Wednesday, August 23, 2017

Ethicon launches ProxiSure Suturing Device, improving precision in Minimal Invasive Surgery


Ethicon, part of the Johnson & Johnson Medical Devices Companies, announced today the U.S. launch of the ProxiSure™ Suturing Device, an advanced laparoscopic suturing device armed with Ethicon endomechanical, suture and curved needle technologies.

ProxiSure Suturing Device boasts wrist-like maneuverability and curved needle suitable for operating in tight spaces giving surgeons confidence similar to open surgeries. The suturing precision and ease is achieved because surgeons can reach the desired angle, control bites and and secure knots, with having maximum control of the needle during suturing and knot tying all along.




Dr. Niels-Derrek Schmitz, Franchise Medical Director for Ethicon said, "With the patient's health at the forefront of our thinking, we aimed to introduce a suturing device that will help reduce the margin of error in minimally-invasive surgery. Surgeons will now be able to have the same confidence in laparoscopic suturing that they have always had with traditional procedures using Ethicon products."

"Versatility is the key," said Dr. Schmitz. "ProxiSure enables surgeons to do a wide range of tasks in the OR while maintaining an immensely user-friendly configuration." 

ProxiSure Suturing Device is suitable for use in gynecological procedures, bariatric, general and colorectal surgeries, enabling the surgeon to suture a variety of tissue layers, including flat surfaces.


                                    PROXISURE™ Suturing Device In-Service



Media Courtesy: Ethicon.



Tuesday, August 22, 2017

Johnson & Johnson to pay $417 million to a ovarian cancer patient: a blockbuster verdict by Jury



In a landmark decision, a jury has ordered Johnson & Johnson (J&J) to pay $417m (£323m) to a woman who claimed she developed ovarian cancer after using the company’s talc-based products such as Johnson’s Baby Powder for feminine hygiene.

The verdict was given in favor of California resident Eva Echeverria,who claimed that she developed terminal cancer after decades of use of J&J’s products.



This is the largest payout yet with J&J facing thousands of lawsuits (4800) for failure to warn the consumer about cancer risk of its talc based products.

“We are grateful for the jury’s verdict on this matter and that Eva Echeverria was able to have her day in court,” said Mark Robinson, her lawyer, in a statement.

Her lawyers argued that the company continued to market and encourage women to use its talc based products, despite aware of its carcinogenic potential.

Earlier, a Missouri jury has awarded $72 million to the family of an Alabama woman who died from ovarian cancer in October 2015.

Despite being named as baby powder, it is used by millions of adults in sensitive area to prevent  chafing or promote dryness.

In its natural form talc contains asbestos, a proven carcinogenic since decades.American Cancer Society states,” When talking about whether or not talcum powder is linked to cancer, it is important to distinguish between talc that contains asbestos and talc that is asbestos-free. Talc that has asbestos is generally accepted as being able to cause cancer if it is inhaled. This type of talc is not used in modern consumer products. The evidence about asbestos-free talc, which is still widely used, is less clear.”

It is postulated that if talc or a product containing talc is applied to your genital area in any way (whether it’s applied directly — what’s called perineal talc use —  or whether it makes its way there via pads, condoms, etc.), the powder particles might be able to travel from your vagina all the way up to your ovaries.

This may set off inflammation, which is believed to play an important role in etiology for ovarian cancer.

Many studies have looked into possible link between talc use and ovarian cancer, but the findings are equivocal. A 2003 meta-analysis of 16 studies (11,933 patients) found a link between talc use and ovarian cancer while a 2014 study of 61,576 women did not find the same link.

Meanwhile J&J said, “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder.”

So, the bottom line is we still do not have sufficient evidence to prove causation. FDA states that, “There is not sufficient evidence to prove a possible connection.” However, after a flurry of recent lawsuits The U.S. FDA Office of Women's Health has agreed to fund a study investigating the possible link between cosmetic talc use and ovarian cancer.

A posting on the FDA's website notes that while women are commonly known to use products containing talc for hygiene and cosmetic purposes, talc's effects on the tissues that make up the female genital system have not been adequately investigated.

Till causation is proved, the consumers are advised to play it safe and can use talc free powders. A lot of companies make talc-free baby powder out of cornstarch, including Johnson & Johnson.



Monday, August 21, 2017

Are you dense? What every woman and her healthcare provider needs to know.

courtesy: Are you dense


Nearly 20 plus years of research have provided sufficient evidence to link dense breast tissue and increased risk of missing cancer diagnosis by screening mammography. As the breast density increases, the reliability of mammogram as a screening tool for picking up breast malignancy decreases.

What is meant by “being dense”? Breast density does not correlate with physically palpated firmness of breast, it is a radiologic finding and cannot be predicted without obtaining a mammogram. 

Mammographic breast density is defined as the relative amount of radio-opaque (white) elements to radiolucent (black) fat on the image. Increase in the proportion of radio-opaque elements leads to greater mammographic breast density.

Radiologists find it difficult to distinguish between tumor and normal dense tissue, both of which appear white on a mammogram.

In fact, mammography will only detect 30% cancer in dense breasts and 80% in non-dense breasts.
Nearly 40% of women have dense breast, which means that only using mammography as a screening tool puts this population at high risk of missing the diagnosis, delayed diagnosis or diagnosis at very late stage of disease. A recent search of PubMed revealed nearly 3,027 studies on masking risk of dense breast tissue.

Increased density of breast is a casual as well as masking risk factor for breast cancer. According to the American Cancer Society, having heterogeneously or extremely dense breast tissue puts you at risk of breast cancer that is equivalent having one first-degree relative with breast cancer. (2.1 to 4 times the normal risk)

Also, women with dense breast are put at increased risk of developing contralateral breast cancer and interval cancer (cancer detected within 12 months of a normal mammogram)

A recent Breast Cancer Surveillance Consortium study noted that breast density exceeds all other risk factors like obesity, family history and delayed childbirth.

About 28 states in USA have passed law regarding the mandatory reporting of breast density and the necessary follow up thereafter, after women have a screening mammogram.

So, is there a standard protocol for supplemental screening if a woman is diagnosed of having dense breast on screening mammogram? No, unfortunately not, the medical community has not agreed on a protocol regarding supplemental screening for women with dense breasts.

In a position statement, the ACOG, identifies dense breast as a moderate risk factor but does not support routine use of adjunct screening modalities in an average risk woman with dense breast. The American Cancer Society urges the patients with dense breast to talk to healthcare providers about additional screening modalities and advises an MRI along with her yearly mammogram in a high-risk group.

The American College of Radiology identifies breast density as a controversial risk factor for breast cancer with no consensus that it confers sufficient risk to warrant supplemental screening.

At this time, it is highly suggested that patient should initiate a dialogue with her physician, regarding the protocol to be followed after the diagnosis of dense breast. Each patient should be individually evaluated about her risk of breast cancer based on her genetics, family history and other risk factors.

One suggested approach based on a paper presented by Lee C. at Society of Breast Imaging/American College of Radiology Breast Imaging Symposium; April 26, 2015; Orlando, FL is to use tomosynthesis for all levels of risk, supplemental whole-breast ultrasonography for women with average risk, and supplemental magnetic resonance imaging for women with intermediate and high risk

For women who are at high risk and also have a contraindication to magnetic resonance imaging, whole breast ultrasonography or molecular breast imaging, if available, may be an appropriate alternative.

courtesy: https://www.moffitt.org/media/6369/125.pdf



The current options available in addition to screening mammography are Tomosynthesis or 3D mammography, Ultrasound, Magnetic Resonance Imaging (MRI), Molecular Breast Imaging (MBI) or Breast Specific Gamma Imaging (BSGI) and Contrast Enhanced Spectral Mammography (CESM)

Nancy M. Cappello, Ph.D. has founded Are You Dense, Inc., and Are You Dense Advocacy, Inc., to educate women and general public about the challenges women with dense breast face regarding the screening tools for detecting early breast cancer.

Classification of Breast Density: American College of  Radiology. 

click to enlarge