Tag Archives: safety

NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance

National Center for Health Research: December 13, 2018


Comment of the National Center for Health Research Regarding the
510(k) Third Party Review Program:
Draft Guidance for Industry, FDA Staff, and Third Party Review Organizations.
OMB Control Number 0910-0375

The National Center for Health Research (NCHR) is a non-profit organization which conducts original research to better inform policy makers, health professionals, and patients.   NCHR accepts no funding from any entity which manufactures or distributes medical products.

We appreciate the opportunity to comment on this draft guidance.  We note that this draft guidance applies to low-to-medium risk medical devices, which concerns us because many Class II devices are permanent implants that have the potential to cause permanent harm to patients.  In fact, our research indicates that even Class I devices have been subjected to high-risk recalls by the FDA due to the potential for causing death or permanent harm.1 2 3

We have several serious concerns about the draft guidance.  First, Original Equipment Manufacturers (OEM) are accountable for the efficacy and safety of their medical devices.  FDA standards require that devices manufactured by OEM’s comply with relevant regulatory standards.  OEMs are required to track, monitor, and report product issues to FDA.  Overseeing the OEMs and their reporting are FDA’s responsibility to ensure patient safety.

Second, in the past FDA has had the opportunity to review the work of any third party reviewer, and reject it if deemed inadequate or shoddy.  In fact, the agency has often found problems with the third party reviews.  The proposed guidance would sharply reduce the agency’s oversight of third party reviews, which will clearly compromise safety.  Even if certified as qualified, third party review companies have an inherent conflict of interest: If their standards are too high, no device company will hire them and they will go out of business.  The system is similar to the EU regulation of medical devices, which has resulted in very harmful decisions, such as the clearance of the PIP breast implants that were found to use non-medical grade silicone.4  In addition, investigative reporters recently obtained CE clearance for a “surgical” mesh that was made out of a plastic mesh bag used for oranges.

Transparency is also a crucial factor.  Currently, third party review companies are not required to clearly label an OEM device indicating that a critical repair has been completed by someone other than the OEM.  Once that repair is made, the device is no longer the same device that was approved or cleared by FDA.  It is important that this chain of accountability is not broken or interrupted.

While we understand the desire of FDA officials to reduce medical device review times and reduce the burden on FDA staff and industry, the 510(k) program already is a quick way to get devices to market and the device industry has clearly benefitted from it.  The 510(k) pathway has been widely criticized by the Institute of Medicine, physicians, patients, and the media for its lack of clinical trials and lack of scientific evidence.5  Despite its weaknesses, the 510(k) pathway is considered superior to the EU regulatory system, however.  By reducing the “burden” for FDA staff and industry, the proposed guidance increases the burden on patients and doctors to figure out which devices are safe and which are not.  This would clearly put U.S. patients at greater risk.

FDA has not demonstrated that its proposed changes to the third party review pathway of Class I and Class II devices will benefit patients.  By definition, 510(k) devices only rarely are substantially superior to recent predicates.  Speeding up the process of clearance is not demonstrated to benefit patients.  Moreover, with registries, NEST, and other planned efforts to improve post-market surveillance still far from effectively implemented, any loosening of 510(k) regulations is very premature.

Finally, we note that Commissioner Gottlieb responded to recent media criticism of CDRH regulations by promising improvements to the 510(k) pathway to ensure patient safety.  The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices.   We strongly oppose it for that reason.

 

References

  1. Zuckerman, D.M., Brown, P, and Nissen, S.E.  (2011) Medical Device Recalls and the FDA Approval Process, Archives of Internal Medicine, 117, 1006-11.
  2. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(11), 1045.
  3. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(21), 1963.
  4. Zuckerman, D., Booker, N, and Nagda, S. (2012) Public Health Implications of Difference in US and European Union Regulatory Policies for Breast Implants, Reproductive Health Matters, 20 (40),102-111.
  5. Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices,  JAMA Internal Medicine, 174(11): 1781-1787.

 

Women’s Health Advocates Question FDA About Missing Safety Data on Silicone Breast Implants

Matthew Perrone, Associated Press: January 5, 2012.

[…] FDA concluded last summer that the silicone-gel implants are basically safe as long as women understand they come with complications. More than one in five women who get implants for breast enhancement will need to have them replaced within five years, the agency’s report concluded.

In August, an outside panel of physicians affirmed the FDA’s decision that the devices should remain available for both breast enhancement and reconstruction.

But the National Research Center for Women and Families says the FDA did not present information that showed women reported lower emotional, mental and physical well-being after implantation. Additionally, the group questions why figures presented by the FDA appear to show implant complications declining over time. The implants are known to fail over time.

“This shows problems with the data, since the complication rates are reported to be cumulative and should therefore stay the same or increase over time,” states Diana Zuckerman, the group’s president, in a letter to the head of FDA’s medical device division.

Most of the FDA’s data on the safety and effectiveness of breast implants comes from long-term studies conducted by the two U.S. manufacturers of the devices, Allergan Inc. of Irvine, Calif., and Mentor, a unit of Johnson & Johnson, based in New Brunswick, N.J.

When the FDA reviewed the initial applications for the devices in 2005, women using Allergan’s implants scored lower on nine out of 12 quality-of-life measures, including mental, social and general health. Women did report higher scores on measures of sexual attractiveness-body esteem.

Women implanted with J&J’s implants also scored worse on measures of physical and mental health. In the 11-page letter, Zuckerman questions why that information was not presented at FDA’s public meeting in August.

“Breast implants are widely advertised and promoted as a way to increase women’s self-esteem and positive feelings about themselves,” said Zuckerman, in an interview with the Associated Press. “But the implant companies’ own data, which the FDA made public in 2005 but ignored last year, shows the opposite.” […]

Breast implants are known to rupture and break down over time. But Zuckerman points out in her letter that the company data seem to defy this trend, with complication rates falling over time.

For instance, Allergan’s reported rate of swelling among patients fell from 23 percent in 2005 to 9 percent reported in 2011. Rates of scarring similarly fell from 8 percent to 4 percent.

“This again raises questions about the accuracy of reporting, and whether patients with complications were excluded from the 10-year sample,” writes Zuckerman. […]

 

Read the original article here.

F.D.A. Affirms Safety of Breast Implants

Gardener Harris, The New York Times: August 31, 2011.

WASHINGTON — After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants.

The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe. […]

Some patients and women’s groups who testified at the meeting disagreed.

Diana Zuckerman, president of the National Center for Health Research, a research and education group, told an expert panel that the two companies that manufacture silicone breast implants — Johnson & Johnson and Allergan — had done a poor job of studying patients who got the implants, as the F.D.A. required them to do.

“And without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes,” Ms. Zuckerman said. […]

There was some criticism of the 27-page research form that patients who participate in the study are required to complete and whether it could be shortened. Nearly all expressed hope that a registry could be created that would follow all breast implant patients, but such registries are expensive to maintain and complicated to create. […]

Read the original article here.

Women’s Health: A Red-Flag Warning

Seattle Post-Intelligencer: January 12, 2007

We’ve never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.

Restricted since 1992, the implants were deemed unsafe because of the health risks associated with them, such as cancer. The FDA currently recommends that only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. and Mentor Corp., to carry out a 10-year, 80,000-patient study in order to “fully answer important questions” regarding the products safety. […]

We spoke to two experts on the matter: Diana Zuckerman, president of the National Research Center for Health Research at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University’s School of Public Health. The two scientists want you to know a few things:

 Post-approval studies are common, but the sheer scope of this one should be a red flag. Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.

 Although you can pay for the implants in installments, you can’t do so for their removal — and they will need to be removed or replaced. Health insurance seldom covers those additional surgeries.

 You’ll need to get pricey MRIs regularly. And no, your insurance probably won’t cover them.

 By no means should you take the FDA’s approval of the implants to mean that they’re safe. For example, their effect on breast milk, says Zuckerman, has “never, ever, ever been tested” by the FDA. […]

Read the original article here.