effects as a result of these medicines. Subsequently, class-action litigation has been filed in regards to these products. Obviously, these products show continued safety overall, otherwise they would have been taken off the market. Regardless, it is up to you as the patient to discuss concerns with your healthcare provider regarding your risks and benefits when being considered a candidate for a prescription of these medicines. Please be prepared to sign or give consent stating that you have discussed the risks and benefits of the medicine before taking it and that the choice to take it is yours.

FDA Information on Power Morcellators

In gynecologic surgery, power morcellation is sometimes used during hysterectomy and myomectomy (fibroid tumor removal) to facilitate the removal of the uterus, fibroids (leiomyomas) and/or fallopian tubes and ovaries. It is a well-established as a minimally invasive surgical technique that reduces risk of intraoperative and postoperative morbidity and mortality. Without power morcellation, some patients may be ineligible for minimally invasive surgery and would be only eligible for an abdominal incision which carries higher risks of infection, bleeding, hernia formation and other morbidities. Mortality occurs at 3x the rate in open gynecologic surgery as with minimally invasive techniques. Power morcellation continues to be an option for some patients when performing hysterectomy or myomectomy. At the same time, it is critical to minimize the risks for patients undergoing these surgeries who may have occult gynecologic cancer.

Power morcellators use rapidly rotating blades or electrical energy within a tube, through which tissue is extracted. During morcellation, small fragments of tissue may be inadvertently disseminated

Power morcellation has come under recent scrutiny because of concern about the risk of intraperitoneal dissemination of malignant tissue, particularly uterine sarcoma. Various sources cite estimates of occult sarcomas from 2:1,000 to 1:350 cases. The overall incidence of uterine sarcomas is 0.64 per 100,000 women. With morcellation and dissemination, the 5 year survival rate is 15%; even without morcellation, a diagnosis of uterine sarcoma has a poor 5 year survival rate of 40%.

As with all procedures, a thorough patient evaluation is crucial and may include appropriate measures to diagnose a malignancy before surgery. Tests may include cervical cytology, endometrial sampling, and pelvic imaging. Other preoperative considerations may include age >35 years, menopausal status, uterine size, rapid uterine growth, or certain treatments or hereditary conditions. Although preoperative evaluation may improve detection of cancer, it has limitations and does not eliminate the possibility of an occult cancer, particularly sarcomas, if sarcoma is suspected or there is a known malignancy, power morcellation should not be used. Even screening for cervical or endometrial cancers may not be 100% detectable with morcellation.

Alternative treatment options to power morcellation may include manual extra peritoneal tissue morcellation which has been safely practiced for decades during both vaginal and open or mini-laparotomy cases and no definitive studies have shown dissemination of malignant tissue intraperitoneally. Although bags are in development to reduce dissemination risk during power morcellation, they have their limitations.

All inpatient surgical procedures are performed at St. Luke’s Hospital or St. Vincent Medical Center unless your insurance requires you go elsewhere.  A surgical consent must be signed in the office prior to having your procedure scheduled.

 

You may stay in hospital for 1 night or longer.  Or, you may go home the same day.  The length of stay depends on the nature of your surgery.  You will have an intravenous line to provide fluids, and a urinary catheter to drain your bladder.  Drains may be present to help drain fluid from your incision.  Medication to relieve pain and nausea will be available throughout your hospital stay.  

 

After surgery, give yourself a chance to adjust and recover.  Some women feel fine within a month.  Many need a little extra time.  Morcellation can have both physical and emotional effects that may be brief or long term.  After morcellation, periods will stop with hysterectomy and reduce with myomectomy.  A depressive emotional reaction to loss of the uterus, and remorse about permanent sterility is not uncommon or abnormal.  Please discuss any concerns with your health care provider if persistent.  Sexual response may change after hysterectomy.  If pain and bleeding have been a problem, you may feel better and have more energy as your body heals.  Once you have fully recovered, you can focus on enjoying your life.

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication

Date Issued: April 17, 2014

Audience:

  • Health Care Providers
  • Medical Professional Associations
  • Cancer Advocacy Organizations
  • Health Care Facilities/Hospitals
  • Women with Symptomatic Uterine Fibroids who are Considering Surgical Options
  • Manufacturers of Devices used for Minimally Invasive Surgeries

Medical Specialties: Pathology, Internal Medicine, Nursing, Obstetrics/Gynecology, Oncology

Product:
Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

Purpose:
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

Summary of Problem and Scope:
Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.

Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.

A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.

 Importantly, based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

Recommendations for Health Care Providers:

  • Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
  • Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
  • Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
  • Thoroughly discuss the benefits and risks of all treatments with patients.
  • For individual patients for whom, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option: 
  •  Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
  • Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.

Recommendations for Women:

  • Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
  • If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.
  • If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.

FDA Actions:
The FDA is concerned about women undergoing laparoscopic power morcellation for the treatment of uterine fibroids and the risk of inadvertent spread of unsuspected cancer to the abdominal and pelvic cavities. In an effort to enhance understanding of the problem and provide information on the appropriate use of laparoscopic power morcellators, the FDA:

  • Instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and providers;

 Will convene a public meeting of the Obstetrics and Gynecological Medical 

Device Advisory Committee to discuss: 1) the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids, 2) whether surgical techniques and/or use of accessories, such as morcellation/specimen bags, can enhance the safe and effective use of these devices, and 3) whether a “boxed warning” related to the risk of cancer spread should be required for laparoscopic power morcellators;

  • Will continue to review adverse event reports, peer-reviewed scientific literature, and information from patients, health care providers, gynecologic and surgical professional societies, and medical device manufacturers.

Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a morcellator and/or specimen bag has malfunctioned or contributed to a serious injury or adverse outcome, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Health care professionals employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

Other Resources:

References:
1 NIH Fact Sheet on Uterine Fibroids. March 2013. Available at http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=50
2 Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677.
3 Ibid.

FDA Warning on Vaginal Mesh

Vaginal Mesh Complication Surgeons | Mesh Surgery

Over the past decade, the use of mesh for treatment of pelvic organ prolapse and urinary incontinence has become increasingly common secondary to trying to improve cure rates in patients who have weak native tissue where a native repair would fail.  Many different companies have produced different materials and methods for gynecologic placement of mesh. Some of those products utilized show higher complication rates versus others. Type I macroporous, polypropylene mesh has been shown to be the best tolerated material to date due to its softness, porousity and tendency to assimilate to the body well. Howevever, unfortunately, complications can still occur with the best meshes under optimal surgical conditions with the best surgeons secondary to the permanent nature of the material.

Mesh has a proper indication for certain gynecolgic patient conditions and when placed by experienced surgeons, outcomes have been statistically shown to be excellent. Dr. Croak agrees with this statement and uses mesh for stress urinary incontinence (SUI) and abdominal pelvic organ prolapse (POP) repair when appropriately indicated. He takes the time to explain the pros and cons of mesh when needed. 

Patients that suffer from surgical mesh complications may find difficulty in receiving adequate treatment as many surgeons are not trained to handle these problems or choose not to do so because of threat of litigation. Dr.Croak has extensive experience in the proper use of mesh and the treatment of complications when they do occur. He has removed or revised over 300 mesh complication in the past several years.

Complications that are known to occur requiring potential surgical treatment include:

  • Failure of the Procedure
  • Pain (Vagina, leg, pelvic, adbominal, sexual)
  • Infection or rejection of the graft material
  • Recurrence of prolapse and incontinence with mesh
  • Recurrent urinary tract infection
  • Extrusion of the mesh into the vagina causing pain, discharge, bleeding
  • Erosion of the mesh into bowel, bladder, urethra, or rectum

FDA Communication on Surgical Mesh

Taken from www.fda.gov Medical Devices Safety Alerts & Notices (07/13/2011)

Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary IncontinenceFDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.

 

Background:  A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum.  Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.  Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

 

Talking to your doctor:  Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene.  Questions you should ask the surgeon before you agree to surgery in which mesh will be used:

  • What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
  • If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
  • What’s been your experience in dealing with the complications that might occur?
  • What can I expect to feel after surgery and for how long?
  • Are there any specific side effects I should let you know about after the surgery?
  • What if the mesh doesn’t correct my problem?
  • If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
  • If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Reporting complications to the FDA:  In order to help FDA learn more about possible problems with surgical mesh, it is important that both physicians and patients report complications that may be associated with this product.

 

You can report any problems to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or FAX.

Related Links

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Northwest Ohio Center for Urogynecology’s

Official Response to the FDA Warning
 
In 2008, the FDA put out a safety communication regarding vaginally placed mesh for pelvic organ prolapse (POP) regarding complications reported over the recent past few years. The notification and its 2011 update detailed that the FDA has received over 1,500 reports of complications during the past several years (out of approximately 250,000 vaginal mesh procedures completed) regarding vaginally placed mesh for prolapse or incontinence. Adverse events included erosion, pain, infection, bleeding, pain with intercourse, organ perforation during the surgery and urinary and/or bowel problems. Many complications potentially require further surgery or treatment and may not resolve completely. The increase in complications reported was due to more mesh surgery being performed. The communication pertained primarily to vaginal mesh placement for treatment of POP.   The FDA mandated a recall in 2012 of any of the vaginally placed POP mesh products, particularly the “kits.” Companies producing vaginal mesh kits for POP did start to remove these products from the market as early as 2012.
 

In 2014, the FDA propsed a reclassification of vaginally placed meshes from a mild to moderate risk class II device  (FDA example given of a condom) to a class III device that carries significant risk and requires pre and post market surveillance along with substantial scruntiny of performace and complications (FDA example given of a heart valve). 

 

Although risks including but not limited to erosion, pain, and scar tissue are all risks of mesh placed abdominally for POP or vaginally for SUI, the FDA excluded sacrocolpoxies and incontinence slings from the notification as it seems that not as many complications have been reported with these procedures and there are extensive studies supporting the mesh use for these procedures, thus qualifying them as the current “gold standard” for POP and SUI surgical treatment. The use of mesh abdominally or laparoscopically (i.e. sacralcolpopexy) POP and the mesh used in slings for SUI was effectively EXCLUDED and EXHONORATED by the FDA; therefore these specific meshes were not reclassified as a high risk device.


Although there are many published studies including hundreds of patients that show excellent results with minimal complications when mesh is placed vaginally for prolapse, newer conclusions have been made that most cases of prolapse do not need mesh for successful treatment therefore eliminating the risk of mesh. If mesh is to be used at all for vaginal POP repair, risks/benefits/alternatives should be extensively reviewed with the patient and all other treatment options should be exhausted.  The surgeon must ensure he/she has the proper training to correctly select patients with indications for mesh, to place vaginal mesh, and to take care of any complications that may occur.
 
 It is important to note that NO surgery is risk free.  Prolapse and incontinence surgery without mesh may be extremely complex and thus, carries similar risks of mesh augmented surgery. In many cases, non-meshed surgery carries extra risk of failure.

 
Therefore, this implies that it is NOT the mesh that is the problem in every instance. The problem may lie in how mesh is placed and in whom. Whether mesh is used or not, prolapse and incontinence surgery is advanced surgery and extra training and expertise is critical to obtaining good outcomes in patients.

Up until 2012, many companies marketed mesh “kits” for POP and SUI surgery as providing a “minimally invasive surgery” that “anyone” can learn. These companies trained many new surgeons on their use, most of whom have had minimal training in pelvic floor reconstruction.  Altruistically, these surgeons had the goal of truly helping their patients with a very frustrating problem or recurrent prolapse or incontinence- they were looking for a better tool. Consequently, from 2002-2012, there was a great increase in these type of surgeries being performed and in many cases by non-specialists. Unfortunately, just because the procedure is in a “kit,” it does not make ithe procedure simple for everyone to perform.  Most of the complications reported are in regards with these “kit” surgeries. Despite modifications and improvements to some of these kits, issues complications still arose. It does seem to be very clear that many of the complications reported can be minimized tremendously by proper surgeon experience and training. However, risks of surgery will FDA approved or recalled mesh will always be present.  The FDA, the American Urogynecologic Society (AUGS), the Society of Urodynamics Female Pelvic Medicine and Urogenital Reconstruction (SUFU) and the American Association of Gynecologic Laparoscopists have all resleased official position statements supporting FDA approved mesh usage and all have recommended improved training, credentialing and monitoring by hospitals on who should be completing these procedures, which will help decrease complications. 

Dr. Croak supports mesh use in POP and SUI surgery for the right patient. He has used it for many years in his practice with excellent outcomes and has reported his results in the peer reviewed medical journals. Dr. Croak will continue to use mesh when indicated, while appropriately providing informed consent of potential risks of mesh as well as alternatives such as biologic grafts. Without using augmentative materials, Dr. Croak would not get high cure rates when compared to “traditional” surgery without mesh in people with poor tissue strength. He supports the FDA notification entirely. The Northwest Ohio Center for Urogynecology and Women’s Health wishes to make themselves readily available to their colleagues and  patients to assist with any issues or concerns regarding mesh complications. Many complications are small extrusions and may be simply handled if they are addressed early and appropriately!

If litigation, either class-action or directed, is being considered by the patient, it is imperative that they inform Dr. Croak of this consideration.
He is sympathetic to every patients’ situation but will need to review the case individually, and does reserve the right to decline acceptance of care.  Please understand that Dr. Croak needs to do his job as a physician and keep his priorities on his office and hospital practice first and foremost. By taking on mesh complication cases out of his willingness to help those with problems, he unfortunately has been forced to delegate an ever increasingly disproportionate amount of time towards subsequent litigatory efforts. This is not why Dr. Croak became a physician. It is with great reluctance, that as litigation regarding mesh complications has increased, Dr. Croak has begun to limit the cases he will see because of this burden to his practice. To put this sensitive point in perspective, several of the best and largest academic medical centers in the country have recently instituted policies of refusing to even see mesh complications if their surgeons did not perform the original surgery. 
 Please be expected to sign a waiver relinquishing Dr. Croak from any and all risk of litigation if you wish to have him assist you with your situation.