FDA Warning About Device Capable of Spreading Cancer

FDA Warns of Laparoscopic power morcellator

FDA Warns of Laparoscopic power morcellator

The U.S. Food and Drug Administration has taken action to stop the use of a gynecological device that can spread pre-existing cancer in women.  Laparoscopic power morcellators are used in the removal of the uterus, or to remove fibroids.

The device is used to destroy fibroids, which are then removed by key hole surgery.  There is no way to know if the fibroids contain cancer cells. If they do, the destruction process may released some of those cells, allowing cancer to spread to other organs.

This can lead to more dangerous forms of cancer developing, which cannot be treated as easily.

In a press release,William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health said: “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

The FDA was made aware of the flaw with this device by surgeon Hooman Noorchashm.  Dr Noorchashm’s wife, Amy Reed, had the procedure as a part of her hysterectomy and was diagnosed with stage 4 cancer.  The use of the device had spread cancer cells throughout her body.  Thankfully Amy is currently in full remission.

Whilst Dr Noorchashm was arguing for a complete ban on the device, the FDA was chosen to add a compulsory warning to the device.  The warning indicates that the device may spread cancer cells throughout the body.

The FDA chose to only use a warning because younger women may still safely use the device in their procedures.  That is due to the fact younger women are much less likely to have cancer cells in regions that can be spread.  If the device is not used, fertility can be affected.

Some hospitals have already stopped using the device, well aware of the risk before the FDA decision.  One of the companies that manufacture the device has also pulled it off the market, a sure sign that the risk of the procedure is well known.

So while this device might still play a role in certain surgeries, for older women with a higher chance of cancer, it is too risky.

FDA Approves Ovarian Cancer Drug “Avastin”

Avastin Receives FDA Approval for Ovarian Cancer

Avastin Receives FDA Approval for Ovarian Cancer

Drugmaker Roche has notified the public that the FDA has approved Avastin as a treatment for Ovarian cancer.

The new drug is designed to work in conjunction with chemotherapy in recurrent cases where there is resistance to platinum-based chemotherapy. The drug has already been approved for Glioblastoma (GBM), Metastatic Colorectal Cancer (mCRC), Non–Small Cell Lung Cancer (NSCLC) and Metastatic Kidney Cancer (mRCC).

Avastin is a angiogenesis inhibitor, that slows the growth of new blood vessels. It blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A), which is a chemical signal used by cancer to help the disease spread.

The drug was first approved in 2004 by the FDA for metastatic colon cancer. In the past Roche also tried to have the drug approved for breast cancer, but it was shown to be ineffective in trials.

The drug is a big money maker for Roche, having netted them a whopping $6.25 billion in 2013.

Side Effects
The drug carries a number of serious side effects that cancer patients must be aware of.

Some of the more serious ones are:

  • GI perforation (a hole that develops in your stomach or intestine)
  • Wounds that don’t heal
  • .

  • Serious bleeding
  • (This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding)

Other side effects can include severely high blood pressure, kidney problems, infusion reactions, stroke, heart problems, nervous system problems and vision problems.

The drug carries some serious side effects, but is an important part of the cancer treatment regime for many people.

Ovarian Cancer Symptoms

Ovarian Cancer

Ovarian Cancer


Ovarian Cancer is the 8th most common cancer in the United States. As the name implies, it is a form of cancer that affects women’s ovaries and it affects mostly older women. Women have 2 ovaries – small organs which make eggs and secrete hormones.

Symptoms and Risk Factors
It is a form of cancer that is very subtle in it’s early stages with the symptoms often continuing unnoticed. The common symptoms include pelvic pain, problems eating, bloating and frequent urination. Those symptoms are frequently found in conjunction with other illnesses so it is often difficult to diagnose early on.

Most ovarian cancers arise from the surface of the ovary, but research has suggested that the fallopian tubes may be responsible for some instances of ovarian cancer.

If you find yourself with the symptoms of ovarian cancer more than 10 times a month, then it is time to have yourself examined for ovarian cancer. So for example if you suddenly experience pelvic soreness on 5 days, have difficulty eating on 3 days, experience bloating on 4 days and are older than 50 you should seek diagnosis immediately.

Less common symptoms can include back pain, general tiredness, involuntary weight loss and an abdominal mass. The bloating and pelvic pain are usually caused by a buildup of fluid in the abdominal cavity. The pressure on the stomach from this fluid buildup is usually what causes changes to apetite also.

If you have a family member who has experienced ovarian cancer, your chances of experiencing the illness are twice as high. Unfortunately there are hereditary forms of ovarian cancer caused by gene mutations. So if you have a mother or grandmother who experienced ovarian cancer, you should consult a doctor early on if you experience symptoms, and get screened regularly when you are over 50.

Infertile women also have a higher risk of experiencing ovarian cancer as are women with endometriosis and women who have had estrogen replacement therapy.

Research has found that oral contraceptive pills are a protective factor against ovarian cancer. Long term studies have shown that women who used oral contraception for 10 years have a 50%+ reduction in their chance of contracting ovarian cancer.

Women who also had their first pregnancy at a young age also have a lower risk of contracting ovarian cancer, and women who have had their fallopian tubes blocked surgically also have lower risk.

Because the ovaries produce the estrogen and progesterone hormones that some cancers require to grow, ovary removal can halt or slow cancers that occur specifically in women (such as breast cancer).

In terms of genetic risk factors, carriers of some BRCA mutations have an increased risk of ovarian cancer. BRCA2 and BRCA1 gene mutations make up about 5% to 13% of ovarian cancers. Modern medicine allows women to understand their genetic risk factors more comprehensively so discuss this with your doctor.

Diagnosis
Initially your doctor will do a physical examination to determine if there are any masses or fluid buildup in the abdominal cavity. A blood test for ovarian cancer markers will also be conducted, that specifically looks for CA-125. An ultrasound may also be carried out.

For the diagnosis to be confirmed, surgery must be undertaken to take biopsies and inspect the abdominal cavity. Cancer cells will most likely be found in the abdominal fluid if a patient has ovarian cancer. The symptoms aren’t very useful in early stages of ovarian cancer because they can point to many other illnesses. Only at the later stages of ovarian cancer do the symptoms easily confirm ovarian cancer.

Prevention
Tubal ligation will drastically reduce the risk of ovarian cancer and some women who have a long family history of ovarian cancer may take this option. The use of oral contraceptives will halve the risk of ovarian cancer.

Regular screening and being attentive to the symptoms of ovarian cancer is one of the best ways to prevent the disease taking hold.

Treatment
Surgical treatment is an option for malignant tumors that are confined to the ovary. If the tumors are aggressive, surgery may be used in conjunction with chemotherapy.

Chemotherapy is often used after surgery to treat any tumors that are not easily removed during surgery and to stop any cancer cells spreading.

Radiation may be effective in the early stages of the illness, but due to the location of the ovaries it is not safe to use a high dose.

Unfortunately because of the difficulty in spotting the symptoms of ovarian cancer early on, prognosis is generally not good for ovarian cancer. More than 50% of women presenting with ovarian cancer are already stage III or stage IV (stage I and II being early development). By stage III and stage IV the cancer has already spread from the ovaries into other parts of the body.

Early diagnosis of ovarian cancer has a survival rate of over 80-95%, stage II has a range of 60-70%, stage III 30-45% and stage IV <20%.All up the survival rate for ovarian cancer at all stages is 47%. If caught before spreading the survival rate is 92%. The key with ovarian cancer, like many other forms of cancer, is to look at your family history, look for symptoms and get tested early!