Gynecology Category Archives — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

June 23, 2020

Concern rises over bias in race-based algorithms for medical decision-making

High-tech wizards may be pushing medicine into a brave new world where important medical decisions rely on supposedly data-driven findings that also may be rooted in an old malignancy: discrimination against black patients.

A new study published in the New England Journal of Medicine warns that race-based tools and formulas, algorithms aimed to assist doctors in speeding up their diagnosis and treatment in such areas as heart disease, cancer, and kidney and maternity care, improperly steer blacks away from therapies commonly given to whites without sound reasons, the New York Times reported:

“The tools are often digital calculators on web sites of medical organizations or — in the case of assessing kidney function — actually built into the tools commercial labs use to calculate normal values of blood tests. They assess risk and potential outcomes based on formulas derived from population studies and modeling that looked for variables associated with different outcomes. ‘These tests are woven into the fabric of medicine,’ said Dr. David Jones, the paper’s senior author, a Harvard historian who also teaches ethics to medical students. ‘Despite mounting evidence that race is not a reliable proxy for genetic difference, the belief that it is has become embedded, sometimes insidiously, within medical practice,’ he wrote.”

May 28, 2020

Buyer beware: J&J pulls its baby powder, as officials warn about vapeware

by Patrick A. Malone

Consumers have gotten stark reminders of the safety risks of two different kinds of products, one a household classic and the other a bootlegger’s nightmare. Caveat emptor about baby powder and street-purchased vaping devices.

As for Johnson and Johnson’s family familiar talc, the company may have timed well its decision to yank it from shelves in North America as the public focuses its attention on other and major health concerns, experts said. As Reuters reported:

“Christie Nordhielm, a professor of marketing at Georgetown, said it appears J&J made its decision to withdraw from the market while consumers were preoccupied with the pandemic. ‘It’s a nice time to quietly do it,’ she said, adding ‘it will minimize the reputational hit.’”

March 25, 2020

For 70+ women and their MDs, more reasons to rethink routine mammograms

by Patrick A. Malone

As Americans live longer, clinicians may need to reconsider whether they need to subject older patients to routine screenings that may trigger even more costly, invasive, painful, and unnecessary medical testing and procedures. For women 70 and older, for example, yet more new evidence raises doubts about mammograms designed to detect breast cancers.

As the New York Times reported, researchers in Boston examined 2000-2008 Medicare claims “to follow more than one million women, ages 70 to 84, who had undergone a mammogram.” Quoting Dr. Xabier Garcia-Albéniz, an oncologist and epidemiologist at RTI Health Solutions and lead author of a new observational study of their women subjects:

“They had never had breast cancer and had a ‘high probability,’ based on their medical histories, of living at least 10 more years. ‘That’s the population who will reap the benefit of screening,’ Dr. Garcia-Albéniz said, because it takes 10 years for mammography to show reduced mortality. The researchers divided the subjects into two groups: one that stopped screening, and another that continued having mammograms at least every 15 months. They found that mammograms provided a survival benefit, if a modest one, for women ages 70 to 74. In line with previous research, the study found that annually screening 1,000 women in that age group would result, after 10 years, in one less death from breast cancer. But among the women who were 75 to 84, annual mammograms did not reduce deaths, although they did, predictably, detect more cancer than in the group that discontinued screening. ‘You’re diagnosing more cancer, but that’s not translating to a mortality benefit,’ Dr. Garcia-Albéniz said.”

July 30, 2019

Voluntary recall of textured device raises more alarms about breast implants

by Patrick A. Malone

An Irish medical manufacturer voluntarily withdrew its textured breast implant and related tissue expanding devices from markets after the federal Food and Drug Administration tracked a spike in a rare cancer and deaths tied to the products and asked that they be recalled.

U.S. regulators, the New York Times reported, lagged their European counterparts by almost a year in acting to protect women seeking cosmetic and reconstructive procedures involving the Allergan implant:

“Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.”

June 18, 2019

UCLA ripped for poor handling of another scandal over a staff physician

by Patrick A. Malone

USC, Ohio State, Michigan State, and now, UCLA: How can big universities, with all the supposedly smart folks who head them, be so blind and deaf to student complaints that school personnel may be sexually abusing them? And why do academics keep getting caught up in situations where they appear to or may be covering up wrongdoing against the young?

Officials at the University of California Los Angeles find themselves apologizing profusely for failing to disclose that they knew of accusations of inappropriate conduct by a gynecologist on the school’s staff while treating patients in university facilities, the Los Angeles Times reported.

Women say that Dr. James Mason Heaps wrongly touched their private parts, and UCLA learned of the accusations in 2017, putting the longtime staff gynecologist on leave in 2018. The school, however, did not disclose why Heaps was gone — until criminal charges were filed against him in recent days and he pleaded not guilty to them in court.

April 22, 2019

After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures

by Patrick A. Malone

After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women.

The agency has been slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused pain, bleeding, and scarring. This was not the surgical innovation, they said, that was supposed to remedy the pelvic tissue collapse that can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary leakage.

The FDA issued a series of increasing warnings about mesh, finally reclassifying it in 2016 as high-risk and ordering its makers to produce medical-scientific evidence about the device’s long-term safety.

March 19, 2019

$29 million jury verdict in talc case underscores need for asbestos regulation

by Patrick A. Malone

Although research has shown that asbestos can cause cancer and other harmful illnesses and the federal government has sought to limit and even ban its use, yet another sizable judgment in a tainted talc case and the discovery of the substance in a popular cosmetics line shows how America’s oversight and regulation of risky materials can be too slow and ineffective.

As the New York Times reported, a jury in the San Francisco area has joined similar deliberative panels in accepting claims that longtime use of Johnson & Johnson baby power causes cancers. The state jury decided that J&J must pay plaintiff Teresa Leavitt a total of $29 million because the company knew its talc was tainted with asbestos but failed to warn her and others. Leavitt, who used the product for three decades, was diagnosed in 2017 with mesothelioma, a cancer of the lining of internal organs that is associated with asbestos.

The newspaper said the jury told J&J to pay her “$22 million for her pain and suffering, $5 million to compensate her family members, nearly $1.3 million for her medical costs and $1.2 million for her lost wages.”

March 4, 2019

FDA warns surgeons against experimental robot-aided cancer operations

by Patrick A. Malone

The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and other cancer-related procedures without caution, regulators warn.

The FDA acted after studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

Regulators also may have been prodded by their poor history in halting harms to women with so-called keyhole procedures, particularly the nightmares the FDA was slow to react to involving minimally invasive hysterectomies and a tissue-grinding tool called a morcellator.

February 21, 2019

Mothers get a big boost for counseling to help with childbirth depression

by Patrick A. Malone

Roughly 1 in 7 moms, who, during or after pregnancy, suffer debilitating depression — losses of energy or concentration, changes in sleeping and eating patterns, feelings of worthlessness or suicidal thoughts — now may get counseling that has proven helpful to women and their babies.

Preventive health experts have called on medical providers to guide women to this specialized care that could benefit 180,000 to 800,000 mothers each year. Because this treatment has been put forward this way, women also can get help affording it. As the New York Times reported, the recommendation for maternal depression counseling, by the United States Preventive Services Task Force, means insurers must cover the services — with no co-payments — under the Affordable Care Act.

Experts told the newspaper the USPSTF action was an important step on perinatal depression, noting:

January 28, 2019

For too many women, an unending and painful tangle with surgical mesh

by Patrick A. Malone

Tens of thousands of women complain that a surgery to implant mesh to bolster weak abdominal tissue, instead has inflicted on them incontinence, chronic pelvic pain as well as pains in the groin, hip, and leg, and with intercourse. Others say they suffer complications as if they had the immune system attacking disease lupus, leaving them with persistent runny noses, muscle pain, fogginess, and lethargy.

The federal Food and Drug Administration in mid-February will convene its expert panel on women’s reproductive surgeries to see advice on next steps in what has become a legal and medical morass over transvaginal mesh operations.

As many as 4 million women globally have undergone mesh surgeries to treat urinary incontinence and weakening of walls in the abdominal area that causes prolapses, the Washington Post reported, quoting a UCLA reconstructive expert as estimating that 5 percent — or 150,000 to 200,000 — of those patients have experienced complications.