Dive Brief:

• Expert advisers to the FDA Monday largely downplayed talk of a U.S. ban on textured breast implants, but expressed receptiveness to safety advocates’ calls for a more transparent, mandatory and standardized informed consent process.
• Dozens of patients testified feeling "duped" and "blindsided" by doctors after developing breast implant associated anaplastic large cell lymphoma or breast implant illness (BII). Some called the cancer 'man made'.
• Panelists acknowledged lack of comprehensive and comparable data available from the four PMA-holding manufacturers — Allergan, Johnson & Johnson-owned Mentor, Sientra and newer market entrant Ideal Implant — and indicated the newly established National Breast Implant Registry ought to be a source of more consistent follow-up with patients going forward.

Dive Insight:

The discussion capped the first of a two-day panel focused primarily on how to assess, diagnose, treat and track the cancer of the immune system most often traced to textured breast implants, and BII. FDA noted the latter term originated with patients on social media and could encompass more than 80 different symptoms based on breast implant-related adverse event reports.  

While the lymphoma in particular is called rare, FDA said describing exact incidence rate is challenging given the lack of a conclusive denominator of number of implants placed worldwide, although a number of manufacturer representatives testified they share those figures annually.

In addition to patients testifying before FDA's General and Plastic Surgery Device Panel, plastic surgeons defended benefits of the devices, but acknowledged a need for education among surgeons increasingly interacting with cases of the conditions. About 300,000 breast augmentations and 100,000 breast reconstructions occur in the U.S. each year, according to the American Society of Plastic Surgeons.

FDA presented data showing that the scope of breast implant illness may far exceed the incidence of BIA-ALCL.

Annual breast implant-related MDRs the FDA received reached approximately 50,000 in 2017. While that includes all adverse events, it contrasts the 660 total cases of BIA-ALCL FDA cited in a February press release.

Madris Tomes, former program manager at FDA and founder of Device Events, will testify on Tuesday that her data analysis finds breast implants are the single most reported device from hospitals and surgery centers. While typically only 17% of adverse event reports come from physicians (as opposed to manufacturers or other parties), for breast implants that figure jumps to 37%, according to Tomes' analysis, shared with MedTech Dive.

Mentor and Sientra both received warning letters from FDA last week for failing to fully meet postmarket study requirements. Mentor cited falling rates of textured implant use as a challenge in meeting targets, while Sientra said women generally healthy and satisfied with their implants are often not inclined to participate in follow-up studies.

Among the strategies noted to improve follow-up participation, Sientra said it could offer better financial incentives and reach out to women identified via social media.

Tens of thousands of women affected by breast implant-related disease said they were not given a manufacturer's warning and are now gathered on social media, said patient advocate Jamee Cook, who had explant surgery following BII symptoms and now heads the Breast Implant Victim Advocacy group.

She does not believe patients contemplating implants are made aware that the devices are not designed to last permanently and that the rate of necessary reoperation is high.

"What I will emphasize is: I was not warned," Cook said.

Cook’s wishlist include requiring standardized informed consent by doctors, including a patient checklist and black box warning, enforcing penalties in cases of non-compliance by manufacturers, and mandating industry-funded studies of BIA-ALCL in which findings are made public.

Patient advocates also called for a devices' 'ingredients' lists, now considered trade secrets, to be made public. Silicone is "never inert," said University of Alberta rheumatology expert Jan Willem Cohen Tervaert.  

A handful of breast implant recipients piqued panelists' interest when they testified they have seen chronic illness in children born after having implants. Some women called for research into how breast implant chemicals affect breast milk or potentially infiltrate the placental wall, also recommending a pediatric registry to track symptoms among children of mothers with implants.

Plastic Surgery Foundation President Andrea Pusic, who runs the National Breast Implant Registry, said as of July 1 this year, infrastructure for electronic capture of unique device identifier through a mobile barcode scanning app will allow plastic surgeons to track manufacturers' specific devices, helping to alleviate that current hole in the data.

Pusic asked that FDA consider requiring all U.S. plastic surgeons to participate in the registry from the time of implant. ​Having launched last fall, Pusic estimated that currently only about 200 of some 8,000 members of the American Society of Plastic Surgeons have gotten involved with the registry.

Many MDRs included in FDA's breast implant review lack clear information regarding texture and manufacturer. Presenters and panelists concluded that within the body of implants considered 'textured,' there are actually a variety of types of texturing, meaning some manufacturer's devices could be causing more cases of the lymphoma than others. 

Mark Clemens, a BIA-ALCL researcher at MD Anderson Cancer Center, singled out Allergan's Biocell implants, which were taken off the market in Europe in 2018, as having a particularly egregious track record.

In an earlier statement shared with MedTech Dive, an Allergan spokesperson said the company "stands firmly behind the benefit/risk profile of its breast implant products, including textured breast implants."

End-of-day debate Monday saw some panelists defending the textured option on the grounds that certain reconstructions in particular require a rougher surface to stay in place, and the emerging alternative has been to wrap less controversial smooth implants with surgical mesh, which FDA does not indicate for use in breast procedures.

This alternative, said panelists like University of California at San Francisco plastic surgeon Mary McGrath, could actually be a more harmful option. In other surgical uses, mesh has shown, like breast implants, to not have lifetime durability, and has also resulted in thousands of adverse event reports.

Other panelists noted that incidence of BIA-ALCL among women receiving implants is low, and therefore that pulling all textured implants would be an overreaction.

Even without a ban, use of textured implants in the has declined, with Sientra saying what had been a 50-50 market by texture now skews more like 80-20 in favor of smooth, and Mentor noting that only about 5% of its sales now come from its textured MemoryShape implants.

Tuesday's panel deliberations will pick up with the assessment and characterization of breast implant illness. Discussion is also set to focus on the use of surgical mesh in certain breast procedures and whether FDA should modify its screening recommendations for silent implant rupture to include methods less expensive than MRI.