Gynecology

July 30, 2019

Voluntary recall of textured device raises more alarms about breast implants

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.

December 2, 2018

Profiteering hospitals hit new low: billing and dunning women for rape tests

by Patrick A. Malone

NY Atty Gen Barbara Underwood

Profit-hungry hospitals have dived to some real lows in billing and mistreating patients. Seven New York facilities have gotten slapped down by the state attorney general for breaking the law by charging more than 200 women anywhere from $46 to $2,892 for collecting evidence that the patients may have been raped.

New York Attorney General Barbara Underwood, whose office conducted a year-long investigation of the abuses of state laws aimed at protecting victims of sexual violence, said in a statement, quoted by the New York Times: “Survivors of sexual assault have already gone through unfathomable trauma. To then subject them to illegal bills and collection calls is unconscionable.”

November 7, 2018

There they go again: Surgeons ‘innovate,’ but women patients get put at higher risk

by Patrick A. Malone

Women may need to double-up on their consultations with their specialists about treatment for serious gynecological concerns, as new studies have raised troubling questions about a much-touted minimally invasive surgery for early-stage cervical cancer.

These concerns, in a more perfect world, also would prompt greater questioning and oversight by doctors, hospitals, regulators, and lawmakers of surgical “innovations.”

The procedure now in question removes the uterus, part of the vagina, and other surrounding tissues via small incisions and with special laparoscopic instruments, including robots. Surgeons have advocated for this surgery rather than making a large incision in an “open” procedure, arguing the less invasive approach promotes less discomfort and faster healing for patients.

October 22, 2018

USC bids $215 million to settle gynecologist scandal, with up to 17,000 claims

by Patrick A. Malone

Yet another big university is learning a costly lesson about the perils of ignoring rogue doctors and their harming of vulnerable young people: The University of Southern California has offered to pay $215 million to settle federal lawsuits by hundreds of coeds who say they were sexually harassed and abused by the head gynecologist at the Los Angeles school’s health service.

Women who ever saw Dr. George Tyndall at a campus clinic may receive $2,500 each, while those with claims they were sexually abused by him could be paid up to $250,000 each.

USC said its proposed, tentative settlement has not been reviewed and approved by a federal judge who has been assigned a class-action suit involving hundreds of women.