Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
Twitter: JjrkCh

Monday, February 1, 2016

How Many Adverse Events Does It Take to Get Bayer Essure Recalled By FDA? MORE !!!$$$???

Birth-control device under FDA review

By Maryellen Fillo, Conn. Health I-Team Writer | February 1, 2016 (FiDA highlight)

Alyson Hannan, of Farmington, is among the women who have had problems after having the Essure birth-control device implanted.

When Alyson Hannan, 44, decided she was done having children, she chose Essure, a non-surgical, permanent birth-control option approved by the Food and Drug Administration.
The day the tiny metal coils were inserted into her fallopian tubes in her doctor’s office is one that she can’t forget, said Hannan, regional sales director for Met Life who underwent the procedure on Sept. 11, 2014. “I will never forget that date. None of us will.”

Hannan is among tens of thousands of women, now referred to as “E-Sisters,” who have banded together on Facebook to share their stories of adverse health problems, including allergic reactions, chronic pelvic pain, device migration, hair loss and headaches.

Their public clout and a citizens’ petition prompted the FDA to launch a review of Essure, and U.S. Rep. Mike Fitzpatrick (R-Pa.) to sponsor legislation calling on the FDA to withdraw its approval for use. The controversy will come to a head in February, when the FDA is expected to complete its review, and when members of the “Essure Problems” Facebook group are heading to Washington to lobby Congressional members to support Fitzpatrick’s “E-Free Act.”
The concerns over Essure have been fueled by a January report by a federal watchdog agency, conducted at the request of U.S. Rep Rosa DeLauro, a Democrat from Connecticut’s 3rd Congressional District, that faulted the FDA for failing to adequately track and disclose safety concerns that arise after drugs go on the market. Inspectors from the Government Accountability Office expressed particular concern about the lack of tracking of products cleared under two expedited approval programs.

The lack of inadequate pre-marketing and post-marketing studies of Essure was highlighted in a recent article in the New England Journal of Medicine that was co-authored by Yale University School of Medicine researchers.
DeLauro, was among the first members of Congress to speak out against Essure, writing to the FDA in October to say she was “deeply disturbed by reports from women about severe adverse health effects they have suffered…” and calling on the agency to withdraw Essure from the market.
Essure, approved by the FDA in 2002 for women ages 21 to 45, is a flexible coil that is inserted into each fallopian tube in a doctor’s office. Essure is made of nickel titanium alloy and a polyester-like fiber called polyethylene terephthalate, or PET. The procedure, performed in a doctor’s office, takes about 10 minutes. The medical device was originally manufactured by Conceptus, which was purchased by Bayer HealthCare in 2014. Once inserted by an OB-GYN, scar tissue forms around it, blocking the tubes and preventing eggs from being fertilized.
Varying experiences
An estimated 750,000 women have received Essure. Warnings on the product include side effects such as mild cramping, vaginal bleeding and some temporary discomfort.

In response to the public outcry, Dr. Dario Mirski, Bayer’s vice president and head of U.S. medical affairs, said, “Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.”
“We continue to be committed to maintaining an open dialogue with any patient who has questions or concerns about Essure,” Mirski said in a press release.
The FDA has received 5,093 medical device adverse reports on Essure, a majority of them citing abdominal pain, irregularities in menstrual cycles, fatigue and possible nickel allergy. Some women have reported perforation of the uterus and/or fallopian tubes or intra-abdominal or pelvic device migration. Four adult deaths and five fetal deaths were also reported, according to the FDA.
In September, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to discuss the risks and benefits of Essure and received over 2,800 written public comments. The FDA said that it expects to complete its review by the end of February.
In the meantime, members of the “Essure Problems” Facebook group are heading to Washington on Feb. 2 to speak to Congressional members to garner support for Fitzpatrick’s “E-Free Act.”
In Connecticut, doctor’s opinions on the device vary. Dr. Henry Jacobs, an OB-GYN and president of the Connecticut State Medical Society, said he used Essure when it was first introduced, but does not generally use it now, opting instead for tubal ligation, another permanent sterilization procedure.
“There were too many factors that made me say, ‘Hey, I can do this another way’,” Jacobs said. “I think Essure is worthy of a review.”
Dr. Russell Turk of the Stamford Health Medical Group said, “Overall I feel it is good but I have had a couple of things occur but nothing bad.”
“As with any form of contraception, there are always benefits and risks,” Turk said, whose office is in the Riverside section of Greenwich.
Turk said he does the outpatient procedure in Stamford Hospital’s Tully Health Center, rather than his office.
“I don't like the idea of fishing around in a uterus in an office setting,” said Turk, noting some bigger medical groups might have more sophisticated equipment.
He said he goes to the center because “sometimes there can be problems with the insertion and if that happens we have other options like a laparoscopic tubal and are in a safe setting with the right equipment and can proceed.”
At first, Turk said he instructed his patients who wanted the Essure device to have a nickel allergy test but was advised it wasn’t necessary. He said he has never had a patient who suffered any allergic reaction to the device.
“I do ask patients if they have a nickel allergy or if they think they might,” Turk said.
Turk said his patients have requested Essure and he offers it.
“I don’t think anyone feels there is never a possibility of something going wrong,” he said. “There is no perfect form of contraception other than abstinence.”
‘E-Sisters’ ranks grow
Dr. Odie Kuiper, an OB-GYN in Avon, said he has used Essure nearly 200 times with no reported problems, but is very careful to review risks with his patients.
“I understand the request for (FDA) review, because no one wants anything that is not safe for a patient,” he said. “But I don’t think the adverse effects are common enough to take the device off the market.”
Angela Desa-Lynch of California, one of the founders of “E-Sisters,” doesn’t want to leave the decision up to the FDA.
“In 2011, when we started the page, we had just 130 women — at a time when the horrible side effects of the implant were not well publicized, and everything was all gumdrops and candy canes,” she said. “Now we are over 25,000 members, and our mission is to save other women from what we have been through.
Desa-Lynch, the mother of two sons and a daughter, had a hysterectomy to remove the coils, after it was determined she was allergic to the materials used in the device.
“I lost my hair, my teeth and felt like I always had the flu,” she said.
“It changed my life, and I don’t want my daughter to ever have it as an option. I don’t ever want her to have the opportunity to choose Essure,” she added.
Angie Firmalino, another founder of the Facebook group, said the goal is to get the device off the market.
“We plan to continue to garner for support of the ‘E-Free Act,’ ” said Firmalino, of New York. “We suspect the FDA report will call for minimal requirements for the manufacturer to change labeling and such. We need Congress to act and revoke the pre-market approval of Essure so that the civil rights of women harmed by Essure can be restored.”
Hannan, of Farmington, has coped with years of severe backache and pelvic pain; long, heavy periods; insomnia; fatigue; weight gain; and a rash and boils that covered her body. She’s missed work, her children’s activities and other social events because of the way she feels and looks.
“It has been a nightmare,” said Hannan, who is scheduled for a hysterectomy in early February to remove the coils. “I don’t think the doctor had any reason to not believe it was safe until it was too late,” she said.
Hannan’s doctor, Jennifer Grant, who is in practice at the Women’s Comprehensive Health Center and on the staff of Hartford Hospital, will perform the hysterectomy. She said that she has used the Essure device for over eight years, and that Hannan is the only one to report a problem.
“I am very curious to see if her symptoms improve after it is removed,” she said.
Hannan is convinced that once the device is removed, her health will improve. But her longer-term mission is to protect other women from the device.
“I honestly feel the product was fast-tracked due to money, and in the quest to make money, they ignored what happened to 25,000 women,” she said. “I just want it out of me. I just want to be well again.”
This story was reported under a partnership with the Connecticut Health I-Team (

Tuesday, January 26, 2016

2008 Poison Pill - Congress snubbed, Patients exploited, Bush legacy: 'get-out-of-jail-free' for corporations

Updated Oct. 15, 2008 11:59 p.m. ET

WASHINGTON -- Bush administration officials, in their last weeks in office, are pushing to rewrite a wide array of federal rules with changes or additions that could block product-safety lawsuits by consumers and states.
The administration has written language aimed at pre-empting product-liability litigation into 50 rules governing everything from motorcycle brakes to pain medicine. The latest changes cap a multiyear effort that could be one of the administration's lasting legacies, depending in part on how the underlying principle of pre-emption fares in a case the Supreme Court will hear next month.

This year, lawsuit-protection language has been added to 10 new regulations, including one issued Oct. 8 at the Department of Transportation that limits the number of seatbelts car makers can be forced to install and prohibits suits by injured passengers who didn't get to wear one.
These new rules can't quickly be undone by order of the next president. Federal rules usually must go through lengthy review processes before they are changed. Rulemaking at the Food and Drug Administration, where most of the new pre-emption rules have appeared, can take a year or more.
The Bush administration's efforts to protect corporations that comply with federal rules from legal action have fueled a long-running power struggle between business interests, which support the efforts, and consumer groups and trial lawyers who have denounced the moves.
The U.S. Chamber of Commerce's Institute for Legal Reform supports pre-emption as part of its campaign to "neutralize plaintiff trial lawyers' excessive influence over the legal and political systems," according to its Web site. "It's exceedingly difficult for companies to comply with 50 different state standards," the Institute's president, Lisa Rickard, said in an interview.

The American Association for Justice, the trial lawyers' lobby, is trying to formulate a strategy to undo pre-emptive rules. "This is the gift that keeps on giving for corporations," said the association's chief executive, Jon Haber.
The use of rulemaking to protect corporations from product liability was discussed from early in the Bush administration, said former Bush domestic-policy adviser Jay Lefkowitz, who was instrumental in the process.
One administration concern was the spiraling number of multimillion-dollar product-liability lawsuits against corporations based on state "failure to warn" rules, said Mr. Lefkowitz and other former administration officials. Some state consumer-safety laws on product warnings are tougher than, and conflict with, federal standards, particularly in the pharmaceutical area.
"You can't ask companies to follow different standards," Mr. Lefkowitz said. The lobby for drug makers, the Pharmaceutical Research and Manufacturers of America, says that such inconsistencies on drug labels "may be, at best, confusing, or at worst, life-threatening."
The Office of Management and Budget, which reviews regulations, has denied there has been a top-down plan in the administration to end lawsuits via regulatory changes. But in March, the OMB directed wording on railroad-tank-car safety. According to an email titled, "Preemption language for the preamble in the tank car rule," the Federal Railroad Administration and the Pipeline Hazardous Materials Safety Administration, part of the Department of Transportation, were asked to use OMB's pre-emption wording. The rule hasn't been finalized.
Some federal rules protecting industry from litigation:
  • MATTRESS FLAMMABILITY Rule requires mattresses that burn more slowly. Prevents suits if consumer is injured in fire.
  • DRUG LABELING A rule makes the FDA responsible for the wording of label warnings. Companies that comply get protection.
  • RAILROAD SAFETY Requires stronger construction for rail cars carrying hazardous materials. Suits barred if cars catch fire.
Mr. Lefkowitz said the administration decided not to press its pre-emption agenda in Congress, where it might lose. "There was already authority within federal government statutes and regulations to start the reform process without legislation," he said. "Using that and legal briefs, we proceeded."
The FDA began entering lawsuits and submitting briefs on the side of drug makers and supporting federal pre-emption in 2001, though the agency previously supported the right to sue. The Supreme Court will hear arguments next month in a case called Wyeth v. Levine that will be a big test of federal pre-emption authority. Diana Levine, a musician, lost an arm to gangrene after receiving an antimigraine drug made by Wyeth in a hospital emergency room. She claims the company didn't adequately warn about side effects under Vermont law. Wyeth says it followed federal warning-label standards and is protected from Ms. Levine's claims.
The FDA, through the Justice Department, is defending pre-emption in that case, citing its own 2006 rule that says federal safety regulations trump state ones.
Pre-emption regulations are already affecting some pharmaceutical suits. The state of Alaska recently settled a case with Eli Lilly & Co. to recoup medical costs for the antipsychotic drug Zyprexa for $15 million, a fraction of the original amount demanded, because of the Wyeth case, which could undo a large jury verdict, said the state's assistant attorney general Ed Sniffen.
Write to Alicia Mundy at

@aliciamundy FDA hears from #Essure patients this week about harms from this birth control. Will you be listening?
9/22/15, 1:32 PM

Tuesday, January 19, 2016

J&J Medical Devices Cut 6% of Staff: No Mention of Patient Harm/Pending Lawsuits

Johnson & Johnson to cut about 3,000 jobs in medical devices

JANUARY 19, 2016 3:04 PM

AP Business Writers

Johnson & Johnson said Tuesday that it plans to cut about 3,000 jobs over the next two years as the health care conglomerate works to restructure its medical devices business.
The New Brunswick, New Jersey, company said that amounts to more than 2 percent of its global workforce of around 127,000 people and 4 percent to 6 percent of its employee total in medical devices.

The cuts come after a tough year for the healthcare bellwether, which has seen sales of its prescription drugs, devices and consumer medicines squeezed by a weakening global economy and unfavorable currency exchange rates.
"These actions recognize the changing needs of the global medical device market," said Gary Pruden, chairman of Johnson & Johnson's medical device unit, in a statement.
The restructuring focuses on the company's orthopedics, surgery and cardiovascular businesses. It won't affect consumer medical devices, pharmaceuticals or consumer businesses.
J&J has struggled to revive sales of medical devices, particularly brands like DePuy orthopedic implants and Ethicon surgical equipment. In October the company said device sales dropped 7.3 percent to $6.1 billion in the previous fiscal quarter. In the same month, J&J sold its Cordis heart devices unit, which previously accounted for about one-quarter of device sales.
Wells Fargo analyst Lawrence Biegelsen noted that medical devices have been "one of the weaker performing businesses in recent years."
"As such, we believe that the restructuring should be a positive step towards driving longer term growth of the business and enhance profitability over time," Biegelsen said in a note to investors.
The company's actions will lead to annual pre-tax savings of $800 million to $1 billion, much of which will be realized by the end of 2018. J&J said it will consider "strategic options" for underperforming business units.
J&J will book a fourth-quarter charge of about $600 million in connection with the restructuring.
Leerink Swann analyst Danielle Antalffy said Tuesday's announcement increases the likelihood of an acquisition to boost the company's medical device prospects. She notes J&J has roughly $37 billion in cash.
Citing conversations with J&J executives, Antalffy states "it's clear to us that it's a matter of when, not if J&J does a deal."
J&J shares rose 4 cents to $97.04 in trading Tuesday. Its shares have fallen more than 6 percent over the past year.

Read more here:

Thursday, January 14, 2016

Obama is a fox: Califf is the wolf. FDA headed to obsolescence?

Will Commissioner Califf Lead the FDA to Obsolescence? The Answer is Likely Yes.
by Marcie Jacobs                 December 2, 2015         FiDA highlight
The more I think of Obama and his ways, the more I think he is playing chess. He certainly was playing chess with the ACA by pitting large employers and employees (169 million strong) and insurance companies and policyholders against big medicine and now this with the FDA. He knows the FDA runs counter to his mission so what does he do? He appoints a wolf to guard the henhouse. Why? It doesn't make sense unless he is trying to wake us up to smell the coffee. Any other way he dealt with the corrupt FDA would land him in hot water with his contributors and it wouldn't solve the problem. Most doctors come from the same cesspool as Califf and are practicing allopathic medicine because they can't break free from it. It was too profitable for them pre-ACA and now they believe they are trapped.  In addition, anyone he appointed would eventually do the same as our good ole boy Deputy Commissioner Califf.
From a post by Johanna Ryan, The Ghost of Research Future

"Two facts about Robert Califf are beyond question. He is an expert on clinical trials, who is already seen as a leading architect of the future of medical research. And as the New York Times put it, he has “deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory. A lot of senior figures in medicine support Califf in spite of his ties to Pharma. The guy is just so bright, and understands the nuts and bolts of drug research so well! Surely a person like this is more useful than some outsider who offers only a squeaky-clean resume, they argue."

For the sake of argument assume that he does become "The Ghost of Research Future" Ghost is a good word to describe an agency that has already lost its reputation and is about to lose all credibility in the eyes of consumers.  Like medicine, research in this country is being transformed and technology and big data are leading the way. In the future, the management of illnesses will be based on our unique genetic makeup.  Clinical trials will no longer be necessary; they are population-based research; the future of research is individual-based and unique for all of us.  And consumers will demand studies and treatment based on their genome. And they will prevent, treat and maintain their disease based on their own unique biological makeup, not something dictated by corrupt agencies within the government that operate at the benefit of big medicine and big pharma and not for the benefit of patients/consumers. 

Consumers in the new healthcare paradigm will become increasingly hostile towards FDA approvals. If it has the seal of approval from the FDA it has the seal of disapproval from consumers. Consumers will use FDA corruption against them.  Extra, extra read all about it, FDA approves the next new blockbuster drug and no one buys it. Company's revenue drops by double digits.  

So what does Obama accomplish by appointing a wolf? He wakes up the American people on both sides of the aisle and he shows us that the FDA is an organization that can't be trusted. And that lesson is invaluable if you want to stay alive in the 21st century.  It puts the ball in our court. We the People are the ones that will chop down the greed, not the corrupt politicians or the pharma-run cronies at the FDA. It is a brilliant move, force the American people into the battle and soon they will dismiss anything that comes out of the FDA and in doing so they will protect themselves and their families.

In the 21st century, it's all about the individual and their genetics so population-based research (Califf's baby) is out and the FDA is one step closer to obsolescence.  The FDA can control providers, inventors, and corporations, but they cannot control the consumer.  That is why it is up to us to control the market and medical drugs and products as well as what we eat by taking our health care dollars elsewhere no matter who pays.  

Saturday, January 9, 2016

Tort Reform: Not Intended to Shut Courthouse Door to Victims

Trial lawyer Steve Mostyn and tort reform advocate join forces

Posted: 6:24 p.m. Friday, Jan. 8, 2016
By Tim Eaton - American-Statesman Staff

One of the most vocal tort reformers in recent years, Mike Hull, has joined forces with trial lawyer and big Democratic donor Steve Mostyn, an unlikely partnership that is sure to turn heads under the Capitol dome.
The Hull Henricks firm has been working with lawyers from the Mostyn Law Firm for about two months on one of the largest collection of medical lawsuits in U.S. legal history, Hull told the American-Statesman.

Lawyer and former outside counsel for Texans for Lawsuit Reform Michael Hull.
Mostyn’s firm has been suing manufacturers of surgically implanted transvaginal mesh, which doctors have used to treat some conditions following childbirth, for two years. Plaintiffs have said the mesh has caused painful infections, bleeding and other problems.
The new arrangement stands in sharp contrast with the way Hull and Mostyn used to interact.
Hull had been working tirelessly against Mostyn and his interests for the past several years as one of the Capitol’s most recognizable tort reform advocates and as the outside counsel for Mostyn’s most well-funded detractors at Texans for Lawsuit Reform.

Trial lawyer Steve Mostyn.
Hull called his relationship with Mostyn over the past decade “as cordial as it could have been,” but he quickly admitted that “we were not going to dinner.”
The strange-bedfellow collaboration with Mostyn hasn’t changed Hull’s outlook. He still considers himself a tort reform advocate.

“I am a fan of the work I did,” Hull said. “But that work was never intended to shut the courthouse door to people who have been victimized.”

Friday, January 8, 2016

The Supreme Court Blocks Civil Rights of Medical Device Harm Citizens

Essure Harm Shielded by the Supreme Court

Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.

FRIDAY, JANUARY 8, 2016, 10:52 AM

One of the underlying tenets of our free-market is that consumers alleging harm should have legal recourse in our court system. And the 14th Amendment of our Constitution guarantees citizens equal protection under the law.

So, if a product or service is unreasonably harming people, the court system usually provides feedback to the supplier and problems are removed.

But, if legal barriers prevent consumers from taking their cases to court, harmful products and services will persist in the market.

That’s the scenario playing out in the multi-billion-dollar medical device sector of our economy.

Most Americans do not realize that when the Food and Drug Administration (FDA) approves “high-risk” devices through its “Pre-Market Approval” (PMA) pathway, these devices are automatically shielded from litigation. This shield was created by the Supreme Court in the 2008 decision, Riegel v. Medtronic.

You can read about Riegel v. Medtronic here and here.

The presumption is that if and when a PMA device harms people, recourse will be provided through FDA review. But, unfortunately, FDA and, in particular, its Center for Devices and Radiological Health (CDRH) is a “captured” agency. What that means is that the FDA process is overly influenced by industry advocates, at the expense of patients.

Here is a clear example of why CDRH is considered a “captured” agency by prominent FDA watchdog groups.

When the federal government, on the one hand, blocks consumers’ access to state courts and, on the other, takes on the job of addressing allegations of harm outside of a courtroom, that’s not the free-market working - it’s Big Brother at work. And that’s the process protecting PMA-approved devices.

A specific example of this problem is playing out in the case of a device used to permanently sterilize women. This PMA-approved device is known as Essure, made by a German company, Bayer Health.

You can read about Essure here and here.

More than 25,000 women across the United States claim they have been harmed by Essure, but they do not have access to the state court system.
FDA did conduct a hearing on Essure in September 2015, but last I checked FDA is not an arm of the Department of Justice.

Pennsylvania Congressman Mike Fitzpatrick is fighting to overturn Riegel vs. Medtronic.

On Dec. 6, he introduced an amendment proposing the removal of all barriers to civil litigation in product liability cases against medical devices.

You can watch him introduce this amendment here at 41:50.

But Fitzpatrick’s amendment was rejected, based on technicalities, by the House Rules committee. So it will not come up for a vote in the House.

Incredibly, those voting against the amendment were Fitzpatrick’s Republican colleagues – the supposed guardians of “free-market” economics and vocal critics of federal government protectionism over the market.

Democrats are also rejecting rep. Fitzpatrick’s call to remove Essure from the market, despite many in that party who advocate for women’s health and patient safety. The party machine won’t support Fitzpatrick’s E-Free Act.

Meanwhile, Bayer is defending its product and claiming that the harm done to a relatively small group of otherwise healthy women is to be accepted given the product’s supposed benefits.  

But our country was built on protecting minority groups who are wrongly harmed.

Fitzpatrick’s position on Essure and Riegel offers Republicans an opportunity to live up to their free-market ideology and to claim women’s health as a real Republican platform – but many are failing to see this. 


Monday, January 4, 2016

Pelvic Surgical Mesh Regulation: Too Little, Too Late!

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

For Immediate Release
January 4, 2016
FiDA highlight & comment
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. *
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.
Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.
Manufacturers of surgical mesh to treat POP transvaginally will have 30 months,(June 2018) as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.
Doctors may perform surgery on women with POP who have significant symptoms, often using a minimally invasive transvaginal technique to reduce recuperation time. Surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair POP, but over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has:
  • Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures;
  • Convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair;
  • Issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP; and
  • Issued two proposed orders in May 2014 to reclassify the devices from class II to class III and to require manufacturers to submit a PMA application.
Manufacturers may choose to submit a PMA before the 30-month deadline.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.